At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 14 enrolled

Drug / intervention

TPV/PEG-IFN/RBVdrug

Likely dose

TPV/PEG-IFN/RBV 1125mgfrom 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/NCT01743521

NCT01743521Phase 4Completed

Compare CT.gov

Direct Acting Antiviral (DAA) Based Therapy for Recently Acquired Hepatitis C

Kirby Institute·interventional·Posted Dec 6, 2012·Updated Mar 29, 2017

In Brief

A Phase 4 clinical trial evaluating TPV/PEG-IFN/RBV for Hepatitis C, Chronic. Completed, enrolled 14 participants across 2 sites.

Detailed Summary

To examine the safety and efficacy of response guided triple therapy (PEG-IFN, Ribavirin, Telaprevir) for the treatment of early chronic Hepatitis C Virus (HCV) infection.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHepatitis C, Chronic

CountriesAustralia

CollaboratorsJanssen-Cilag Ltd.

Timeline

Phase 4CompletedFinished

20132014201520162017201820192020202120222023202420252026

First PostedDec 2012

Enrollment StartJan 2013

Primary CompletionNov 2015

Study CompletionJan 2016

TodayJul 2026

First PostedDec 6, 2012

Enrollment StartJan 1, 2013

Primary CompletionNov 1, 2015

Study CompletionJan 1, 2016

TodayJul 2, 2026

Enrollment to primary: 2.8 yearsPosted 13.6 years ago

Interventions

TPV/PEG-IFN/RBVdrug

Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily. Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing \<75kg and 1200mg for patients weighing ≥ 75kg). Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly.