Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin

Completed · Phase 2

Conditions studied: Hepatitis C

In brief

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

Key facts

Study ID

NCT01795911

Run by

Bristol-Myers Squibb

People needed

165

Starts

2013-03-01

Expected to finish

2014-09-01

Last updated by the study team

2015-10-09

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• Alamo Medical Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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