A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors

Date Added
July 3rd, 2025
PRO Number
Pro00145386
Researcher
Theodore Gourdin

List of Studies


Keywords
Cancer, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung, Drug Studies, Liver, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with recurrent, progressive as well as advanced, metastatic hepatocellular carcinoma (HCC), cervical cancer (CC), melanoma, head and neck squamous cell carcinoma (HNSCC) or non-small cell lung cancer (NSCLC). The study is testing an investigational drug called DB-1311. Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of the study is to determine the recommended phase II dose of DB-1311 in combination with BNT327 or DB-1311 in combination with DB-1305 by assessing the safety and tolerability. The drug is given to participants by IV infusion. Participants in this study can expect to be in this study for 72 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Prospective non-interventional, phase IV, multicenter, study to assess the effectiveness, safety, and tolerability of elafibranor 80mg/day in patients with PBC receiving treatment in real-world settings

Date Added
June 3rd, 2025
PRO Number
Pro00136802
Researcher
Don Rockey

List of Studies


Keywords
Liver, Non-interventional, Rare Diseases
Summary

This is an international, multicenter, study that will not prescribe elafibranor. It is designed primarily to collect data and assess real-world effectiveness of treatment with elafibranor 80mg/day on adult patients with PBC, and to describe the safety of this treatment and its impact on their quality of life, over a period of 24 months.

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

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF EFRUXIFERMIN IN SUBJECTS WITH NON-CIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH)/METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS (MASH) AND FIBROSIS

Date Added
May 9th, 2025
PRO Number
Pro00141743
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

Primary objective is to evaluate the effect of EFX compared to placebo on achieving
NASH/MASH resolution AND fibrosis regression at Week 52 (in
Cohort 1 only) and to evaluate the effect of EFX compared to placebo on all-cause
mortality and liver-related clinical outcomes as measured by the
time to first occurrence of any of the predefined, adjudicated events
in subjects with NASH/MASH and fibrosis.

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

A Phase 3. Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Date Added
March 27th, 2025
PRO Number
Pro00138507
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with NASH/MASH cirrhosis and fibrosis stage 4.

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



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