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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

NCT01616524 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 880

Last updated 2015-10-09

No results posted yet for this study

Summary

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

Conditions

  • Hepatitis C Virus (HCV)

Interventions

BIOLOGICAL

Pegylated interferon lambda (pegIFNλ)

Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks

BIOLOGICAL

Pegylated interferon lambda (pegIFNλ)

Syringe, Subcutaneous, 180 μg, Once weekly, 12 weeks

BIOLOGICAL

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

Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks

DRUG

Ribavirin

Tablets, Oral, 400 mg, Twice daily, 24 weeks

DRUG

Ribavirin

Tablets, Oral, 400 mg, Twice daily, 12 weeks

DRUG

Daclatasvir

Tablets, Oral, 60 mg, Once daily, 12 weeks

DRUG

Placebo matching Daclatasvir

Tablets, Oral, 0 mg, Once daily, 12 weeks

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-06-30
Completion
2014-09-30

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Chile
  • Finland
  • France
  • Greece
  • Hong Kong
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • New Zealand
  • Russia
  • Singapore
  • South Korea
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01616524 on ClinicalTrials.gov