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Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C

NCT01447394 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2012-02-03

No results posted yet for this study

Summary

The purpose of this study is to determine if 48 weeks of therapy with Pegylated Interferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Pegylated Interferon Alfa-2a plus Ribavirin.

Conditions

  • Hepatitis C Virus (HCV)

Interventions

BIOLOGICAL

Pegylated Interferon Lambda

Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks

BIOLOGICAL

Pegylated Interferon Alfa-2a

Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks

DRUG

Ribavirin

Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 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
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-03-31
Completion
2014-08-31

Countries

  • United States
  • Canada
  • China
  • Colombia
  • Czechia
  • Egypt
  • Hong Kong
  • Hungary
  • India
  • Ireland
  • Netherlands
  • Poland
  • Romania
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • 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 NCT01447394 on ClinicalTrials.gov