Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin (D-LITE)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Hepatitis C

Treatments: Biological: Pegylated Interferon Lambda (pegIFNλ); Drug: Placebo for Ribavirin (RBV); Drug: BMS-790052 (NS5A Inhibitor); Biological: Pegylated Interferon Alfa-2a (pegIFNα-2a); Drug: Placebo (PBO) for BMS-650032 (Placebo for NS3 Protease Inhibitor); Drug: BMS-650032 (NS3 Protease Inhibitor); Drug: Ribavirin (RBV); Drug: Placebo (PBO) for BMS-790052 (Placebo for NS5A Inhibitor)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01309932

AI452-008

2010-022568-11 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

Study Classification: Pharmacokinetics/ Pharmacodynamics

Enrollment: 165 patients

Sex: All

Ages: 18 to 70 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 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%

Exclusion Criteria:

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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165 participants in 7 patient groups

A1: pegIFNλ+BMS-790052+Placebo for BMS-650032+Ribavirin

Experimental group

Description:

Part A

Treatment:

Drug: Ribavirin (RBV)

Biological: Pegylated Interferon Lambda (pegIFNλ)

Drug: Ribavirin (RBV)

Biological: Pegylated Interferon Lambda (pegIFNλ)

Drug: BMS-790052 (NS5A Inhibitor)

Drug: Ribavirin (RBV)

Drug: BMS-790052 (NS5A Inhibitor)

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

Biological: Pegylated Interferon Lambda (pegIFNλ)

A2: pegIFNλ+BMS-650032+Placebo for BMS-790052+Ribavirin

Experimental group

Description:

Part A

Treatment:

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

Drug: Ribavirin (RBV)

Biological: Pegylated Interferon Lambda (pegIFNλ)

Drug: BMS-650032 (NS3 Protease Inhibitor)

Drug: Ribavirin (RBV)

Biological: Pegylated Interferon Lambda (pegIFNλ)

Drug: Ribavirin (RBV)

Biological: Pegylated Interferon Lambda (pegIFNλ)

Drug: BMS-650032 (NS3 Protease Inhibitor)

A3: pegIFNα-2a+PBO for BMS-790052+PBO for BMS-650032+RBV

Active Comparator group

Description:

Part A

Treatment:

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

Drug: Ribavirin (RBV)

Drug: Ribavirin (RBV)

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

Drug: Ribavirin (RBV)

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

A4: pegIFNλ+BMS-790052+BMS-650032+Ribavirin (24 weeks)

Experimental group

Description:

Part B

Treatment:

Drug: Ribavirin (RBV)

Biological: Pegylated Interferon Lambda (pegIFNλ)

Drug: BMS-650032 (NS3 Protease Inhibitor)

Drug: Ribavirin (RBV)

Biological: Pegylated Interferon Lambda (pegIFNλ)

Drug: BMS-790052 (NS5A Inhibitor)

Drug: Ribavirin (RBV)

Drug: BMS-790052 (NS5A Inhibitor)

Biological: Pegylated Interferon Lambda (pegIFNλ)

Drug: BMS-650032 (NS3 Protease Inhibitor)

A5: pegIFNλ+BMS-790052+BMS-650032+Ribavirin (16 weeks)

Experimental group

Description:

Part B

Treatment:

Drug: Ribavirin (RBV)

Biological: Pegylated Interferon Lambda (pegIFNλ)

Drug: BMS-650032 (NS3 Protease Inhibitor)

Drug: Ribavirin (RBV)

Biological: Pegylated Interferon Lambda (pegIFNλ)

Drug: BMS-790052 (NS5A Inhibitor)

Drug: Ribavirin (RBV)

Drug: BMS-790052 (NS5A Inhibitor)

Biological: Pegylated Interferon Lambda (pegIFNλ)

Drug: BMS-650032 (NS3 Protease Inhibitor)

A6: pegIFNλ+BMS-790052+BMS-650032+Placebo for RBV (24 weeks)

Experimental group

Description:

Part B

Treatment:

Drug: Placebo for Ribavirin (RBV)

Biological: Pegylated Interferon Lambda (pegIFNλ)

Drug: BMS-650032 (NS3 Protease Inhibitor)

Biological: Pegylated Interferon Lambda (pegIFNλ)

Drug: BMS-790052 (NS5A Inhibitor)

Drug: BMS-790052 (NS5A Inhibitor)

Biological: Pegylated Interferon Lambda (pegIFNλ)

Drug: BMS-650032 (NS3 Protease Inhibitor)

Drug: Placebo for Ribavirin (RBV)

A7: pegIFNλ+BMS-790052+BMS-650032+Placebo for RBV (16 weeks)

Experimental group

Description:

Part B

Treatment:

Drug: Placebo for Ribavirin (RBV)

Biological: Pegylated Interferon Lambda (pegIFNλ)

Drug: BMS-650032 (NS3 Protease Inhibitor)

Biological: Pegylated Interferon Lambda (pegIFNλ)

Drug: BMS-790052 (NS5A Inhibitor)

Drug: BMS-790052 (NS5A Inhibitor)

Biological: Pegylated Interferon Lambda (pegIFNλ)

Drug: BMS-650032 (NS3 Protease Inhibitor)

Drug: Placebo for Ribavirin (RBV)