CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 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/NCT00892697
NCT00892697Phase 2Completed
CompareCT.gov

#0810010040: Intrahepatic HCV RNA and Telaprevir Kinetics in Hepatitis C Virus Infection: A Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects With Hepatitis C

Weill Medical College of Cornell University·interventional·Posted May 4, 2009·Updated Mar 20, 2015

In Brief

A Phase 2 clinical trial evaluating Telaprevir, Peginterferon alfa-2a, and 1 other intervention for Hepatitis C. Completed, enrolled 15 participants.

Detailed Summary

The purpose of this study is to determine the decline of virus in the blood and liver in patients treated with telaprevir, pegylated interferon and ribavirin. Fine Needle Aspiration (FNA) procedure will be used to repeatedly sample the liver to enhance the understanding of how the virus decays in the liver in response to treatment with anti-viral compounds and the measurement of the concentration of the drugs in the liver. FNA is an alternative procedure to core needle biopsy in its ability to repeatedly sample the liver with significantly reduced morbidity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
Countries--
CollaboratorsVertex Pharmaceuticals Incorporated

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 4, 2009
Enrollment StartMay 1, 2009
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 17.2 years ago

Interventions

Telaprevirdrug

Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if \>75 kg or 1000mg per day if \< 75 kg).

Peginterferon alfa-2adrug

Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if \>75 kg or 1000mg per day if \< 75 kg).

Ribavirindrug

Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if \>75 kg or 1000mg per day if \< 75 kg).