CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 881 enrolled
Drug / intervention
Peginterferon Lambda-1a +3 morebiological
Likely dose
Peginterferon Lambda-1a 180μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01598090
NCT01598090Phase 3Completed
CompareCT.gov

A Phase 3 Blinded Randomized Study of Peginterferon Lambda-1a and Ribavirin Compared to Peginterferon Alfa-2a and Ribavirin, Each Administered With Telaprevir in Subjects With Genotype-1 Chronic Hepatitis C Who Are Treatment-naive or Relapsed on Prior Treatment With Peginterferon Alfa-2a and Ribavirin

Bristol-Myers Squibb·interventional·Posted May 15, 2012·Updated Jul 31, 2019

In Brief

A Phase 3 clinical trial evaluating Peginterferon Lambda-1a, Peginterferon Alfa-2a, and 2 other interventions for Hepatitis C Virus. Completed, enrolled 881 participants across 104 sites in 15 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus
CountriesAustria, Belgium, Brazil, Canada, Czechia, France, Germany, Israel, Italy, Poland, Russia, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 15, 2012
Enrollment StartJun 14, 2012
Primary CompletionFeb 4, 2015
Study CompletionMay 15, 2015
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 14.1 years ago

Interventions

Peginterferon Lambda-1abiological

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

Peginterferon Alfa-2abiological

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

Ribavirindrug

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

Telaprevirdrug

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