Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C

Withdrawn before enrolling · Phase 3

Conditions studied: Hepatitis C Virus (HCV)

In brief

The purpose of this study is to determine if 48 weeks of therapy with Pegylated Interferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Pegylated Interferon Alfa-2a plus Ribavirin.

Key facts

Study ID

NCT01447394

Run by

Bristol-Myers Squibb

People needed

0

Starts

2012-03-01

Expected to finish

2014-08-01

Last updated by the study team

2012-02-03

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 or 4
• HCV Ribonucleic acid (RNA) ≥ 100,000 IU/mL at screening
• Liver biopsy documenting no cirrhosis (within prior 2 years) or cirrhosis (from any time prior to randomization). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease. Subjects with compensated cirrhosis can enroll and will be capped at 10%
• Naive to prior anti-HCV therapy

You may not qualify if…

• Infected with HCV other than Genotype 1 or 4
• Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody or hepatitis D virus (HDV) at screening
• Evidence of liver disease other than HCV
• Active substance abuse
• Use of hematologic growth factors within 90 days prior to study randomization
• Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria

Where it is running

• Local Institution — Rochester, New York, United States
• Local Institution — Houston, Texas, United States
• Local Institution — Vancouver, British Columbia, Canada
• Local Institution — Vaughan, Ontario, Canada
• Local Institution — Hong Kong, Hong Kong, China
• Local Institution — Bogotá, Colombia
• Local Institution — Cali, Colombia
• Local Institution — Medellín, Colombia
• Local Institution — Hradec Králové, Czechia
• Local Institution — Prague, Czechia
• Local Institution — Ústí nad Labem, Czechia
• Local Institution — Shebin Elkom, Monufia Governorate, Egypt
• Local Institution — Cairo, Egypt
• Local Institution — Lai Chi Kok, Hong Kong
• Local Institution — Tai Po, Hong Kong
• Local Institution — Budapest, Hungary
• Local Institution — Budapest, Hungary
• Local Institution — Debrecen, Hungary
• Local Institution — Miskolc, Hungary
• Local Institution — Hyderabad, Andhra Pradesh, India
• Local Institution — Coimbatore, India
• Local Institution — Gurgaon, India
• Local Institution — Ludhiana, India
• Local Institution — Nagpur, India
• Local Institution — San Diego, California, United States

Full record on ClinicalTrials.gov

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