Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3 (PRINCIPAL)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Virus (HCV)

Treatments: Drug: Ribavirin; Biological: Pegylated interferon alfa-2a (pegIFNα-2a); Drug: Daclatasvir; Drug: Placebo matching Daclatasvir; Biological: Pegylated interferon lambda (pegIFNλ)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01616524

AI452-017

2011-004885-14 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin

Enrollment: 880 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Chronic hepatitis C, Genotype 2 or 3
• Naïve to prior anti-HCV therapy

Exclusion Criteria:

• Infected with HCV other than Genotype 2 or 3
• Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening
• Evidence of liver disease other than HCV
• Active substance abuse
• Evidence of decompensated cirrhosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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880 participants in 3 patient groups

Arm 1: pegIFNλ + Ribavirin + Placebo matching Daclatasvir

Experimental group

Treatment:

Biological: Pegylated interferon lambda (pegIFNλ)

Drug: Placebo matching Daclatasvir

Drug: Ribavirin

Biological: Pegylated interferon lambda (pegIFNλ)

Drug: Ribavirin

Arm 2: pegIFNλ + Ribavirin + Daclatasvir

Experimental group

Treatment:

Biological: Pegylated interferon lambda (pegIFNλ)

Drug: Ribavirin

Biological: Pegylated interferon lambda (pegIFNλ)

Drug: Daclatasvir

Drug: Ribavirin

Arm 3: pegIFNα-2a + Ribavirin + Placebo matching Daclatasvir

Experimental group

Treatment:

Drug: Placebo matching Daclatasvir

Drug: Ribavirin

Biological: Pegylated interferon alfa-2a (pegIFNα-2a)

Drug: Ribavirin