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Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir

NCT01598090 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 881

Last updated 2019-07-31

Study results available
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Summary

The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.

Conditions

  • Hepatitis C Virus

Interventions

BIOLOGICAL

Peginterferon Lambda-1a

Syringes, subcutaneous (SC), 180μg, Once weekly, 24 or 48 weeks depending on response

BIOLOGICAL

Peginterferon Alfa-2a

Syringes, SC, 180μg, Once weekly, 24 or 48 weeks depending on response

DRUG

Ribavirin

Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 24 or 48 weeks depending on response

DRUG

Telaprevir

Tablets, Oral, 750 mg, three times a day, 12 weeks only

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-14
Primary Completion
2015-02-04
Completion
2015-05-15

Countries

  • United States
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • France
  • Germany
  • Israel
  • Italy
  • Poland
  • Russia
  • Spain
  • Switzerland
  • 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 NCT01598090 on ClinicalTrials.gov