Clinical trial NCT00580801: An Exploratory Study of Telaprevir in Treatment-Naive Participants With Chronic Genotype 4 Hepatitis C Virus Infection
Official title: A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-Naive Subjects With Chronic Genotype 4 Hepatitis C Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Keywords: Hepatitis C
Telaprevir
Pegylated-interferon-alfa-2a
Pegasys
Ribavirin
Copegus
Lead sponsor: Tibotec BVBA
Sponsor class: INDUSTRY
First posted: 2007-12-27
Enrollment: 24
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 evaluate the activity and safety of telaprevir on Hepatitis C Virus (HCV) Genotype 4, alone or in combination with standard therapy, that is, pegylated-interferon-alfa-2a and ribavirin in treatment-naive (never been treated before with antiretroviral therapy) participants.

Detailed description: This is a Phase 2a, partially-blind, randomized (study drug assigned by chance) and multiple-dose study to evaluate the activity and safety of telaprevir on HCV early viral kinetics in treatment-naive participants who are chronically infected with HCV Genotype 4. The study consists of 4 parts: Screening period (6-week); Investigational Treatment period (consisting of 2-week treatment with telaprevir or telaprevir+standard treatment or placebo); Standard Treatment period (consists of 46 or 48-week standard treatment); and Follow-up period (24-week). The activity of telaprevir will be evaluated by early viral kinetic parameters along with viral response and pharmacokinetic assessments during the investigational treatment phase. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria: - Participant has chronic Genotype 4 Hepatitis C infection

* Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level greater than 10,000 International unit per milliliter (IU/mL) at Screening
* Participant never received treatment for HCV
* Participant was to be in good health (besides HCV infection), in the opinion of the Investigator, judged on the basis of medical history and physical examination (including vital signs and screening electrocardiogram \[ECG\]), with any chronic medical conditions under stable medical control
* Participant had to be willing to refrain from the concomitant use of any medications or substances Exclusion Criteria: - Participants with history or evidence of cirrhosis or history of suspicion of alcohol, barbiturate, or amphetamine recreational or narcotic drug use, which in the Investigator's opinion would compromise the participant's safety and/or compliance with study procedures
* Participant has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
* Female participants who are pregnant, or planning to become pregnant, or breastfeeding, and partners of female participants who are pregnant or breastfeeding
* Participant has hypersensitivity to tartrazine
* Participant had participated in any clinical trial for an investigational drug within 90 days before drug administration or participated in more than 2 drug studies in the last 12 months

Primary outcomes:
measure: Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Day 15
timeFrame: Baseline and Day 15
Secondary outcomes:
measure: Percentage of Participants With Viral Response (Undetectable HCV RNA)
timeFrame: Day 15 up to EOT (Week 48/50 or early discontinuation)
measure: Median Time to First Viral Response (Undetectable HCV RNA)
timeFrame: Up to Week 48/50
measure: Number of Participants With Viral Breakthrough (Detectable HCV RNA)
timeFrame: Day 8, Day 12, Day 15, Week 24/26 and Week 36/38
measure: Percentage of Participants With Sustained Viral Response (SVR)
timeFrame: Week 12 and 24 after the last dose of study medication
measure: Percentage of Participants With Relapse
timeFrame: Week 24 after EOT (Week 48/50 or early discontinuation)
measure: Area Under the Serum Concentration-Time Curve (AUC)
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15
measure: Maximum Serum Concentration (Cmax) of Telaprevir
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15
measure: Pre-Dose Serum Concentration (C[0h]) of Telaprevir
timeFrame: 0 hour (pre-dose) at Day 15
measure: Minimum Serum Concentration (Cmin) of Telaprevir on Day 15
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 15
measure: Time to Reach the Maximum Serum Concentration (Tmax) of Telaprevir
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15
measure: Average Steady-State Serum Concentration (Css,av) of Telaprevir
timeFrame: Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 hours post-dose on Day 1 and 15
Other outcomes:
Locations:
Study officials:
affiliation: Tibotec BVBA
name: Tibotec-Virco Virology BVBA Clinical Trial
role: STUDY_DIRECTOR
References:
citation: De Meyer S, Ghys A, Dierynck I, Beumont M, Luo D, Picchio G. Virologic characterization of genotype 4 hepatitis C virus variants in patients treated with telaprevir. Virol J. 2014 May 16;11:93. doi: 10.1186/1743-422X-11-93.