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A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)

NCT00627926 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1095

Last updated 2014-08-08

Study results available
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Summary

A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).

Conditions

  • Hepatitis C

Interventions

BIOLOGICAL

Pegylated Interferon Alfa 2a

subcutaneous injection, 180 micrograms once per week

DRUG

Telaprevir

375 mg tablets administered orally every 8 hours at a dose of 750 mg

DRUG

Ribavirin

200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing ≥75 kg

OTHER

Placebo

Telaprevir matching placebo

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Vertex Pharmaceuticals Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Canada
  • France
  • Germany
  • Israel
  • Italy
  • Poland
  • Puerto Rico
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00627926 on ClinicalTrials.gov