Clinical Studies for Digestive Disease Center

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Title: A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel Study Evaluating the Safety and Efficacy of LB-P8 in Patients with Primary Sclerosing Cholangitis (PSC)
Brief Title: LB08-211 Trial
Brief Summary: The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.
For info regarding 2025P000764 please contact Alan Bonder at 617-632-1070 or abonder@bidmc.harvard.edu
 
Title: A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel Study Evaluating the Safety and Efficacy of LB-P8 in Patients with Primary Sclerosing Cholangitis (PSC)
Brief Title: LB08-211 Trial
Brief Summary: The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.
For info regarding 2025P000764 please contact Liver Center Trials Office at 617-632-1118 or abonder@bidmc.harvard.edu
 
Title: Prospective Multicenter Clinical Performance Study of a Single-use Large Channel Digital Pancreaticobiliary Scope (DPS) with Compatible Accessories
Brief Title: Dragonfly Pancreaticobiliary Scope
Brief Summary: This study plans to enroll up to 75 research subject who have a biliary disorder such as bile duct stones or intermediate biliary strictures. The purpose of this research is to assess whether the Dragonfly™ Pancreaticobiliary Scope functioned as intended in combination with the commercially available accessories during your scheduled endoscopy procedure. This includes achieving stone fragmentation of difficult biliary stone(s) while obtaining adequate tissue specimens for analysis. There will also be a Product performance evaluation as rated by the endoscopist operating the DPS System and evaluation of ergonomics and usability.
For info regarding 2025P000505 please contact Douglas Pleskow at 617-632-8623 or dpleskow@bidmc.harvard.edu
 
Title: Prospective Non-Interventional, Phase Iv Multicentre Study To Assess The Effectiveness, Safety And Tolerability Of Elafibranor 80 Mg/Day In Patients With Primary Biliary Cholangitis Receiving Treatment In A Real-World Setting
Brief Title: ELFINITY CLIN-60190-461
Brief Summary: This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting. PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms including pruritus (itching) and fatigue. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. In this study the main aim is to observe the effectiveness, safety and tolerability of elafibranor in participants with PBC who are receiving treatment in real world setting. The total study duration for each participants will be 60 months (approximately 5 years).
For info regarding 2024P000905 please contact Alan Bonder at 617-632-1070 or abonder@bidmc.harvard.edu
 
Title: Prospective Non-Interventional, Phase Iv Multicentre Study To Assess The Effectiveness, Safety And Tolerability Of Elafibranor 80 Mg/Day In Patients With Primary Biliary Cholangitis Receiving Treatment In A Real-World Setting
Brief Title: ELFINITY CLIN-60190-461
Brief Summary: This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting. PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms including pruritus (itching) and fatigue. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done. In this study the main aim is to observe the effectiveness, safety and tolerability of elafibranor in participants with PBC who are receiving treatment in real world setting. The total study duration for each participants will be 60 months (approximately 5 years).
For info regarding 2024P000905 please contact Liver Center Trials Office at 617-632-1118 or abonder@bidmc.harvard.edu
 
Title: Immune and metabolic characterization of patients with alcohol-associated hepatitis
Brief Title: Characterization of AH
Brief Summary: This research study aims to establish a clinical database and biorepository to gain a deeper understanding of the causes and mechanisms of illnesses like alcoholic-associated hepatitis and other diseases. This involves the collection of blood samples (referred to as biological samples) and personal health information from both healthy and sick participants for potential use in future investigations into alcoholic-associated hepatitis or other diseases. A biological sample typically refers to blood but may include any bodily fluid. Personal Health Information encompasses details such as name, age, gender, race, and medical history, as well as data from prior research participation or routine medical examinations.
For info regarding 2024P000164 please contact Ruchi Chauhan at 617-735-2886 or rchauhan@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 617-632-1070 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 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: 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: Alcoholic Hepatitis Network Clinical Study
Brief Title: AlcHepNet Clinical Study
Brief Summary: The purpose of this research study is to create a clinical database and bio-repository. To do this, we will obtain blood, urine, saliva, and stool samples (e.g., biological samples) and personal health information from you to use in future research studies related to alcoholic hepatitis or other diseases. Part of your blood sample will be used to extract your DNA. DNA is the genetic material that gives us unique characteristics. We are doing this research study because we are trying to find out more about how and why illnesses related to alcoholic hepatitis or other diseases occur in people. To do this, we will study the biological samples and personal health information from healthy and sick people. A "biological sample" is usually blood, but can be any body fluid. "Personal Health Information" includes such items as your name, age, gender, race, and/or your medical information. It can also include data from measurements and tests that you had while participating in another research study or that were done during the course of your regular medical care or doctor visits.
For info regarding 2019C000971 please contact Liver Center Trials Office at 617-667-9050 or gszabo1@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