South Carolina Research Studies Directory

A Single-blind, Phase 2, Multi-center, Randomized Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of the Relaxin Agonist R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients with Hepatorenal Syndrome – Acute Kidney Injury

Date Added
November 21st, 2024
PRO Number
Pro00139091
Researcher
Don Rockey

List of Studies


Keywords
Kidney
Summary

This is a randomized, single-blind controlled, two group, multicenter trial
preceded by a safety run-in, in patients with Hepatorenal Syndrome (HRS) –
Acute Kidney Injury (HRS-AKI) to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of the Relaxin Agonist R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients.

Institution
MUSC
Recruitment Contact
Jad Allam Saab
843-876-8439
allamj@musc.edu

A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of denifanstat in patients with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) and F2/F3 fibrosis (FASCINATE-3)

Date Added
November 25th, 2024
PRO Number
Pro00138888
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

To evaluate the effect of denifanstat 50 mg compared to placebo in reducing the risk of liver-related composite clinical outcome.
To evaluate the effect of denifanstat 50 mg compared to placebo after 52 weeks of treatment on achieving:
- MASH resolution without worsening of fibrosis,
OR
- Fibrosis regression without worsening of steatohepatitis.

Institution
MUSC
Recruitment Contact
Joshua Inman
843-876-8439
inmanj@musc.edu

A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of denifanstat in patients with metabolic dysfunction-associated steatotic liver disease (MASLD)/metabolic dysfunction-associated steatohepatitis (MASH)

Date Added
December 19th, 2024
PRO Number
Pro00138889
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

To evaluate the safety and tolerability of
denifanstat 50 mg compared to placebo in patients
with MASLD/MASH after 52 weeks of treatment.

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



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