At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 20 enrolled

Drug / intervention

Telaprevir and Sofosbuvirdrug

Likely dose

Not stated in 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/NCT01994486

NCT01994486Phase 2Completed

Compare CT.gov

Open-Label Study to Evaluate the Safety and Tolerability of Telaprevir in Combination With Sofosbuvir in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotype 1

University of Florida·interventional·Posted Nov 25, 2013·Updated Apr 23, 2018

In Brief

A Phase 2 clinical trial evaluating Telaprevir and Sofosbuvir for Hepatitis C, Chronic. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This is an open-label, multi center study of treatment-naive non-cirrhotic subjects with genotype 1 chronic Hepatitis C Virus. All subjects will receive telaprevir (TVR) in combination with sofosbuvir (SOF) for 12 weeks.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHepatitis C, Chronic

CountriesUnited States

CollaboratorsVertex Pharmaceuticals Incorporated

Timeline

Phase 2CompletedFinished

2014201520162017201820192020202120222023202420252026

First PostedNov 2013

Enrollment StartDec 2013

Primary CompletionApr 2014

Study CompletionSep 2014

TodayJul 2026

First PostedNov 25, 2013

Enrollment StartDec 1, 2013

Primary CompletionApr 1, 2014

Study CompletionSep 1, 2014

TodayJul 2, 2026

Enrollment to primary: 4 monthsPosted 12.6 years ago

Interventions

Telaprevir and Sofosbuvirdrug

All subjects will have time to read and discuss IRB approved consent form prior to any study procedures. Following proper consenting, subjects will undergo physical exam including ECG and bloodwork prior to baseline visit. Subjects will return for research visits (vitals, collection of AEs, bloodwork, drug accountability) on Day 3, Weeks 1, 2, 3, 4, 6, 8, 10 and 12 of treatment and 4, 12, and 24 weeks after end of treatment. PK samples will be collected at week 2 and week 10.