A Randomized, Double-blind, Placebo-controlled, Phase 2b study to Evaluate Safety and Efficacy of DUR-928 in Subjects with Alcoholic Hepatitis

Date Added
September 14th, 2021
PRO Number
Pro00109938
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

There is a new investigational drug called DUR-928. This study is being done to see if this investigational drug helps in the treatment of Alcoholic Hepatitis (AH).

The hope is that the use of DUR-928 will lead to lowering the MELD (Model for end-stage liver disease) score, some other liver blood tests, and then other symptoms of AH may get better.

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

A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid

Date Added
July 13th, 2021
PRO Number
Pro00110190
Researcher
Don Rockey

List of Studies


Keywords
Drug Studies, Liver, Rare Diseases
Summary

This is an experimental drug trial to study a new drug, elafibranor, in patients with Primary Biliary Cholangitis (PBC). The main objective of this study is to evaluate the effect of daily oral 80mg elafibranor for 52 weeks on the treatment of cholestasis (impairment of bile formation and/or bile buildup) in patients with PBC. Elafibranor is a medicine being developed by Genfit Pharmaceuticals that is designed to work differently than any other available medications for PBC. In addition to decreasing bile acid formation, increasing bile acid uptake, and detoxifying bile acids like medications that work similarly to elafibranor, elafibranor additionally has anti-inflammatory effects that Genfit believes will provide additional health benefits to patients with PBC.

Persons interested in participation will need to complete at least 1, but no more than 3, Screening Visits at the Main Campus of the Medical University of South Carolina (MUSC) in Charleston, SC in order to determine eligibility. If enrolled, you will have up to 21 study visits with the study doctor at MUSC over a period of at least 52 weeks (1 year) and up to a maximum of 312 weeks (6 years). At study visits you will be asked to complete up to 7 study-related questionnaires and complete any study-related testing such as physical exams, medical imaging, lab work (such as blood or urine tests), etc.

Institution
MUSC
Recruitment Contact
Joshua Inman
843-876-4303
inmanj@musc.edu or liverstudies@musc.edu

VK2809 A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF VK2809 ADMINISTERED FOR 52 WEEKS FOLLOWED BY A 4-WEEK OFF-DRUG PHASE IN SUBJECTS WITH BIOPSY PROVEN NON-ALCOHOLIC STEATOHEPATITIS WITH FIBROSIS

Date Added
July 6th, 2021
PRO Number
Pro00109573
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

The purpose of this study is to find out about the safety and effectiveness of a study medicine (VK2809) in study subjects with non-alcoholic steatohepatitis (NASH) with fibrosis. The study will take approximately 64 weeks to complete, with study (clinic) visits approximately every 4 weeks.

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

The effect of semaglutide in subjects with non-cirrhotic non-alcoholic steatohepatitis

Date Added
April 13th, 2021
PRO Number
Pro00108809
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

The purpose of this study is to find out about the safety and effectiveness of an investigation drug called Semaglutide for the treatment of NASH. (Non-Alcoholic Steatohepatitis). NASH occurs when the fat buildup in the liver leads to inflammation (hepatitis) and scarring. NASH is associated with increased risk of morbidity (medical problem or complication) and mortality (death). Currently, treatment options are few and insufficient. There is therefore an unmet medical need for effective and safe pharmacological treatment options. The study is designed to last 257 weeks (approximately 4 years and 11 months), with study visits occurring approximately every 4 weeks. Most visits will include blood work and some will include assessments such as body weight and vital signs. Most visits will include reviewing of diary entries during the course of the study. This study also includes weekly injections of semaglutide (or placebo). Semaglutide is a self-administered injection that is given under the skin. Semaglutide has built an extensive amount of data with other trials that have focused on weight management and Type 2 diabetes. Semaglutide is FDA-approved for diabetes treatment, but is investigational for this study. In these previous trials, semaglutide was found to be safe and well-tolerated. This study is randomized, double-blinded, and placebo-controlled. This means that you may receive the study drug or a placebo. Neither the study subject or the study team members will know which each subject will be receiving. Study subjects will be randomized 2:1. This means that subjects will have a greater chance (66%) of receiving the drug versus the placebo.

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

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, DOSE-RANGING, DOSE-FINDING, PARALLEL GROUP STUDY TO ASSESS EFFICACY AND SAFETY OF PF-06865571 (DGAT2I)ALONE AND WHEN COADMINISTERED WITH PF-05221304 (ACCI) IN ADULT PARTICIPANTS WITH BIOPSY-CONFIRMED NONALCOHOLIC STEATOHEPATITIS AND FIBROSIS STAGE 2 OR 3

Date Added
January 12th, 2021
PRO Number
Pro00100274
Researcher
Don Rockey

List of Studies


Keywords
Diabetes
Summary

The purpose of this research study is to learn if the study drugs (PF-06865571 alone or when given together with PF-05221304) improve NASH with liver fibrosis compared to placebo. The study drug is an IV infusion that would be administered in the outpatient clinic at MUSC main campus.

The medical term for this condition is nonalcoholic steatohepatitis (NASH) that has both high liver fat and inflammation (swelling) and fibrosis (scarring) that causes a stiff liver. This research study involves two investigational drugs (study drugs) being developed by Pfizer Inc. as potential options to treat participants with NASH.

This study is just over a year long and will involve 18 visits to MUSC

Institution
MUSC
Recruitment Contact
Megan Bickford
843-876-8439
bickfome@musc.edu

A Seamless, Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis

Date Added
October 13th, 2020
PRO Number
Pro00100506
Researcher
Don Rockey

List of Studies


Keywords
Aging, Liver
Summary

The purpose of this study is to find out about the safety and effectiveness of Belapectin (GR-MD-002) (an oral investigational drug - not approved by the FDA) for the prevention of esophageal varices in NASH (Non-Alcoholic Steatohepatitis) Cirrhosis. The study is designed to last 156 weeks with study visits occurring every 2 weeks.

Institution
MUSC
Recruitment Contact
Megan Bickford
843-876-8439
liverstudies@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Non-Cirrhotic Subjects with Primary Sclerosing Cholangitis

Date Added
June 25th, 2019
PRO Number
Pro00087383
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

This is a Phase 3, randomized, double-blind, placebo-controlled study
evaluating the safety and efficacy of GS-9674 in subjects with PSC
without cirrhosis.

The study will consist of an 8-week Screening period,96 weeks of treatment, and a follow-up visit 4 weeks after completion of treatment. (Patients would be required to come to MUSC for 12 visits for a physical check-up, blood work, and to receive more study medication).

If the subject qualifies they will be randomized into one of two groups. The two groups include one receiving 100mg active GS-9674 or placebo. There is a 2/3 chance to be receiving active drug over placebo. The drug GS-9674 is a capsule that is taken once a day in the morning (with or without food).

The purpose of this study is to see if GS-9674 slows the scarring process in subjects with PSC.

Institution
MUSC
Recruitment Contact
Brittiny Bowers
843-876-8439
liverstudies@musc.edu

Introducing Palliative Care (PC) within the Treatment of End Stage Liver Disease (ESLD): A Cluster Randomized Controlled Trial

Date Added
December 18th, 2018
PRO Number
Pro00084674
Researcher
Don Rockey

List of Studies


Keywords
Alcohol, Cancer/Gastrointestinal, Liver, Pain
Summary

This is a two armed multicenter cluster randomized controlled trial (RCT), to assess the effectiveness of two pragmatic PC models for patients with ESLD (Consultative PC vs. Trained hepatologist led PC). To prevent bias at the level of providers, randomization will take place at the level of clinical centers; however patients will be the unit of inference. Parallel to this cluster-RCT, a qualitative study will be undertaken to evaluate the patient/caregiver experiences in the two PC models, using semi structured interviews.

To execute this project, Duke has identified 19 clinical centers to participate; 8 Veterans Health Administration (VHA) systems and 11 non-VHA, Academic Medical Centers.

Comparative Approaches:
1.Consultative PC led approach (Model 1): The PC model will include: 1) routine PC consults, using a standardized checklist , 2) in-person visits at initial, 1 and 3 months.
2.Trained hepatologist led PC (Model 2): The Hepatologist Led PC model will comprise: 1) Hepatologist training (through E Learning modules), and 2) in person visits utilizing the same PC checklist as utilized in Model 1. The in-person visits will occur at initial, 1 and 3 months i.e. similar to Model 1 and follow the same visit specified agenda.

MUSC has been assigned to the Model 2 approach, "Hepatologist led Palliative Care" to be lead by Dr. Don Rockey and Dr. Heather Simpson.

Adult patients 18 years of age or older will be enrolled. With 14 clinical centers in different geographic locations and diversity in race/ ethnicity, 1260 patient/ caregiver dyads will be enrolled.

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

The reversibility of liver fibrosis after HCV eradication

Date Added
March 15th, 2018
PRO Number
Pro00076212
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

This an observational study that aims to assess the outcome of patients with advanced fibrosis and cirrhosis recurrence in patients with hepatitis C virus (HCV) infection after HCV eradication. We aim to describe this unique group of patients as well as determine whether any particular variables are significant predictors of fibrosis/cirrhosis resolution. A multivariate analysis will be conducted to determine risk factors independently related to fibrosis/cirrhosis resolution and clinical outcome.

Institution
MUSC
Recruitment Contact
Shaurya Prakash
843-860-8059
prakash@musc.edu

Comparison of 24-hours versus 72-hours of octreotide infusion along with endoscopic therapy in preventing early rebleed from esophageal varices: a multi-center, randomized clinical study

Date Added
July 16th, 2013
PRO Number
Pro00027015
Researcher
Don Rockey

List of Studies


Keywords
Digestive System, Esophagus, Liver, Vascular
Summary

The study will compare two durations of treatment with Octreotide in patients with confirmed esophageal variceal hemorrhage who have undergone successful endoscopy and possible endoscopic therapy for control of bleeding. All procedures including the treatment are the standard of care. Octreotide infusion and endoscopic therapy for esophageal variceal bleeding are not investigational.

Institution
MUSC
Recruitment Contact
Mary Hart
843-876-8439
hartmm@musc.edu



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