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

Alpha-1 Antitrypsin Disease Cohort: Longitudinal Biomarker Study of Disease Consortium

Date Added
March 16th, 2022
PRO Number
Pro00117423
Researcher
Charlie Strange

List of Studies


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

The purpose of this study is to create a de-identified, public use,
repository of data of Chronic Obstructive Pulmonary Disease (COPD)
patients with by Alpha-1 antitrypsin deficiency (AATD), a rare genetic
condition that can cause COPD and emphysema.

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

Can we change the paradigm in children with Non-Alcoholic Fatty Liver disease using Ultrasound Shear wave elastography as a non-invasive point of care tool?

Date Added
March 1st, 2022
PRO Number
Pro00116969
Researcher
Nagraj Kasi

List of Studies


Keywords
Children's Health, Liver
Summary

This investigator-initiated research study supported by a pilot grant from MUSC-Siemens research collaboration, aims to test the feasibility and reproducibility of Ultrasound Shear wave elastography as a point of care tool in screening for hepatic fibrosis and steatosis in children 9-17 years of age with Non-Alcoholic Fatty Liver Disease.

Institution
MUSC
Recruitment Contact
Nagraj Kasi
843-876-0444
kasi@musc.edu

A Phase 2b, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Saroglitazar Magnesium in Subjects with Nonalcoholic Steatohepatitis and Fibrosis

Date Added
February 24th, 2022
PRO Number
Pro00115086
Researcher
David Koch

List of Studies


Keywords
Liver
Summary

This Phase 2b study is a randomized, double-blind, parallel-arm, placebo-controlled trial to evaluate safety and efficacy of Saroglitazar Magnesium 2 mg and Saroglitazar Magnesium 4 mg compared with placebo in subjects with NASH. Subjects will be randomized 1:1:1 to receive Saroglitazar Magnesium 4 mg, Saroglitazar Magnesium 2 mg, or placebo via IVRS/IWRS. Total duration of the study will be up to 89 weeks including two screening visits (12 weeks), randomization and double-blind treatment phase (76 weeks), and a safety follow-up of 1 week after the last administration of study drug. Subjects will be evaluated at the study site for 14 scheduled visits. During the course of the study subjects will have 2 liver biopsies and 6 transient elastography/FibroScan performed to monitor liver fibrosis.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

An Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of Maralixibat in the Treatment of Subjects with Progressive Familial Intrahepatic Cholestasis (PFIC)

Date Added
February 10th, 2022
PRO Number
Pro00117076
Researcher
Nagraj Kasi

List of Studies


Keywords
Liver, Pediatrics
Summary

This is an Open-label Extension Phase 3 Study to determine whether a study drug called maralixibat is safe and effective in treating itchy skin (pruritus) in children with Progressive Familial Intrahepatic Cholestasis (PFIC). There is currently no treatment approved for PFIC and available medical approaches have limited success.

Open label means both the investigators and the subjects are aware of the drug or treatment being given

A Phase 3 study is large scale trial to confirm and expand information on safety and usefulness of a new drug.

Subjects who participate in this study will receive the study drug. The dose of the study drug will be gradually increased during the study up to a tolerable dose . Subjects will continue to take the medication for about 26 months. Subjects will have approximately 16 study visits over 26 months in this study. Subjects will also be asked questions about health and complete questionnaires at the study visits and as well as at home. A Physical exam and Liver ultrasound will be performed at some study visits. A blood and urine sample will also be collected at some of the study visits.

It is possible that the maralixibat may or may not improve symptoms from PFIC. Even if there is no benefit, other children may benefit from what is learned in this study.

Institution
MUSC
Recruitment Contact
Kenreka Yeadon
843-792-7965
yeadon@musc.edu

Molecular Assessment and Profiling of Liver transplant rEcipients: The MAPLE Study

Date Added
December 23rd, 2021
PRO Number
Pro00115748
Researcher
Jared White

List of Studies


Keywords
Liver, Transplant
Summary

The primary purpose of this registry is to evaluate the feasibility and clinical validation of LiverCare in liver transplant recipients, as part of post-transplant surveillance. LiverCare is an investigational panel test that includes 6 components: 1. AlloSure Liver 2. AlloMap Liver 3. AlloHeme Liver 4. iBox Liver 5. HistoMap Liver 6. AlloID. AlloSure Liver is a research test used to measure donor-derived cell free DNA in Liver transplant recipients. AlloMap Liver is a research gene expression profile test using peripheral blood to establish immune activity and is currently undergoing clinical evaluation and development. iBox Liver is an analytic platform that predicts organ outcomes after transplant using a software algorithm based on information from your medical records and is currently undergoing clinical evaluation and development. AlloHeme Liver is a diagnostic test to measure donor and recipient DNA in the blood. HistoMap Liver is a tissue-based gene expression test using tissue collected from standard of care biopsies to establish immune profiles within the organ and is currently undergoing clinical evaluation and development. AlloID is a blood test that will quantify the presence of more than 100 pathogens including standard post-transplant infectious disease screening such as Cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus, Human Herpesvirus 6 (HHV-6) and viral hepatitis.

Institution
MUSC
Recruitment Contact
Deanna DeHoff
843-792-8522
dehoff@musc.edu

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

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



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