Safety and Efficacy Study of Peginterferon Lambda-1a vs. Peginterferon Alfa-2a, Plus Ribavirin in Subjects With Genotype 1 Hepatitis C (BASIS)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Virus (HCV)

Treatments: Drug: Ribavirin; Biological: Peginterferon Lambda-1a; Biological: Peginterferon alfa-2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT01754974

2012-003508-11 (EudraCT Number)

AI452-033

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic hepatitis C, Genotype 1
• HCV RNA ≥100,000 IU/mL at screening
• Liver biopsy documenting no cirrhosis (within prior 3 years). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease
• Naïve to prior anti-HCV therapy

Exclusion criteria

• Infected with HCV other than Genotype 1
• Positive Hepatitis B Surface Antigen (HBsAg), or Human Immunodeficiency Virus (HIV)-1/HIV-2 antibody 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 history of cirrhosis based on radiologic criteria or biopsy results and clinical criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Peginterferon Lambda-1a + Ribavirin

Experimental group

Description:

Peginterferon Lambda-1a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks

Treatment:

Biological: Peginterferon Lambda-1a

Drug: Ribavirin

Peginterferon alfa-2a + Ribavirin

Active Comparator group

Description:

Peginterferon alfa-2a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks

Treatment:

Biological: Peginterferon alfa-2a

Drug: Ribavirin