The Center for Liver Disease at the North Shore Long Island Jewish Healthcare System is centered at North Shore University Hospital. The Center performs state of the art clinical trials focusing on the treatment of liver disease in order to bring these new treatments to our patients and their families. The general focus of these trials is to gain a better understanding of the nature and behavior of these diseases in an effort to develop more effective treatments.
The Center is currently recruiting patients for clinical trials in the field of hepatitis C, hepatitis B, primary biliary cirrhosis, and nonalcoholic fatty liver disease.
Clinical trials currently accepting patients for hepatitis C include those patients who have never been treated for hepatitis C, as well as those patients who have been previously treated for chronic hepatitis C. Patients with all degrees of disease including cirrhosis are eligible for these clinical trials. The clinical trials include treatments for genotypes 1, 2, 3, and 4.
The Center is committed to the continued education of its physicians, staff, patients and their families to ensure it remains a forerunner in the arena of liver disease research and treatment. This commitment includes collaboration with other prominent institutions and experts outside of the Center who are regionally, nationally, and internationally situated.
Hepatology/Center for Liver Disease Clinical Trails
We are activity enrolling in the following trials:
- Merck – Long-Term follow-up of subjects in a Phase 1, 2 or 3 clinical trial in with Boceprevir or Narlaprevir was administered for the treatment of Chronic Hepatitis C P05063
- Abbott – A Blinded, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-450 with Ritonavir (ABT-450/r) and ABT-072 Dosed in Combination with Ribavirin (RBV) and Peginterferon alfa-2a (pegIFN) in Chronic Hepatitis C Virus (HCV) Genotype 1-Infected Subjects with Null Response to Prior Standard of Care (SOC) Treatment. M11-601
- Abbott – An Open Label, Randomized, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of two doses of ABT-450 with Ritonavir (ABT-450/r) in combination with ABT-072 with or without Ribavirin (RBV) for 12 or 24 weeks in Treatment-Naïve Subjects with Genotype 1 Chronic Hepatitis C Virus Infection. M11-652
- Intercept Pharmaceuticals phase II PBC (Primary Biliary Cirrhosis) studies – A Phase 3, Dose Response Study of Obeticholic Acid (OCA) in Primary Biliary Cirrhosis 747-301
- Gilead – A Phase 2b, Randomized Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of Response Guided Therapy with GS-9190, GS-9256, Ribavirin (Copegus) and Peginterferon Alfa 2a (Pegasys) in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection GS-US-196-0123
- Gilead – A Phase 2b randomized, double-blind, placebo-controlled trial evaluating response guided therapy with Gs5885 alone or in combination with GS 9451 with peginterferon Alfa 2z and ribavirin in treatment naïve subjects with chronic Hepatitis C infection genotype 1 GS-US-256-0148
- Gilead – A Phase 2b randomized, double-blind, placebo-controlled trial evaluating response guided therapy using combinations of oral amtovoras gs5885 and or 9451 with peinterferon Alfa 2a and Ribavirin in treatment experienced subjects with chronic genotype 1 virus GS-US 256-124
- Gilead – A long term follow-up registry for subjects who achieve a sustained virologic response to treatment in Gilead-Sponsored trials in subjects with chronic Hepatitis C infection GS-US248-0122
- Gilead – A long term follow-up registry study of subjects who did not achieve sustained virologic response in Gilead-Sponsored trials in subjects with chronic Hepatitis C infection GS-US-248-0123
- Pharmasset (Gilead) – Protocol numberA Multi-center, Placebo-Controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics following Oral Administration of PSI-7977 in Combination with Pegylated Interferon and Ribavirin in Treatment-Naïve Patients with Chronic HCV Infection Genotype 1: P7977-0422
- Pharmasset (Gilead) – A phase 3, multicenter randomized, active-controlled study to investigator the safety and efficacy of PSI 7977 and ribavirin for 12 weeks compared to pegylated interferon and rivavirin for 24 weeks in treatment naïve patients with chronic genotype 2 or 3 HCV infection P7977-1231
- Schering Plough – A phase 3, safety and efficacy study of Boceprevir in previously untreated subjects with chronic hepatitis C genotype 1 Protocol P05216
- Schering Plough – Boceprevir and Peginterferon/Ribavirin for the Treatment of Chronic Hepatitis C in Treatment-Naïve Subjects: A Comparison of Erythropoeitin use vs. Ribavirin Dose Reduction for the Management of Anemia P06086
- Vertex – Extended: A 3-Year, Virology Follow up Study in Subjects Previously Treated with Teleprevir in Selected Clinical Studies VX08-950-112
- CLDF-MER-001-00 – Study population comprises of HCV treatment Naïve, HCV Previous Partial Responder or Relapsers, HCV Patients with Compensated Cirrhosis, and HCV Historic Null Responder patients with Genotype 1 Meds used = Boceprevir 800mg po TID + Peg+RBV
- VX -222-106 – Study population of treatment naïve patients with Compensated Cirrhosis; partial and null responders with Genotype 1 Meds used = Telaprevir + Peg + RBV
- BMS AI444-043 – HCV co infected study HIV naïve patients with genotype 1a/b = Meds used = BMS 790052 60mg/QD + Peg + RBV
- BMS AI447-028 – An Open Label Study with BMS-790052 and BMS-650032 (DUAL) Null/Partial Responders to P/R; P/R Ineligible-Naïve/Tolerant Subjects with Genotype 1b
- BMS AI447-029 – Open Label Study with BMS-790052 + BMS-650032 Plus Peginterferon and Ribavirin (QUAD) Null/Partial Responders to P/R with GT 1a/1b
- Idenix: IDX-08C-008 – An Open-Label Study to Evaluate the Safety and Efficacy of IDX184 in Combination with Telaprevir and Ribavirin for 12 Weeks in Subjects with Genotype 1 Chronic Hepatitis C Infection
- HoffmannLa Roche NV22688 – A long-term monitoring study to evaluate the persistence of direct acting antiviral (daa) treatment-resistant mutations or the durability of sustained virological response (svr) in patients treated with DAA-containing regimens for chronic hepatitis c infection (chc)
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