Hepatitis C | Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
Hepatitis C research study
What is the primary objective of this study?
Substudy C: The purpose of this substudy is to determine whether Lambda combined with Ribavirin and Daclatasvir for 12 weeks is efficacious in treatment naïve subjects with genotype 1b chronic HCV infection
Who is eligible to participate?
Inclusion Criteria: - Chronic Hepatitis C, Genotype 1 - HCV RNA >100,000 IU/mL at screening; - Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg); - Liver biopsy within prior 2 years; subjects with compensated cirrhosis can enroll and will be capped at approximately 10% Exclusion Criteria: - Any evidence of liver disease other than HCV; - Co-infection with HIV; - Diagnosed or suspected hepatocellular carcinoma; - Medical history or laboratory value abnormalities that would prohibit the use of Pegylated Interferon Alpha-2a or Ribavirin
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Biological:Pegylated Interferon Lambda
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Substudy C: Pegylated Interferon Lambda+Ribasphere+DaclatasvirPegylated Interferon Lambda 180 μg Solution, Subcutaneous Once weekly for 12 weeks; Ribasphere 1000 mg for subjects weighing < 75 kg and 1200 mg for subjects weighing ≥ 75 kg oral tablets per day [subjects should take either 400 mg for subjects < 75 kg or 600 mg ≥ 75 kg in the morning with food and 600 mg in the evening with food] for 12 weeks; Daclatasvir 60 mg oral tablet Once daily for 12 weeks
Start Date: March 2013
Completed Date: September 2014
Phase: Phase 2
Primary Outcome: Antiviral activity, as determined by the proportion of non-cirrhotic HCV GT-1b subjects with 12-week sustained virologic response (SVR12), defined as HCV RNA < LLOQ target detected or not detected
Secondary Outcome: Proportion of non-cirrhotic HCV GT-1b subjects with eRVR, defined as HCV RNA < LLOQ target not detected
Study sponsors, principal investigator, and references
Principal Investigator: Bristol-Myers Squibb
Lead Sponsor: Bristol-Myers Squibb