CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 36 enrolled
Drug / intervention
Telaprevir +2 moredrug
Likely dose
Telaprevir 750 mgfrom 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/NCT01498068
NCT01498068Phase 3Completed
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Open-Label, Bridging Study to Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Treatment- Naïve and Treatment-Experienced Russian Subjects With Genotype 1 Chronic Hepatitis C

Janssen-Cilag International NV·interventional·Posted Dec 23, 2011·Updated Jan 30, 2015

In Brief

A Phase 3 clinical trial evaluating Telaprevir, Pegylated-interferon-alfa-2a, and 1 other intervention for Genotype 1 Chronic Hepatitis C. Completed, enrolled 36 participants across 5 sites.

Detailed Summary

The purpose of this study is to determine the effectiveness, safety and tolerability of telaprevir administered as 750 mg every 8 hours (q8h) in combination with pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in treatment-naïve and treatment-experienced Russian participants with genotype 1 chronic hepatitis C.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGenotype 1 Chronic Hepatitis C
CountriesRussia
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 23, 2011
Enrollment StartJan 1, 2012
Primary CompletionApr 1, 2012
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 14.5 years ago

Interventions

Telaprevirdrug

Telaprevir Type = exact number, unit = mg, number = 750, form = tablet, route = oral. Telaprevir 750 mg (2 oral tablets) is taken every 8 hours for 12 weeks

Pegylated-interferon-alfa-2adrug

Pegylated-interferon-alfa-2a type = exact number, unit = microgram, number = 180, form = injection, route = subcutaneous. 180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks

Ribavirindrug

Ribavirin Type = exact, number = 1000 or 1200, unit = mg, form = tablet, route = oral. 1000mg (if participant's weight is \< 75kg) or 1200mg (if participant's weight is \>= 75kg) per day for 24 or 48 weeks.