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

Summary

The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC) compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48 weeks.

Conditions

• Hepatitis C

Interventions

BIOLOGICAL

Pegylated Interferon Lambda (pegIFNλ)

Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 or 48 weeks depending on response

DRUG

BMS-790052 (NS5A Inhibitor)

Tablets, Oral, 60 mg, Once daily, 24 weeks

DRUG

Ribavirin (RBV)

Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks

DRUG

BMS-650032 (NS3 Protease Inhibitor)

Tablets, Oral, 200 mg, Twice daily, 24 weeks

BIOLOGICAL

Pegylated Interferon Alfa-2a (pegIFNα-2a)

Solution, Subcutaneous, 180 μg/mL, Once weekly, 48 weeks

BIOLOGICAL

Pegylated Interferon Lambda (pegIFNλ)

Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 weeks

DRUG

Ribavirin (RBV)

Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 weeks

BIOLOGICAL

Pegylated Interferon Lambda (pegIFNλ)

Solution, Subcutaneous, 180 μg/mL, Once weekly, 16 weeks

DRUG

Ribavirin (RBV)

Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 16 weeks

DRUG

BMS-790052 (NS5A Inhibitor)

Tablets, Oral, 60 mg, Once daily, 16 weeks

DRUG

BMS-650032 (NS3 Protease Inhibitor)

Tablets, Oral, 200 mg, Twice daily, 16 weeks

DRUG

Placebo (PBO) for BMS-650032 (Placebo for NS3 Protease Inhibitor)

Tablets, Oral, 0 mg, Twice daily, 24 weeks

DRUG

Placebo (PBO) for BMS-790052 (Placebo for NS5A Inhibitor)

Tablets, Oral, 0 mg, Once daily, 24 weeks

DRUG

Placebo for Ribavirin (RBV)

Tablets, Oral, 0 mg, Twice daily, 24 weeks

DRUG

Placebo for Ribavirin (RBV)

Tablets, Oral, 0 mg, Twice daily, 16 weeks

Sponsors & Collaborators

• Bristol-Myers Squibb

  lead INDUSTRY

Principal Investigators

• Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-03-31

Primary Completion

2014-07-31

Completion

2014-09-30

Countries

• United States
• Australia
• France
• Germany
• Italy
• Japan
• New Zealand
• Puerto Rico
• Spain

Study Locations