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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-09-30

Brief Summary

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Substudy C: The purpose of this substudy is to determine whether Lambda combined with Ribavirin and Daclatasvir for 12 weeks is efficacious in treatment naïve subjects with genotype 1b chronic HCV infection

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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Substudy C: Pegylated Interferon Lambda+Ribasphere+Daclatasvir

Pegylated Interferon Lambda 180 μg Solution, Subcutaneous Once weekly for 12 weeks;

Ribasphere 1000 mg for subjects weighing \< 75 kg and 1200 mg for subjects weighing ≥ 75 kg oral tablets per day \[subjects should take either 400 mg for subjects \< 75 kg or 600 mg ≥ 75 kg in the morning with food and 600 mg in the evening with food\] for 12 weeks;

Daclatasvir 60 mg oral tablet Once daily for 12 weeks

Group Type EXPERIMENTAL

Pegylated Interferon Lambda

Intervention Type BIOLOGICAL

Ribasphere

Intervention Type DRUG

Daclatasvir

Intervention Type DRUG

Interventions

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Pegylated Interferon Lambda

Intervention Type BIOLOGICAL

Ribasphere

Intervention Type DRUG

Daclatasvir

Intervention Type DRUG

Other Intervention Names

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BMS-914143 Ribavirin BMS-790052

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No