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

NCT ID: NCT00580801

Last Updated: 2013-09-09

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-01-31

Brief Summary

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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

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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.

Conditions

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Hepatitis C

Keywords

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Hepatitis C Telaprevir Pegylated-interferon-alfa-2a Pegasys Ribavirin Copegus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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

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.

Group Type EXPERIMENTAL

Telaprevir

Intervention Type DRUG

Telaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks.

Pegylated-interferon-alfa-2a

Intervention Type DRUG

Pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection, once weekly) will be administered from Week 1 to Week 48 or 50.

Ribavirin

Intervention Type DRUG

Ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 1 to Week 48 or 50.

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

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.

Group Type EXPERIMENTAL

Telaprevir

Intervention Type DRUG

Telaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks.

Pegylated-interferon-alfa-2a

Intervention Type DRUG

Pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection, once weekly) will be administered from Week 1 to Week 48 or 50.

Ribavirin

Intervention Type DRUG

Ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 1 to Week 48 or 50.

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

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.

Group Type ACTIVE_COMPARATOR

Pegylated-interferon-alfa-2a

Intervention Type DRUG

Pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection, once weekly) will be administered from Week 1 to Week 48 or 50.

Placebo

Intervention Type DRUG

Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks.

Ribavirin

Intervention Type DRUG

Ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 1 to Week 48 or 50.

Interventions

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Telaprevir

Telaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks.

Intervention Type DRUG

Pegylated-interferon-alfa-2a

Pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection, once weekly) will be administered from Week 1 to Week 48 or 50.

Intervention Type DRUG

Placebo

Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks.

Intervention Type DRUG

Ribavirin

Ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 1 to Week 48 or 50.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tibotec BVBA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tibotec-Virco Virology BVBA Clinical Trial

Role: STUDY_DIRECTOR

Tibotec BVBA

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 24886541 (View on PubMed)

Other Identifiers

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VX-950-TiDP24-C210

Identifier Type: -

Identifier Source: secondary_id

CR013714

Identifier Type: -

Identifier Source: org_study_id

NCT00614237

Identifier Type: -

Identifier Source: nct_alias