An Exploratory Study of Telaprevir in Treatment-Naive Participants With Chronic Genotype 4 Hepatitis C Virus Infection

Tibotec Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Hepatitis C

Treatments: Drug: Ribavirin; Drug: Pegylated-interferon-alfa-2a; Drug: Telaprevir; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00580801

CR013714

VX-950-TiDP24-C210

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

24 participants in 3 patient groups

Telaprevir and then Pegylated-interferon-alfa-2a+Ribavirin

Experimental group

Description:

Telaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection \[injected under the skin by way of a needle\], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 2 to 50.

Treatment:

Drug: Pegylated-interferon-alfa-2a

Drug: Telaprevir

Drug: Ribavirin

Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin

Experimental group

Description:

Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily), from Week 1 to 48.

Treatment:

Drug: Pegylated-interferon-alfa-2a

Drug: Telaprevir

Drug: Ribavirin

Placebo+Pegylated-interferon-alfa-2a+Ribavirin

Active Comparator group

Description:

Matching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks along with pegylated-interferon-alfa 2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily), from Week 1 to 48.

Treatment:

Drug: Pegylated-interferon-alfa-2a

Drug: Ribavirin

Drug: Placebo