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VX-950-TiDP24-C209: A Phase 2a Partially Blinded Clinical Study to Evaluate the Viral Kinetics and Safety of Telaprevir in Patients With Genotype 2 or 3 Infection.

This study has been completed.
Sponsor:
Information provided by:
Tibotec BVBA
ClinicalTrials.gov Identifier:
NCT00561015
First received: November 19, 2007
Last updated: December 23, 2010
Last verified: December 2010
History of Changes
  Purpose

The purpose of this study is to assess the effect of telaprevir on early HCV viral kinetics in treatment-naÃ-ve patients who are chronically infected with genotype 2 or 3 hepatitis C virus (HCV).


Condition Intervention Phase
Hepatitis C, Chronic
 Drug: Telaprevir
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-na�ve Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection.

Resource links provided by NLM:

Drug Information available for: Telaprevir
U.S. FDA Resources

Further study details as provided by Tibotec BVBA:

Primary Outcome Measures:
  • This is an exploratory study. Viral kinetics, safety and pharmacokinetic/pharmacodynamic relationship will be studied.

Enrollment: 51
Study Start Date: December 2007
Study Completion Date: May 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Detailed Description:

The purpose of this Phase IIa multicenter, partially blinded, randomized (study drug assigned by chance), stratified for genotype, multiple dose study is to assess the effect of telaprevir on HCV early viral kinetics in treatment-naïve patients who are chronically infected with genotype 2 or 3 hepatitis C virus (HCV).

The trial will consist of a screening period of approximately 4 weeks, a treatment period of 26 weeks, and a follow-up period of at least 24 weeks. The treatment period will be made up of a 2-week investigational treatment phase and a 24-week standard treatment phase.

A total of 48 patients who have never been treated for HCV (24 patients infected with HCV genotype 2 and 24 patients infected with HCV genotype 3) will be enrolled in the trial.

All patients will receive the investigational treatment regimen to which they have been randomized for 2 weeks. Subsequently, they will receive 24 weeks of standard treatment consisting of pegylated interferon (Peg-IFN) alfa2a 180 µg once-weekly and ribavirin (RBV) 400 mg twice per day.

Patients will be followed for at least 24 weeks after the end of treatment (EOT; Week 26 or early discontinuation) in order to assess sustained virologic response (SVR24) or to collect samples for viral sequencing.

HCV viral load quantification and safety/tolerability assessments will be performed frequently throughout the trial.

Extensive virologic and pharmacokinetic assessments for pharmacokinetic/pharmacodynamic analysis will be performed during the investigational treatment phase. There are 3 treatment groups in this study, each group will consist of 16 patients, 8 patients genotype 2 and 8 patients genotype 3. Group A. telaprevir 750 mg 3 times/day; B. telaprevir 750 mg 3 times/day + pegylated interferon alfa2a 180 µg once-weekly + ribavirin 400 mg twice per day; C. telaprevir placebo 3 times/day + pegylated interferon alfa2a 180 µg once-weekly + ribavirin 400 mg twice per day. This will be followed by 24 weeks of standard treatment with Peg-IFN and ribavirine.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic genotype 2 or 3 hepatitis C infection with amount of virus in the blood >10.000IU/ml
  • Never been treated for HCV infection
  • No significant lab abnormalities
  • Agree to the use of two effective methods of contraception
  • Patient judged to be in good health
  • Patient signed ICF voluntarily

Exclusion Criteria:

  • No contra-indications for starting anti-HCV therapy
  • No history or evidence of liver cirrhosis or decompensated liver disease or hapatocellular carcinoma
  • Not infected with HIV or Hepatitis B
  • Not pregnant, planning to be pregnant or breastfeeding or not the partner of a woman who is pregnant or breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561015

Sponsors and Collaborators
Tibotec BVBA
Investigators
Study Director: Tibotec-Virco Virology BVBA Clinical Trial Tibotec BVBA
  More Information

No publications provided

Responsible Party: Compound Development Team Leader VX-950, Tibotec Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT00561015     History of Changes
Obsolete Identifiers: NCT00613704
Other Study ID Numbers: CR013513
Study First Received: November 19, 2007
Last Updated: December 23, 2010
Health Authority: USA: FOOD AND DRUG ADMINISTRATION - CENTER FOR DRUG EVALUATION AND RESEARCH

Keywords provided by Tibotec BVBA:
Chronic Hepatitis C
Genotype 2 and 3
Telaprevir
 Treatment-naïve
VX-950-TiDP24-C209
VX-950-C209

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic

ClinicalTrials.gov processed this record on May 16, 2013