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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects With Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH) (ATLAS)
Scottsdale/Phoenix, Ariz.
The primary objectives of this study are: - To assess the safety and tolerability of selonsertib (SEL), GS-0976, and GS-9674, administered alone or in combination, in participants with bridging fibrosis or compensated cirrhosis due to Nonalcoholic Steatohepatitis (NASH) - To evaluate changes in liver fibrosis, without worsening of NASH
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the effectiveness and safety of three treatment doses of CC-90001 (100 mg, 200 mg and 400 mg PO QD), compared with placebo, in NASH subjects with Stage 3 and Stage 4 fibrosis. This study is designed to assess response to treatment on measures of fibrosis and other efficacy parameters. It will also assess dose response and overall safety.
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A Phase 2B Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of BMS-986036 (PEG-FGF21) in Adults with Nonalcoholic Steatophepatitis (NASH) and Compensated Liver Cirrhosis
Scottsdale/Phoenix, Ariz.
The purpose of this study is to evaluate the safety and effectiveness of BMS-986036 in adults with nonalcoholic steatophepatitis (NASH) and compensated liver cirrhosis.
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A Phase 2B Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of BMS-986036 (PEG-FGF21) in Adults with Nonalcoholic Steatophepatitis (NASH) and Stage 3 Liver Fibrosis (FALCON 1)
Scottsdale/Phoenix, Ariz.
The purpose of this study is to demonstrate the safety and effectiveness of BMS-986036.in participants with NASH and stage 3 liver fibrosis.
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A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody against Lysyl Oxidase-Like 2 (LOXL2), in Subjects with Compensated Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
Scottsdale/Phoenix, Ariz.
This study is to evaluate the safety and efficacy of simtuzumab (GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH). It will consist of 2 phases:
- Randomized Double-Blind Phase
- Open Label Phase (optional)
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A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like Molecule 2 (LOXL2), in Subjects With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
Scottsdale/Phoenix, Ariz.
This study will evaluate whether simtuzumab (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants with non-alcoholic steatohepatitis (NASH). It will consist of 2 phases: - Randomized Double-Blind Phase - Open Label Phase (optional)
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (STELLAR 3)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH.
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (STELLAR 4)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH.
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A Study to Identify the Frequency of Lysosomal Acid Lipase Deficiency in At-Risk Patient Populations
Scottsdale/Phoenix, Ariz.
The objective of this study is to determine the frequency of Lysosomal Acid Lipase Deficiency (LAL D) by lysosomal acid lipase (LAL) enzyme activity assay in patients who are considered to be at risk.
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CENTAUR: Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Subjects With Liver Fibrosis (CENTAUR)
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine whether Cenicriviroc is effective and safe in the treatment of nonalcoholic steatohepatitis (NASH) in adult subjects with liver fibrosis.
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Multicenter, Randomized Phase 2B Study Evaluating Efficacy, Safety and Tolerability of OCR-002 (Ornithine Phenylacetate) in Hospitalized Cirrhotic Patients With Associated Hyperammonemia and an Episode of Hepatic Encephalopathy STOP-HE Study (STOP-HE)
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.
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Open-label Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
Scottsdale/Phoenix, Ariz.
This rollover study will provide open-label treatment with cenicriviroc and will assess the long-term safety of continued treatment with cenicriviroc in participants who participated in the CENTAUR study 652-2-203 [NCT02217475].
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Pilot Study for the Use of Shortened Preemptive therapy with Glecaprevir/pibrentasvir (G/P) and ezetimibe in Hepatitis C Seronegative Solid Organ Transplant Recipients (Kidney, Heart, Lung and/or Pancreas) of Hepatitis C Viremic Donors
Jacksonville, Fla.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to determine the effectiveness of using a combination of two different drugs in preventing the transmission of HCV from a HCV positive donor to a HCV negative solid organ recipient. Both drugs are FDA-approved. Mavyret™ is currently used commercially to treat Hepatitis C and Zetia® is used commercially to treat high cholesterol.
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