Clinical trial NCT00561015: A Phase 2a Study to Evaluate Viral Kinetics and Safety of Telaprevir in Participants With Genotype 2 or 3 Hepatitis C Infection
Official title: A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-Naive Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C, Chronic
Genotype 2
Genotype 3
Telaprevir
Lead sponsor: Tibotec BVBA
Sponsor class: INDUSTRY
First posted: 2007-11-20
Enrollment: 52
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 assess the effect of telaprevir on early hepatitis (inflammation of the liver) C virus (HCV) viral kinetics in treatment-naive participants who are chronically (lasting a long time) infected with genotype 2 or 3 HCV.

Detailed description: This is a Phase 2a multicenter (when more than one hospital or medical school team work on a medical research study), partially blinded, randomized (study drug assigned by chance) stratified (arrange in groups for analysis of results e.g., stratify by age, sex, etc.) for genotype, multiple dose study. The trial will consist of Screening period (6 weeks), Treatment period (24 or 26 weeks) and Follow-up period (24 weeks). The Treatment period will include 2 weeks investigational treatment phase and a 24 week standard treatment phase. All the eligible participants who were never treated for HCV will be enrolled for the trial and will receive the investigational treatment regimen to which they have been randomly assigned for 2 weeks. After this in the standard treatment phase participants will receive the standard treatment of care consisting of pegylated interferon (Peg-IFN)-alfa-2a 180 microgram once weekly and ribavirin (RBV) 400 milligram twice per day. Efficacy will primarily be evaluated by HCV viral load quantification. Participant's safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Participants chronically infected with genotype 2 or 3 hepatitis C virus (HCV) with amount of virus in the blood greater than 10,000 international units per milliliter (IU/ml)
* Participants who were never treated for hepatitis C virus infection
* Participants without any significant lab abnormalities
* Participants who agree to the use of two effective methods of contraception
* Participant who were judged to be in good health

Exclusion Criteria:

* Participants who had contraindications for starting anti-HCV therapy
* Participants who had 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 or hepatocellular carcinoma (type of cancer)
* Participant infected with human immunodeficiency virus (a life-threatening infection that you can get from an infected person's blood or from having sex with an infected person) or hepatitis B virus
* Females who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding
* Participants who have hypersensitivity to tartrazine

Primary outcomes:
measure: Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15
timeFrame: Baseline, Pre-dose (Day 15)
measure: Maximum Plasma Concentration (Cmax) for Telaprevir on Day 1
timeFrame: Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hour [hr])
measure: Time to Reach Maximum Plasma Concentration (Tmax) for Telaprevir on Day 1
timeFrame: Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)
measure: Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 1
timeFrame: Pre-dose Day 1 (0.5, 1, 2, 3, 4, 6, 8 hr)
Secondary outcomes:
measure: Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 15
timeFrame: Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)
measure: Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26
timeFrame: Baseline and Week 24/26
measure: Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15
timeFrame: Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)
measure: Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15
timeFrame: Pre-dose Day 15 (0.5, 1, 2, 3, 4, 6, 8 hr)
measure: Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml)
timeFrame: Baseline, Day 12, 15, Week 4, 6, 14 and EOT (Week 24/26 or early discontinuation)
measure: Median Time to Virological Response (HCV RNA Level < 10 IU/ml)
timeFrame: Baseline up to EOT
measure: Percentage of Participants With Viral Breakthrough
timeFrame: Baseline, Day 12, 15 and Week 24/26
measure: Percentage of Participants Who Demonstrated Virological Relapse
timeFrame: 24 weeks after EOT
measure: Percentage of Participants Who Achieved Sustained Virological Response (SVR)
timeFrame: Week 12, 24 after EOT
Other outcomes:
Locations:
city: Clichy
country: France
city: Creteil N/A
country: France
city: Lyon
country: France
city: Paris
country: France
city: Vandoeuvre Les Nancy
country: France
city: Stockholm
country: Sweden
city: London
country: United Kingdom
Study officials:
affiliation: Tibotec BVBA
name: Tibotec-Virco Virology BVBA Clinical Trial
role: STUDY_DIRECTOR
References: