MedTrace Logo

An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants

NCT00528528 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2014-06-25

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), and pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different doses in combination with two standard therapies commercially available for chronic (lasting a long time) genotype 1 Hepatitis (inflammation of the liver) C virus (HCV) infection.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

Telaprevir

Oval tablets containing 375 mg of telaprevir for oral administration.

DRUG

Peg-IFN-alfa-2a

Solution containing Peg-IFN alfa2a for subcutaneous injection in a pre-filled syringe.

DRUG

Peg-IFN-alfa-2b

Powder containing Peg-IFN-alfa-2b and solvent for solution for subcutaneous injection in a pre-filled pen.

DRUG

Ribavirin (RBV) tablet

Tablets containing 200 mg RBV for oral administration.

DRUG

Ribavirin (RBV) capsule

Capsules containing 200 mg RBV for oral administration.

Sponsors & Collaborators

  • Tibotec BVBA

    lead INDUSTRY

Principal Investigators

  • Tibotec-Virco Virology BVBA Clinical Trial · Tibotec BVBA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-07-31
Completion
2009-08-31

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Netherlands
  • Spain

Study Locations

More Related Trials

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 NCT00528528 on ClinicalTrials.gov