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A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response

NCT00758043 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2021-03-26

Study results available
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Summary

This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who respond quickly to a telaprevir-based treatment.

Conditions

  • Hepatitis C

Interventions

DRUG

telaprevir

750 mg every 8 hours (q8h) for 12 weeks

DRUG

ribavirin

1000 - 1200 mg/day based on body weight for either 24 or 48 weeks

BIOLOGICAL

peginterferon alfa-2a

180 mcg/week for either 24 or 48 weeks

Sponsors & Collaborators

Principal Investigators

  • Michael Adler, MD, PhD · Erasmus Hospital Bruxelles

  • Hendrik Reesink, MD, PhD · Academic Medical Center of the University of Amsterdam

  • Kenneth Sherman, MD, PhD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-06-30
Completion
2010-07-31

Countries

  • United States
  • Belgium
  • Netherlands
  • Puerto Rico

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 NCT00758043 on ClinicalTrials.gov