Roles
- Co-Director Schiff Center for Liver Diseases
- Co-Director Hepatology Diagnostic Research Laboratory
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Education & Training
Education
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Publications
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Clinical Trials
Viewing 0 of 22 clinical trials.
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A Randomized, Open-Label, Multicenter Study Investigating AB-729, Nucleos(t)Ide Analogue and Pegylated Interferon Alfa-2a Treatment in Subjects With Chronic Hepatitis B Infection
- Principal Investigator: Eugene Schiff
- Study Phase: Phase 2
- Enrollment Status: Closed
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Phase 2 Study to Evaluate the Efficacy and Safety of BMS-986263 in Adults With Compensated Cirrhosis From Nonalcoholic Steatohepatitis (NASH)
- Principal Investigator: Eugene Schiff
- Study Phase: Phase 2
- Enrollment Status: Closed
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Placebo-controlled, randomised, double-blind, parallel-groupdesign comparison of 2 arms over 7 years
- Principal Investigator: Eugene Schiff
- Study Phase: Phase III
- Enrollment Status: Open
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Placebo-controlled, randomised, double-blind, parallel-group design comparison of 2 arms over approximately 4.5 years
- Principal Investigator: Eugene Schiff
- Study Phase: Phase III
- Enrollment Status: Open
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- To investigate the efficacy of NNC0194-0499, cagrilintide, semaglutide alone and NNC0194-0499 or cagrilintide in combination with semaglutide versus placebo on liver damage and function in people with alcohol-related liver disease.-To investigate the safety and tolerability of NNC0194-0499, cagrilintide, and semaglutide alone and NNC0194-0499 or cagrilintide in combination with semaglutide versus placebo in people with alcohol-related liver disease.Secondary
- Principal Investigator: Eugene Schiff
- Study Phase: Phase II
- Enrollment Status: Closed
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This is a phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of fazirsiran (TAK-999, previously called ARO-AAT) in the treatment ofparticipants aged 18 to 75 years, inclusive, with PiZZ AATD-LD and METAVIR stage F1 liver fibrosis. Approximately 50 participants are planned to be randomized 1:1 to receive either placebo or fazirsiran administered SC. Participant randomization will be stratified according to baseline lung augmentation therapy (present or absent) and biopsy-confirmed diagnosis of nonalcoholic steatohepatitis (NASH; present or absent). A diagnosis of NASH will be allowed in up to 20% of the participants randomized.
- Principal Investigator: Eugene Schiff
- Study Phase: Phase III
- Enrollment Status: Open
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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
- Principal Investigator: Eugene Schiff
- Study Phase: Phase 2
- Enrollment Status: Not Accepting
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This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess efficacy and safety of treatment with bepirovirsen in participants with chronic HBV infection on-NA treatment. After a 2-part screening-period, this study has 4 stages:• Double-Blind Treatment for 24 weeks• NA Treatment for 24 weeks• NA Cessation with 24-week follow-up OR Continue On-NA for 24 weeks• Durability of response and follow-up for a further 24 weeks for participants whostopped NA treatment at Week 48
- Principal Investigator: Eugene Schiff
- Study Phase: Phase III
- Enrollment Status: Closed
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This is a phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of fazirsiran (TAK-999, previously called ARO-AAT) in the treatment of participants aged 18 to 75 years, inclusive, with AATD-LD and moderate to advanced fibrosis and/or compensated cirrhosis.
- Principal Investigator: Eugene Schiff
- Study Phase: Phase III
- Enrollment Status: Open
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This is a Phase 2 open-label study designed to evaluate the safety, tolerability, and efficacy of regimens containing VIR-2218, VIR-3434, and/or PEG-IFN in non-cirrhotic adult subjects with chronic HBV infection on NRTI therapy.
- Principal Investigator: Eugene Schiff
- Study Phase: Phase II
- Enrollment Status: Closed
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The main purpose of this study is to learn whether treatment with resmetirom compared with placebo for several years can benefit participants by slowing further disease progression and delaying complications of NASH cirrhosis. A placebo is an inactive material that looks like the study drug but does not contain any active study drug. Researchers use a placebo to see if the study drug works better or is safer than taking nothing. From here on, resmetirom and placebo will be referred to as the study drug”.
- Principal Investigator: Eugene Schiff
- Study Phase: Phase III
- Enrollment Status: Not Accepting
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This is a randomized, double -blind, placebo-controlled, parallel-dosing, multi-center study toevaluate the efficacy and safety of Rencofilstat as evidenced by histopathological improvementsin fibrosis in adult NASH subjects with F2 or F3 fibrosis (NASH CRN system). Antifibrotic biomarkeractivity will be evaluated on an exploratory basis. This study consists of 3 phases: (i) Screeningand Randomization; (ii) treatment; and (iii) follow up.
- Principal Investigator: Eugene Schiff
- Study Phase: Phase II/III
- Enrollment Status: Closed
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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. Subjects meeting the studys entry criteria will be randomly assigned in a 3:3:3:2 ratio to 1 of 3 active treatment groups (SEMA + CILO/FIR, SEMA alone, CILO/FIR alone) or placebos-to-match (PTM), as shown in the figure below.Randomization will be stratified by the presence or absence of type 2 diabetes (as determined by medical history or based on screeninglaboratory values if previously undiagnosed [ie, hemoglobin A1c(HbA1c) = 6.5% or fasting plasma glucose = 126 mg/dL, confirmedon repeat testing], and by Enhanced Liver Fibrosis (ELFTM) score(= 11.30 or < 11.30 during screening).
- Principal Investigator: Eugene Schiff
- Study Phase: Phase II
- Enrollment Status: Closed
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A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (Resmetirom) in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation
- Principal Investigator: Eugene Schiff
- Study Phase: Phase 3
- Enrollment Status: Closed
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Prospective Clinical Trial to Detect Liver Cancer Through Quantification of cfDNA Methylation in Blood Samples: A LAM Insight Trial Study
- Principal Investigator: Eugene Schiff
- Study Phase: N/A
- Enrollment Status: Not Accepting
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This is a randomised, multicentre, double-blinded, parallel-group trial comparing semaglutide s.c. 2.4 mg once-weekly versus placebo in subjects with NASH and fibrosis stage 2 or 3.
- Principal Investigator: Eugene Schiff
- Study Phase: Phase III
- Enrollment Status: Not Accepting
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This is a multicenter, randomized, double-blind, placebo-controlled, parallel group Phase 2 study to investigate the efficacy, safety and tolerability of 3 different dose levels of HM15211 over 12 months. HM15211 will be compared to placebo in subjects with biopsy confirmed NASH (stages F1-F3).
- Principal Investigator: Eugene Schiff
- Study Phase: Phase II
- Enrollment Status: Closed
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This is a Phase 3, multinational (conducted at least in US and Europe), multicentre, double-blind, placebo-controlled study to evaluate the efficacy and safety of lanifibranor (800 mg and 1200 mg administered once daily) compared to placebo in adult patients with NASH and F2/F3 liver fibrosis.
- Principal Investigator: Eugene Schiff
- Study Phase: Phase III
- Enrollment Status: Not Accepting
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A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects With Nonalcoholic Steatohepatitis
- Principal Investigator: Eugene Schiff
- Study Phase: Phase 3
- Enrollment Status: Closed
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This is a randomized, double-blind, active-controlled, multicenter Phase 2 study to evaluate the efficacy and safety of 48 weeks of oral (PO) once daily (QD) monotherapy with ALG-000184 versus TDF in TN or CNT HBeAg-positive and HBeAg-negative subjects with chronic HBV infection (inclusive of chronic infection and/or chronic hepatitis)
- Principal Investigator: Eugene Schiff
- Study Phase: Phase II
- Enrollment Status: Open
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Efficacy and Safety Investigation of NNC0194-0499 Co-administered With Semaglutide in Subjects With Non-alcoholic Steatohepatitis: a Dose-ranging, Placebo Controlled Trial
- Principal Investigator: Eugene Schiff
- Study Phase: Phase 2
- Enrollment Status: Closed
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FibroScan measurements (liver shear elasticity) have been shown to correlate with degree of liver fibrosis. The aim of this study is to determine whether FibroScan measurements can be used to identify patients who are most at risk to develop hepatocellular carcinoma (HCC). We will specifically look at how the availability of FibroScan measurements (liver shear elasticity) will hypothetically help physicians with treatment, in altering of therapy, performance of liver biopsy, and scheduled patient followup for HCC screening. Physicians will not use the FibroScan measurement to determine actual treatment, but will combing FibroScan values with other susceptibility markers for HCC development including clincal and genetic covariates.
- Principal Investigator: Eugene Schiff
- Study Phase: N/A
- Enrollment Status: Closed