Clinical trial NCT00528528: 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
Official title: A Phase IIa Randomized, Open-Label Study of Telaprevir (VX-950) Administered Every 12 or Every 8 Hours in Combination With Either Peg-IFN alfa2a (Pegasys) and Ribavirin (Copegus) or Peg-IFN alfa2b (PegIntron) and Ribavirin (Rebetol) in Treatment-Naive Subjects With Chronic Genotype 1 Hepatitis C Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Keywords: Chronic Hepatitis C
Genotype 1
Telaprevir
Treatment-naïve
VX-950-C208
VX-950-TiDP24-C208
Lead sponsor: Tibotec BVBA
Sponsor class: INDUSTRY
First posted: 2007-09-12
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a Phase 2a, open-label (all people know the identity of the intervention), multicenter trial (conducted in more than one center) in participants with chronic genotype 1 HCV infection. The trial consists of a Screening phase of approximately 4 weeks, a treatment phase up to 48 weeks depending on participants' individual virologic response, and a follow-up phase of at least 24 weeks. All participants will receive 12 weeks of telaprevir treatment in combination with standard therapy. At Week 12, telaprevir dosing will end and participants will continue on standard therapy only. Participants will be randomly assigned to receive one of the two different dosage regimens of telaprevir (750 milligram \[mg\] every 8 hours (hr), or 1125 mg every 12 hr) in combination with standard therapy (pegylated interferon \[Peg-IFN\]-alfa-2a and ribavirin \[RBV\] or Peg-IFN-alfa-2b and RBV at the standard doses). Efficacy will be evaluated by HCV Ribonucleic Acid (RNA) values, viral response, viral breakthrough, partial response, early viral kinetics and sustained viral response. Pharmacokinetics, Pharmacokinetic-pharmacodynamic relationship will also be evaluated. Safety will be monitored throughout the study duration.

Eligibility criteria: Inclusion Criteria:

* Chronic genotype 1 Hepatitis (inflammation of the liver) C infection
* Never been treated for Hepatitis C Viral (HCV) infection
* No clinically significant lab abnormalities
* Amount of HCV Ribonucleic acid (RNA) in the blood more than 10,000 international units/milliliter (IU/mL) at entry
* Liver biopsy or "Fibroscan" test performed during screening or in the past 3 years

Exclusion Criteria:

* Contra-indications for starting anti-HCV therapy
* History or evidence of liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs) or decompensated liver disease
* Any evidence of significant liver disease in addition to Hepatitis C
* Infected with Human Immunodeficiency Virus (a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person) or Hepatitis B
* Women who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding or the partner of a woman who is pregnant or breastfeeding

Primary outcomes:
measure: Percentage of Participants With Virologic Response at Week 12
timeFrame: End of treatment (EOT) (up to Week 48)
Secondary outcomes:
measure: Time to First Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level
timeFrame: Baseline (Day 1) up to EOT (up to Week 48)
measure: Number of Participants With Viral Breakthrough at End of Treatment (EOT)
timeFrame: EOT (up to Week 48)
measure: Percentage of Participants With Partial Response
timeFrame: Baseline (Day 1) up to EOT (up to Week 48)
measure: Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at Week 12
timeFrame: Baseline (pre-dose), Week 12
measure: Change From Baseline in Log 10-Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values at End of Treatment (EOT)
timeFrame: Baseline (pre-dose), EOT (up to Week 48)
measure: Percentage of Participants With Sustained Viral Response 24 Weeks After End of Treatment (SVR24)
timeFrame: EOT (up to Week 48) and up to 24 weeks after EOT
Other outcomes:
Locations:
city: Wien
country: Austria
city: Brussels
country: Belgium
city: Bruxelles
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Liège
country: Belgium
city: Angers Cedex 9
country: France
city: Clichy
country: France
city: Grenoble
country: France
city: Lille Cedex
country: France
city: Nice
country: France
city: Paris Cedex 12
country: France
city: Paris
country: France
city: Vandoeuvre Les Nancy
country: France
city: Düsseldorf
country: Germany
city: Frankfurt N/A
country: Germany
city: Freiburg
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Koln
country: Germany
city: Tübingen
country: Germany
city: Leiden
country: Netherlands
city: Nijmegen
country: Netherlands
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
Study officials:
affiliation: Tibotec BVBA
name: Tibotec-Virco Virology BVBA Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Serfaty L, Forns X, Goeser T, Ferenci P, Nevens F, Carosi G, Drenth JP, Lonjon-Domanec I, DeMasi R, Picchio G, Beumont M, Marcellin P. Insulin resistance and response to telaprevir plus peginterferon alpha and ribavirin in treatment-naive patients infected with HCV genotype 1. Gut. 2012 Oct;61(10):1473-80. doi: 10.1136/gutjnl-2011-300749. Epub 2012 Mar 2.