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

Date Added
May 11th, 2023
PRO Number
Pro00121305
Researcher
Sara Hatoum

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 Phase 2, Randomized, Double-blind, Placebo-controlled Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Dose Levels of Belcesiran in Patients with Alpha-1 Antitrypsin Deficiency-Associated Liver Disease

Date Added
March 14th, 2023
PRO Number
Pro00123493
Researcher
Charlie Strange

List of Studies


Keywords
Genetics, Liver, Lung
Summary

This study will evaluate the safety and effectiveness of the study drug belcesiran with placebo (an inactive drug treatment) in treating Alpha-1 Antitrypsin Deficiency-Associated Liver Disease AATLD. Belcesiran or placebo will be administered subcutaneously (via a shot) in the thigh or abdomen. About 46 people will take part in this study in about 30 hospitals and clinics worldwide. If deemed eligible, subjects will be randomized (assigned into a group by chance) into 1 of 3 study cohorts (groups). Subjects in Cohorts 1 will be dosed monthly to receive a total of 7 doses. Subjects in Cohort 2 will be dosed monthly to receive a total of 13 doses. Cohort 3 will be dosed monthly for the first 6 months and then quarterly thereafter for a total of 13 doses. Subjects will be given the option for extended treatment in an optional treatment period of an additional 4 to 6 doses of either belcesiran or placebo up to 72 weeks depending on group assignment. Subjects will then enter a follow up period for up to 96 weeks depending on group assignment. Study participation will last up to 192 weeks (3.5 years).

Institution
MUSC
Recruitment Contact
Mary Hayden
843-792-8438
blantonm@musc.edu

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF RIFAXIMIN SOLUBLE SOLID DISPERSION (SSD) TABLETS FOR THE DELAY OF ENCEPHALOPATHY DECOMPENSATION IN CIRRHOSIS (RED-C)

Date Added
March 1st, 2023
PRO Number
Pro00117462
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

The primary objective of this study is to assess the efficacy of rifaximin SSD-40IR versus placebo to delay the occurrence of HE-related hospitalization/emergency department visit/initiation of HE therapies.

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

A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Adaptive Dose- Ranging Study to Assess Safety and Efficacy of Intravenous OCE-205 in Adults Diagnosed with Cirrhosis with Ascites who have Developed Hepatorenal Syndrome- Acute Kidney Injury (HRS-AKI)

Date Added
December 13th, 2022
PRO Number
Pro00123164
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

This study will evaluate male and female subjects between 18 and 70 years of age, diagnosed with decompensated cirrhosis with ascites that have developed HRS-AKI, as defined by International Club of Ascites (ICA) criteria; minimum entry serum
creatinine ≥1.5 mg/dL.

Institution
MUSC
Recruitment Contact
Sara Hatoum
843-876-8439
hatoum@musc.edu

Randomised, double-blind, placebo-controlled and parallel group trial to investigate the effects of two doses (up-titration to a fixed dose regimen) of oral BI 685509 on portal hypertension after 24 weeks treatment in patients with clinically significant portal hypertension (CSPH) in compensated cirrhosis

Date Added
November 17th, 2022
PRO Number
Pro00121158
Researcher
Don Rockey

List of Studies


Keywords
Drug Studies, Hepatology, Liver
Summary

In this Phase II trial the efficacy of treatment in patients with clinically significant portal hypertension (CSPH), in compensated alcohol-related cirrhosis, will be assessed. This will be the first trial in the clinical development of the drug BI 685509 where patients will be treated for 24 weeks, and where the portal pressure will be assessed quantitatively via HVPG measurements. The trial will evaluate both short-term and long-term efficacy. The long-term assessment will be used to rule out any adaptation to sGC activation on portal pressure on chronic treatment. The trial will also provide supportive evidence for the planned Phase III development.

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

A Phase 2, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects with Compensated Cirrhosis (F4) due to Nonalcoholic Steatohepatitis (NASH)

Date Added
July 18th, 2022
PRO Number
Pro00119356
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

This is a Phase 2, randomized, double-blind, double-dummy,
placebo-controlled study evaluating the efficacy and safety of SEMA,
CILO/FIR, and their combination in subjects with compensated
cirrhosis due to NASH.

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

Collection of Blood to Evaluate Epigenomics and Protein Biomarkers for the Detection of Hepatocellular Carcinoma

Date Added
July 7th, 2022
PRO Number
Pro00117885
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

Collection of Blood to Evaluate Epigenomics and Protein Biomarkers for the Detection of Hepatocellular Carcinoma

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

A randomised, double-blind, placebo-controlled, multicentre, Phase 3 study evaluating long-term efficacy and safety of lanifibranor in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis

Date Added
June 21st, 2022
PRO Number
Pro00114993
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage 2 or 3 and consists of 2 parts - Part 1 and Part 2.

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



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