Title: A Phase 2a, Double-Blind, Randomized, Active Controlled, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Bezafibrate Administered in Combination with Obeticholic Acid in Subjects with Primary Biliary Cholangitis STUDY NUMBER: 747-214
Brief Title: Intercept 747-214
Brief Summary: Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in
combination with the investigational drug obeticholic acid (OCA) in participants with
Primary Biliary Cholangitis (PBC).
For info regarding 2021P000895
please contact Julie Shea at 617-632-1125 or
jmshea@bidmc.harvard.edu
Title: A Phase 2a, Double-Blind, Randomized, Active Controlled, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Bezafibrate Administered in Combination with Obeticholic Acid in Subjects with Primary Biliary Cholangitis STUDY NUMBER: 747-214
Brief Title: Intercept 747-214
Brief Summary: Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in
combination with the investigational drug obeticholic acid (OCA) in participants with
Primary Biliary Cholangitis (PBC).
For info regarding 2021P000895
please contact Liver Center Trials Office at 617-632-1118 or
abonder@bidmc.harvard.edu
Title: A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating The Safety And Efficacy of CM-101 In Subjects With Primary Sclerosing Cholangitis- The SPRING STUDY (CM-101-PSC-101)
Brief Title: Chemomab: The SPRING STUDY (CM-101-PSC-101)
Brief Summary: This study is designed to assess the safety, tolerability and activity of the anti-human
CCL24 monoclonal antibody CM-101 in adult subjects with Primary Sclerosing Cholangitis
(PSC). At least 68 subjects at approximately 50 sites will be randomized to receive
either CM-101 at doses of 10 mg/kg or 20 mg/kg or matching placebo.
For info regarding 2022P000656
please contact Julie Shea at 617-632-1125 or
jmshea@bidmc.harvard.edu
Title: A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating The Safety And Efficacy of CM-101 In Subjects With Primary Sclerosing Cholangitis- The SPRING STUDY (CM-101-PSC-101)
Brief Title: Chemomab: The SPRING STUDY (CM-101-PSC-101)
Brief Summary: This study is designed to assess the safety, tolerability and activity of the anti-human
CCL24 monoclonal antibody CM-101 in adult subjects with Primary Sclerosing Cholangitis
(PSC). At least 68 subjects at approximately 50 sites will be randomized to receive
either CM-101 at doses of 10 mg/kg or 20 mg/kg or matching placebo.
For info regarding 2022P000656
please contact Liver Center Trials Office at 617-632-1118 or
abonder@bidmc.harvard.edu
Title: A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects with Primary Biliary Cholangitis
Brief Title: Intercept 977-311
Brief Summary: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose
Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with
Primary Biliary Cholangitis (PBC).
For info regarding 2024P000549
please contact Alan Bonder at
abonder@bidmc.harvard.edu
Title: A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects with Primary Biliary Cholangitis
Brief Title: Intercept 977-311
Brief Summary: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose
Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with
Primary Biliary Cholangitis (PBC).
For info regarding 2024P000549
please contact Liver Center Trials Office at 617-632-1118 or
abonder@bidmc.harvard.edu
Title: A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (PSC) (CLIN-60190-453)
Brief Title: CLIN-60190-453
Brief Summary: This study will evaluate the effects of elafibranor (the study drug) in participants with
Primary Sclerosing Cholangitis (PSC). PSC is a rare disease of the liver that leads to
injury and destruction of bile ducts. Damage to bile ducts leads to buildup of bile in
the liver, which then causes further damage, and leads to disease progression. This study
will compare elafibranor to a placebo, a dummy treatment. The main objective of the trial
will be to study the safety and side effects of the study drug. The trial will also study
the study drug's effects on blood tests and other tests related to PSC disease activity.
For info regarding 2023P000297
please contact Alan Bonder at
abonder@bidmc.harvard.edu
Title: A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (PSC) (CLIN-60190-453)
Brief Title: CLIN-60190-453
Brief Summary: This study will evaluate the effects of elafibranor (the study drug) in participants with
Primary Sclerosing Cholangitis (PSC). PSC is a rare disease of the liver that leads to
injury and destruction of bile ducts. Damage to bile ducts leads to buildup of bile in
the liver, which then causes further damage, and leads to disease progression. This study
will compare elafibranor to a placebo, a dummy treatment. The main objective of the trial
will be to study the safety and side effects of the study drug. The trial will also study
the study drug's effects on blood tests and other tests related to PSC disease activity.
For info regarding 2023P000297
please contact Liver Center Trials Office at 617-632-1118 or
abonder@bidmc.harvard.edu
Title: A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Sclerosing Cholangitis (VISTAS)
Brief Title: Volixibat VLX-301 Study
Brief Summary: The purpose of this clinical research study is to learn more about the use of the study
medicine, volixibat, for the treatment of pruritus (itching) associated with Primary
Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease
progression of PSC.
For info regarding 2021P000450
please contact Julie Shea at 167-632-1125 or
jmshea@bidmc.harvard.edu
Title: A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Sclerosing Cholangitis (VISTAS)
Brief Title: Volixibat VLX-301 Study
Brief Summary: The purpose of this clinical research study is to learn more about the use of the study
medicine, volixibat, for the treatment of pruritus (itching) associated with Primary
Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease
progression of PSC.
For info regarding 2021P000450
please contact Liver Center Trials Office at 617-632-1118 or
abonder@bidmc.harvard.edu
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (VANTAGE)
Brief Title: Mirum VLX-601 VANTAGE Study
Brief Summary: The purpose of this clinical research study is to learn more about the use of the study
medicine, volixibat, for the treatment of pruritus (itching) associated with Primary
Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression
of PBC.
For info regarding 2021P000960
please contact Julie Shea at 617-632-1125 or
jmshea@bidmc.harvard.edu
Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (VANTAGE)
Brief Title: Mirum VLX-601 VANTAGE Study
Brief Summary: The purpose of this clinical research study is to learn more about the use of the study
medicine, volixibat, for the treatment of pruritus (itching) associated with Primary
Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression
of PBC.
For info regarding 2021P000960
please contact Liver Center Trials Office at 617-632-1118 or
abonder@bidmc.harvard.edu
Title: AFFIRM: A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Brief Title: AFFIRM: CB8025-41837
Brief Summary: To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary
Biliary Cholangitis (PBC) and Compensated Cirrhosis.
For info regarding 2023P000565
please contact Alan Bonder at
abonder@bidmc.harvard.edu
Title: AFFIRM: A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Brief Title: AFFIRM: CB8025-41837
Brief Summary: To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary
Biliary Cholangitis (PBC) and Compensated Cirrhosis.
For info regarding 2023P000565
please contact Liver Center Trials Office at 617-632-1118 or
abonder@bidmc.harvard.edu
Title: ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
Brief Title: ASSURE CB8025-31731 PBC Study
Brief Summary: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in
Subjects with Primary Biliary Cholangitis (PBC)
For info regarding 2022P000561
please contact Julie Shea at 617-632-1125 or
jmshea@bidmc.harvard.edu
Title: ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
Brief Title: ASSURE CB8025-31731 PBC Study
Brief Summary: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in
Subjects with Primary Biliary Cholangitis (PBC)
For info regarding 2022P000561
please contact Liver Center Trials Office at 617-632-1118 or
abonder@bidmc.harvard.edu
Title: IDEAL: A 52-week, Double-blind, Placebo-controlled, Randomized, Phase 3 study Intended to Determine the Effects of seladelpar on normalization of Alkaline phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA)
Brief Title: IDEAL: CB8025-32251
Brief Summary: To Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in
Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance
to Ursodeoxycholic Acid (UDCA)
For info regarding 2023P000749
please contact Alan Bonder at
abonder@bidmc.harvard.edu
Title: IDEAL: A 52-week, Double-blind, Placebo-controlled, Randomized, Phase 3 study Intended to Determine the Effects of seladelpar on normalization of Alkaline phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA)
Brief Title: IDEAL: CB8025-32251
Brief Summary: To Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in
Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance
to Ursodeoxycholic Acid (UDCA)
For info regarding 2023P000749
please contact Liver Center Trials Office at 617-632-1118 or
abonder@bidmc.harvard.edu
Title: Multidimensional Approach to Frailty among Liver Transplant Recipients: A Pilot Study
Brief Title: Frailty in Liver Transplantation: A Pilot Study
For info regarding 2021P000902
please contact Alan Bonder at
abonder@bidmc.harvard.edu
Title: Multidimensional Approach to Frailty among Liver Transplant Recipients: A Pilot Study
Brief Title: Frailty in Liver Transplantation: A Pilot Study
For info regarding 2021P000902
please contact Liver Center Trials Office at 617-632-1118 or
abonder@bidmc.harvard.edu
Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-escalation, Proof-of-Concept Study Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics of INT-787 in Subjects with Severe Alcohol Associated Hepatitis
Brief Title: Intercept
Brief Summary: The purpose of this trial is to assess dose related safety, efficacy, and
pharmacokinetics (PK) of INT-787 in participants with severe alcohol-associated hepatitis
(sAH).
For info regarding 2023P000214
please contact Liver Center Trials Office at 617-632-1118 or
mcurry@bidmc.harvard.edu
Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-escalation, Proof-of-Concept Study Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics of INT-787 in Subjects with Severe Alcohol Associated Hepatitis
Brief Title: Intercept
Brief Summary: The purpose of this trial is to assess dose related safety, efficacy, and
pharmacokinetics (PK) of INT-787 in participants with severe alcohol-associated hepatitis
(sAH).
For info regarding 2023P000214
please contact Michael Curry at 617-632-9852 or
mcurry@bidmc.harvard.edu
Title: Molecular Assessment and Profiling of Liver Transplant Recipients: The Maple Study
Brief Title: The Maple Study
Brief Summary: The objective of this protocol is to conduct longitudinal and prospective studies of
liver transplant recipients, using a multimodality approach, akin to that used in kidney
transplantation. The primary aim will compare the clinical outcomes of LiverCare
post-transplant surveillance in liver transplant with standard of care consisting of
liver function tests, DSA measurements, drug level monitoring, and 'for cause' biopsy.
The protocol will assess the correlation between clinical events (e.g. rejection,
recurrent disease, biliary obstruction), dd-cfDNA levels, gene expression profiling,
ability to assess microchimerism, develop predictive analytics, infectious disease
diagnoses and finally examine graft histology.
For info regarding 2021P000848
please contact Liver Center Trials Office at 617-632-1118 or
mcurry@bidmc.harvard.edu
Title: Molecular Assessment and Profiling of Liver Transplant Recipients: The Maple Study
Brief Title: The Maple Study
Brief Summary: The objective of this protocol is to conduct longitudinal and prospective studies of
liver transplant recipients, using a multimodality approach, akin to that used in kidney
transplantation. The primary aim will compare the clinical outcomes of LiverCare
post-transplant surveillance in liver transplant with standard of care consisting of
liver function tests, DSA measurements, drug level monitoring, and 'for cause' biopsy.
The protocol will assess the correlation between clinical events (e.g. rejection,
recurrent disease, biliary obstruction), dd-cfDNA levels, gene expression profiling,
ability to assess microchimerism, develop predictive analytics, infectious disease
diagnoses and finally examine graft histology.
For info regarding 2021P000848
please contact Michael Curry at 617-632-9852 or
mcurry@bidmc.harvard.edu
Title: The Liver Incytes System, evaluation of liver fibrosis and steatosis versus MRE and MRI-PDFF SI-CLIN-02
Brief Title: Fibroscan Study
Brief Summary: Evaluate the feasibility of the Liver Incyte system for liver elasticity measurement in
healthy volunteers and patients with liver fibrosis. To evaluate the discriminatory
ability of elasticity measurements generated by Liver Incyte for healthy volunteers
versus patients with liver fibrosis in comparison to FibroScan measurements.
For info regarding 2018P000730
please contact Liver Center Trials Office at 617-632-1118 or
mcurry@bidmc.harvard.edu
Title: Alcoholic Hepatitis Patient Registry
Brief Title: Alcoholic Hepatitis Patient Registry
For info regarding 2018P000055
please contact Liver Center Trials Office at 617-632-1118 or
zgjiang@bidmc.harvard.edu
Title: End-Stage Liver Disease Patient Registry and Biorepository (ESLD Registry)
Brief Title: ESLD Patient Registry
For info regarding 2019P000954
please contact Liver Center Trials Office at 617-632-1118 or
zgjiang@bidmc.harvard.edu
Title: Spatial transcriptomics studies of liver disease
Brief Title: Spatial transcriptomics studies of liver disease
For info regarding 2021P000448
please contact Liver Center Trials Office at 617-632-1118 or
zgjiang@bidmc.harvard.edu
Title: Spatial transcriptomics studies of liver disease
Brief Title: Spatial transcriptomics studies of liver disease
For info regarding 2021P000448
please contact Zhenghui Jiang at 617-308-7203 or
zgjiang@bidmc.harvard.edu
Title: Transplant Institute Biorepository
Brief Title: Transplant Institute Biorepository
For info regarding 2015P000311
please contact Liver Center Trials Office at 617-632-1118 or
zgjiang@bidmc.harvard.edu
Title: Very low density lipoprotein lipidomics in liver diseases
Brief Title: VLDL lipidomics
For info regarding 2024P000806
please contact Liver Center Trials Office at 617-632-1118 or
zgjiang@bidmc.harvard.edu
Title: Very low density lipoprotein lipidomics in liver diseases
Brief Title: VLDL lipidomics
For info regarding 2024P000806
please contact Zhenghui Jiang at 617-308-7203 or
zgjiang@bidmc.harvard.edu
Title: Whole Exome Sequencing in adult patients with unexplained illness or unusual disease phenotypes
Brief Title: Exome sequencing in unexplained adult disease
For info regarding 2019P001102
please contact Liver Center Trials Office at 617-632-1118 or
zgjiang@bidmc.harvard.edu
Title: A cross-sectional study of hepatocellular carcinoma screening
Brief Title: Hepatocellular carcinoma screening
For info regarding 2020P000244
please contact Liver Center Trials Office at 617-632-1118 or
mlai@bidmc.harvard.edu
Title: A cross-sectional study of non-alcoholic fatty liver disease in a type 2 diabetes primary care cohort
Brief Title: NAFLD and Type 2 Diabetes Mellitus in Primary Care
For info regarding 2019P000886
please contact Liver Center Trials Office at 617-632-1118 or
mlai@bidmc.harvard.edu
Title: A Global FibroScan Study
Brief Title: Global FibroScan Study
For info regarding 2022P001122
please contact Liver Center Trials Office at 617-632-1118 or
mlai@bidmc.harvard.edu
Title: A Global FibroScan Study
Brief Title: Global FibroScan Study
For info regarding 2022P001122
please contact Michelle Lai at 617-632-1118 or
mlai@bidmc.harvard.edu
Title: A Phase 2b, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Saroglitazar Magnesium in Subjects with Nonalcoholic Steatohepatitis and Fibrosis
Brief Title: Saroglitazar Magnesium for the Treatment of Nonalcoholic Ste
Brief Summary: Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis
For info regarding 2021P000736
please contact Julie Shea at 617-632-1129 or
jmshea@bidmc.harvard.edu
Title: A Phase 2b, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Saroglitazar Magnesium in Subjects with Nonalcoholic Steatohepatitis and Fibrosis
Brief Title: Saroglitazar Magnesium for the Treatment of Nonalcoholic Ste
Brief Summary: Saroglitazar Magnesium for the Treatment of Nonalcoholic Steatohepatitis
For info regarding 2021P000736
please contact Liver Center Trials Office at 617-632-1118 or
mlai@bidmc.harvard.edu
Title: A Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Effect of Resmetirom on Liver-related Outcomes in Patients with Well-compensated (Child-Pugh A) Non-alcoholic Steatohepatitis (NASH) Cirrhosis
Brief Title: MAESTRO-NASH OUTCOMES MGL-3196-19
Brief Summary: This study will determine the effect of oral 80 mg resmetirom administered once daily on
participants with well-compensated non-alcoholic steatohepatitis (NASH) cirrhosis by
measuring the time to experiencing a Composite Clinical Outcome event.
For info regarding 2024P000014
please contact Liver Center Trials Office at 617-632-1118 or
mlai@bidmc.harvard.edu
Title: A Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Effect of Resmetirom on Liver-related Outcomes in Patients with Well-compensated (Child-Pugh A) Non-alcoholic Steatohepatitis (NASH) Cirrhosis
Brief Title: MAESTRO-NASH OUTCOMES MGL-3196-19
Brief Summary: This study will determine the effect of oral 80 mg resmetirom administered once daily on
participants with well-compensated non-alcoholic steatohepatitis (NASH) cirrhosis by
measuring the time to experiencing a Composite Clinical Outcome event.
For info regarding 2024P000014
please contact Michelle Lai at 617-632-1118 or
mlai@bidmc.harvard.edu
Title: A randomized, double-blind, placebo- controlled, multicentre, Phase 3 study evaluating efficacy and safety of lanifibranor followed by an active treatment extension in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis
Brief Title: 337HNAS20011 (NATiV3)
Brief Summary: This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver
fibrosis histological stage F2 or F3
For info regarding 2022P000050
please contact Julie Shea at 617-632-1129 or
jmshea@bidmc.harvard.edu
Title: A randomized, double-blind, placebo- controlled, multicentre, Phase 3 study evaluating efficacy and safety of lanifibranor followed by an active treatment extension in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis
Brief Title: 337HNAS20011 (NATiV3)
Brief Summary: This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver
fibrosis histological stage F2 or F3
For info regarding 2022P000050
please contact Liver Center Trials Office at 617-632-1118 or
mlai@bidmc.harvard.edu
Title: Cirrhosis Registry for Hepatocellular Carcinoma Development
Brief Title: HCC Registry
For info regarding 2019P000881
please contact Liver Center Trials Office at 617-632-1118 or
mlai@bidmc.harvard.edu
Title: Cirrhosis Registry for Hepatocellular Carcinoma Development
Brief Title: HCC Registry
For info regarding 2019P000881
please contact Michelle Lai at 617-632-1118 or
mlai@bidmc.harvard.edu
Title: Cirrhosis Registry for Hepatocellular Carcinoma Development: Analysis of Dietary Patterns across Socioeconomic Status
Brief Title: Cirrhosis Registry for HCC: Analysis of SES & Diet
For info regarding 2021P000778
please contact Liver Center Trials Office at 617-632-1118 or
mlai@bidmc.harvard.edu
Title: Cirrhosis Registry for Hepatocellular Carcinoma Development: Analysis of Dietary Patterns across Socioeconomic Status
Brief Title: Cirrhosis Registry for HCC: Analysis of SES & Diet
For info regarding 2021P000778
please contact Michelle Lai at 617-632-1118 or
mlai@bidmc.harvard.edu
Title: Non-alcoholic Steatohepatitis Registry for Bariatric Surgery Patients
Brief Title: Non-alcoholic Steatohepatitis in Bariatric Surger
For info regarding 2018P000107
please contact Liver Center Trials Office at 617-632-1118 or
mlai@bidmc.harvard.edu
Title: A pilot study to characterize interferon-induced gene expression in liver cells and peripheral blood lymphocytes using high density oligonucleotide microarray expression analysis in caucasian and African American patients with chronic hepatitis C
Brief Title: IFN-induced gene expression in liver cells in PBL
For info regarding 2006P000254
please contact Daryl Lau at 617-632-1118 or
dlau@bidmc.harvard.edu
Title: A pilot study to characterize interferon-induced gene expression in liver cells and peripheral blood lymphocytes using high density oligonucleotide microarray expression analysis in caucasian and African American patients with chronic hepatitis C
Brief Title: IFN-induced gene expression in liver cells in PBL
For info regarding 2006P000254
please contact Liver Center Trials Office at 617-632-1118 or
dlau@bidmc.harvard.edu
Title: Application of MRI, Fibroscan and serum biomarker (LiverFast score) to evaluate hepatic fibrosis and steatosis in patients with chronic hepatitis B or metabolic syndrome
Brief Title: Non-invasive tests to assess fibrosis and steatosis
For info regarding 2022P000185
please contact Daryl Lau at 617-632-1118 or
dlau@bidmc.harvard.edu
Title: Application of MRI, Fibroscan and serum biomarker (LiverFast score) to evaluate hepatic fibrosis and steatosis in patients with chronic hepatitis B or metabolic syndrome
Brief Title: Non-invasive tests to assess fibrosis and steatosis
For info regarding 2022P000185
please contact Liver Center Trials Office at 617-632-1118 or
dlau@bidmc.harvard.edu
Title: CD1- reactive liver NKT cells in hepatitis, cirrhosis, and hepatocellular
Brief Title: CD1- reactive liver NKT cells in hepatitis, cirrho
For info regarding 2005P000105
please contact Liver Center Trials Office at 617-632-1118 or
dlau@bidmc.harvard.edu
Title: CD1-Reactive Blood-NKT Cells In Anti-tumor Responses
Brief Title: CD1-Reactive Blood-NKT Cells In Anti-tumor Respons
For info regarding 2008P000347
please contact Liver Center Trials Office at 617-632-1118 or
dlau@bidmc.harvard.edu
Title: Clinical Samples Inventory for Hepatitis B and Hepatitis C Research
Brief Title: Clinical Samples Inventory for Hepatitis B and Hepatitis C
For info regarding 2011P000054
please contact Liver Center Trials Office at 617-632-1118 or
dlau@bidmc.harvard.edu
Title: Combination Therapy of Peginterferon Alfa-2a and Tenofovir versus Tenofovir Monotherapy in HBeAg-positive and HBeAg-Negative Chronic Hepatitis B
Brief Title: Combination Therapy of Peginterferon Alfa-2a and T
Brief Summary: This clinical trial compares the efficacy of peginterferon plus tenofovir for 24 weeks
followed by monotherapy with tenofovir for a further 3.5 years to the efficacy of
tenofovir alone given for 4 years in patients with chronic hepatitis B. The primary
measure of outcome will be HBsAg loss in serum at 48 weeks after stopping all antiviral
therapy (sustained off-treatment response).
For info regarding 2012P000310
please contact Liver Center Trials Office at 617-632-1118 or
dlau@bidmc.harvard.edu
Title: Comparison of viral titers and proteins between serum and saliva of patients with viral hepatitis using standardized molecular assays
Brief Title: Correlation study on viral levels in saliva and serum
For info regarding 2015P000171
please contact Liver Center Trials Office at 617-632-1118 or
dlau@bidmc.harvard.edu
Title: Factors affecting the pathogenesis and progression of chronic liver disease
Brief Title: Pathogenesis of chronic liver disease
For info regarding 2008P000299
please contact Liver Center Trials Office at 617-632-1118 or
dlau@bidmc.harvard.edu
Title: Hepatitis D education and awareness program among primary health care providers
Brief Title: HDV awareness program
For info regarding 2023P000514
please contact Daryl Lau at 617-632-1118 or
dlau@bidmc.harvard.edu
Title: Hepatitis D education and awareness program among primary health care providers
Brief Title: HDV awareness program
For info regarding 2023P000514
please contact Liver Center Trials Office at 617-632-1118 or
dlau@bidmc.harvard.edu
Title: Hepatitis D virus (HDV) screening among chronic hepatitis B patients
Brief Title: HDV screening among chronic hepatitis B patients
For info regarding 2023P000555
please contact Daryl Lau at 617-632-1118 or
dlau@bidmc.harvard.edu
Title: Hepatitis D virus (HDV) screening among chronic hepatitis B patients
Brief Title: HDV screening among chronic hepatitis B patients
For info regarding 2023P000555
please contact Liver Center Trials Office at 617-632-1118 or
dlau@bidmc.harvard.edu
Title: Innate Immunity to HCV Infection
Brief Title: Innate Immunity to HCV Infection
For info regarding 2011P000057
please contact Liver Center Trials Office at 617-632-1118 or
dlau@bidmc.harvard.edu
Title: LIAISON MUREX Anti-HDV Clinical Performance Study
Brief Title: DiaSorin LIAISON MUREX Anti-HDV Assay
For info regarding 2024P000680
please contact Daryl Lau at 617-632-1118 or
dlau@bidmc.harvard.edu
Title: LIAISON MUREX Anti-HDV Clinical Performance Study
Brief Title: DiaSorin LIAISON MUREX Anti-HDV Assay
For info regarding 2024P000680
please contact Liver Center Trials Office at 617-632-1118 or
dlau@bidmc.harvard.edu
Title: Observational study of persons with Hepatitis B Virus infection in North America (Cohort Study)
Brief Title: Observational study of persons with Hepatitis B Vi
Brief Summary: The primary purpose of this study is to describe participants with hepatitis B virus
(HBV) infection and identify factors that may cause the disease to activate or worsen.
For info regarding 2010P000172
please contact Liver Center Trials Office at 617-632-1118 or
dlau@bidmc.harvard.edu
Title: Phase 1 of a non-Invasive novel assay that detects integrated HBV DNA by utilizing HBV-host junction sequences (HBV-JS) in urine in Patients with Chronic Hepatitis B Virus Infection
Brief Title: HBV-JS in urine in Patients with Chronic Hepatitis B Virus I
For info regarding 2022P000146
please contact Daryl Lau at 617-632-1118 or
dlau@bidmc.harvard.edu
Title: Phase 1 of a non-Invasive novel assay that detects integrated HBV DNA by utilizing HBV-host junction sequences (HBV-JS) in urine in Patients with Chronic Hepatitis B Virus Infection
Brief Title: HBV-JS in urine in Patients with Chronic Hepatitis B Virus I
For info regarding 2022P000146
please contact Liver Center Trials Office at 617-632-1118 or
dlau@bidmc.harvard.edu
Title: Pilot study to evaluate immunological response of hepatitis B virus during pregnancy
Brief Title: Immune responses of HBV during pregnancy
For info regarding 2017P000103
please contact Liver Center Trials Office at 617-632-1118 or
dlau@bidmc.harvard.edu
Title: The application of a highly sensitive platform technology to detect viral titers and biomarkers of chronic liver diseases
Brief Title: The application of a highly sensitive platform tec
For info regarding 2014P000069
please contact Liver Center Trials Office at 617-632-1118 or
dlau@bidmc.harvard.edu
Title: A Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Safety and Efficacy of Zetomipzomib (KZR-616) in Patients with Autoimmune Hepatitis
Brief Title: KZR-616-208
For info regarding 2023C000218
please contact Liver Center Trials Office at 617-632-1118 or
vpatward@bidmc.harvard.edu
Title: A Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Safety and Efficacy of Zetomipzomib (KZR-616) in Patients with Autoimmune Hepatitis
Brief Title: KZR-616-208
For info regarding 2023C000218
please contact Vilas Patwardhan at 617-632-1070 or
vpatward@bidmc.harvard.edu
Title: Boston Primary Sclerosing Cholangitis Consortium
Brief Title: BeaCon
For info regarding 2019C001067
please contact Liver Center Trials Office at 617-632-1118 or
vpatward@bidmc.harvard.edu
Title: Characterization of patients with autoimmune and cholestatic liver diseases
Brief Title: Autoimmune liver registry
For info regarding 2018P000019
please contact Liver Center Trials Office at 617-632-1118 or
vpatward@bidmc.harvard.edu