Clinical Trials

Division-sponsored clinical trials currently underway include:

BI-1241.36: Phase III study of BI 207127 in combination with faldaprevir and ribavirin for chronic genotype 1 hepatitis C infection in an extended population of treatment naive patients that include those ineligible to receive peginterferon (Boehringer Ingelheim Pharmaceuticals, Inc.)

ML27900: Non-Interventional, Prospective, Cohort Study of the Effectiveness, Safety, and Utilization of Two Approved Pegylated Interferon-Based Direct Acting Antiviral Triple Therapies in the Management of Genotype 1 Chronic Hepatitis C (Genentech, Inc.)

P06-134: A 5-year Registry Study of Humira (Adalimumab) in Subjects with Moderately to Severely Active Crohn’s Disease (Abbott Labs)
C13008: A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (Millennium Pharmaceuticals, Inc.)
C13007: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study (Millennium Pharmaceuticals, Inc.)
C13006: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study (Millennium Pharmaceuticals, Inc.)
REMICADECRD3001: Trial Comparing Remicade (infliximab) and Placebo in the Prevention of Recurrence in Crohn’s Disease Patients Undergoing Surgical Resection Who Are at an Increased RIsk of Recurrance (PREVENT) (Centocor Research & Development, Inc.)
C13011: Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab (Millennium Pharmaceuticals, Inc.)
CNTO1275CRD3003: Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy (Centocor Research & Development, Inc.)
CNTO1275CRD3001: Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy (Centocor Research & Development, Inc.)
SAR339658 2354-2935-7: Multicenter Study Evaluating Efficacy & Safety of SAR339658 in Patients (Sanofi US Service Inc.)

GS-US-321-0106: A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety & Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like 2 (LOXL2), in subjects with Compensated Cirrhosis Secondary to a Non-Alcoholic Steatohepatitis (Gilead Sciences, Inc.)
GS-US-321-0105: A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety & Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like 2 (LOXL2), in subjects with Advanced Liver Fibrosis but not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (Gilead Sciences, Inc.)
GS-US-321-0102: A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety & Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like 2 (LOXL2), in subjects with Primary Sclerosing Cholangitis (Gilead Sciences, Inc.)
GFT505-212-7: A Multicentre, Randomized, Double Blind, Placebo-Controlled study, with an adaptive design to allow for initial GFT505 80mg dosing versus placebo, followed by a second phase including GFT505 120mg dose, after review of 6-month safety analysis of the 80mg data on at least 50% of patients. (Genfit)

CA182037TACE: A Phase III Study of Brivanib versus Placebo as adjuvant therapy to Trans-Arterial Chemo-Embolization (TACE) in patients with Unresectable Hepatocellular Carcinoma: The Brisk TA Study (Bristol-Myers Squibb Company)

HPN-100-008: A Phase 2, Randomized, Double Blind, Placebo-controlled Study of the Safety and Efficacy of HPN-100 for Maintaining Remission in Subjects with Cirrhosis and Episodic Hepatic Encephalopathy (Hyperion Therapeutics, Inc.)