Bashar A. Aqel, M.D.

Closed for Enrollment

• 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

• 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.

• 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.

• 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.

• 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)
• 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)

• 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) Scottsdale/Phoenix, Ariz., Rochester, Minn.

  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.

• 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) Scottsdale/Phoenix, Ariz., Rochester, Minn.

  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.

• CENTAUR: Efficacy And Safety Study Of Cenicriviroc For The Treatment Of Nonalcoholic Steatohepatitis (NASH) In Adult Subjects With Liver Fibrosis 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.

• 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 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.

• 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].

• 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 Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

  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.

• Pilot Study To Assess The Validity Of Liquid Biopsy To Improve Diagnosis, Prognostic Assessment And Disease Monitoring In Patients Undergoing Liver Transplant For Hilar And Intrahepatic Cholangiocarcinoma Scottsdale/Phoenix, Ariz.

  The purpose of this study is to explore the application of “liquid biopsy” in the diagnosis, prognostication and monitoring of cholangiocarcinoma (CCA) patients undergoing liver transplant.