Multicentre, randomised, double-blind, placebo-controlled, 48-week, Phase III trial to evaluate the efficacy and safety of survodutide administered subcutaneously in participants with overweight or obesity and presumed or confirmed non-alcoholic steatohepatitis (NASH)

Date Added
July 23rd, 2024
PRO Number
Pro00134740
Researcher
Don Rockey

List of Studies


Keywords
Drug Studies, Liver, Obesity, Weight Control
Summary

The purpose of this study is to test whether survodutide helps people living with obesity or overweight and with a confirmed or presumed liver disease called non-alcoholic steatohepatitis (NASH) to reduce liver fat and to lose weight

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
8438768436
blanke@musc.edu

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Compensated Cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Date Added
July 23rd, 2024
PRO Number
Pro00136269
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

Evaluate the effect of pegozafermin compared to placebo in reducing the risk of clinical outcomes measured as a composite endpoint

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
843-876-8439
blanke@musc.edu

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Date Added
June 24th, 2024
PRO Number
Pro00134737
Researcher
Don Rockey

List of Studies


Keywords
Drug Studies, Hepatology, Liver
Summary

The purpose of this study is to evaluate the effect of pegozafermin compared to placebo to see how well pegozafermin might improve liver fibrosis after 52 weeks.

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
8438768439
blanke@musc.edu

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Combination Compared to Zibotentan Monotherapy as well as Zibotentan/Dapagliflozin and Zibotentan Monotherapy Compared to Placebo in Participants with Cirrhosis

Date Added
April 9th, 2024
PRO Number
Pro00134733
Researcher
Don Rockey

List of Studies


Keywords
Body Composition, Digestive System, Drug Studies, Hepatology, Liver
Summary

The purpose of this study is to evaluate the safety of combined zibotentan/dapagliflozin, zibotentan by itself, and a placebo in patients with cirrhosis to evaluated which treats fluid retention the best.

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
8438768439
blanke@musc.edu

A Phase 2a, open-label, randomized, controlled, multicenter, proof of concept study, to assess the efficacy, safety and tolerability of VS-01 on top of standard of care, compared to standard of care alone, in adult patients with acute-on-chronic liver failure (ACLF) grades 1 and 2 and ascites

Date Added
April 2nd, 2024
PRO Number
Pro00131012
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

This is a multi-center, randomized, controlled, open-label, Phase 2a
proof of concept study of VS-01 in adult patients with ACLF grades 1
and 2 and ascites. Approximately 60 patients will be enrolled. Sample
size was calculated to meet the study objectives assuming a 10% dropout rate.

Institution
MUSC
Recruitment Contact
Jad Allam Saab
843-876-7233
allamja@musc.edu

A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants with Primary Biliary Cholangitis (PBC)

Date Added
February 26th, 2024
PRO Number
Pro00130418
Researcher
Don Rockey

List of Studies


Keywords
Digestive System, Drug Studies, Hepatology, Liver, Rare Diseases
Summary

The main goal of this study is to evaluate how well taking oral elafibranor 80 mg daily works, compared to a placebo, in reducing or preventing the occurrence of death, liver transplant, worsening of liver disease, and liver disease-related complications in adults with PBC.

Institution
MUSC
Recruitment Contact
Joshua Inman
(843) 876-4303
inmanj@musc.edu

Alpha-1 Foundation Therapeutic Development Network

Date Added
October 23rd, 2023
PRO Number
Pro00132722
Researcher
Charlie Strange

List of Studies


Keywords
Liver, Lung, Non-interventional, Pulmonary, Rare Diseases
Summary

The Alpha-1 Foundation Therapeutic Development Network (TDN) aims to make it easier to design and carry out clinical trials that enhance the treatment of patients with Alpha-1 Antitrypsin Deficiency (AATD). To achieve this, the TDN will establish a network of clinical trial centers that have enough patients to gather a comprehensive database of clinical and genetic information. This data will be crucial in determining the criteria for including or excluding participants in the trials and in recruiting suitable subjects.

Specifically, this study will enroll participants by in person or remote consent who will allow collection of medical records to be entered into an Alpha-1 TDN database. Participants will then be invited to future clinical trials.

Institution
MUSC
Recruitment Contact
Kristin Neff
843-792-1219
neffk@musc.edu

Occult Gastrointestinal Bleeding Caused by Portal Hypertensive Gastropathy in Patients with Cirrhosis

Date Added
May 11th, 2023
PRO Number
Pro00121305
Researcher
Don Rockey

List of Studies


Keywords
Digestive System, Liver, Stomach
Summary

In this study, we will recruit cirrhotic patients who are undergoing endocscopic procedures as part of their standard of care. Their endoscopies will reveal whether they have portal hypertensive gastropathy. After the procedure, we will ask the patients to provide us with a stool sample, which we will assess for occult GI bleeding. For those patients who DO NOT have occult GI bleeding, they will be contacted every 6 months for 2 years to check whether they have developed GI bleeding.

Institution
MUSC
Recruitment Contact
Sara Hatoum
843 792 0650
hatoum@musc.edu

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

Date Added
April 6th, 2023
PRO Number
Pro00124137
Researcher
Don Rockey

List of Studies


Keywords
Alcohol, Liver
Summary

To evaluate the efficacy of an investigational medication (INT-787) as assessed by disease progression in severe alcohol-associated hepatitis (sAH).

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
843-876-8439
blanke@musc.edu

A Two Part Phase IIa/b Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Dose-ranging Study to Assess Efficacy, Safety, and Tolerability of the Combination of Zibotentan and Dapagliflozin, and Dapagliflozin Monotherapy Versus Placebo in Participants with Cirrhosis with Features of Portal Hypertension

Date Added
December 14th, 2022
PRO Number
Pro00124042
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

The study is designed to evaluate the effects of the combination of zibotentan and
dapagliflozin and dapagliflozin monotherapy versus placebo on the hepatic venous pressure gradient (HVPG) response in participants with cirrhosis with features of portal hypertension at 6 weeks of treatment.

Part A is to evaluate the absolute
change in HVPG at 6 weeks from baseline in participants treated with 2.5 mg zibotentan combined with 10 mg dapagliflozin versus placebo. The primary efficacy objective for Part B is to evaluate the proportion of participants treated with 1, 2.5, or 5 mg zibotentan combined with 10 mg dapagliflozin and 10 mg dapagliflozin monotherapy versus placebo achieving a ≥ 20% decrease in HVPG or a reduction to or below 12 mmHg in HVPG

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
18438768439
blanke@musc.edu



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