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Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C

NCT ID: NCT01498068

Last Updated: 2015-01-30

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-03-31

Brief Summary

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The purpose of this study is to determine the effectiveness, safety and tolerability of telaprevir administered as 750 mg every 8 hours (q8h) in combination with pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in treatment-naïve and treatment-experienced Russian participants with genotype 1 chronic hepatitis C.

Detailed Description

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This is an open-label (all persons know the study drug assignment), multicenter study in treatment-naïve (participant did not receive any previous treatment for the treatment of hepatitis C) and treatment-experienced (participant did receive previous treatment for hepatitis C) Russian participants with genotype 1 chronic hepatitis C. After a screening period of approximately 4 weeks, participants will be treated for 12 weeks with telaprevir 750 mg every 8 hours in combination with Peg-IFN-alfa-2a and RBV followed by 12 or 36 weeks of treatment with Peg-IFN-alfa-2a and RBV alone depending on their liver disease status, response to previous treatment and individual virologic response during treatment in this study. After the treatment period, there is a follow-up phase of at least 12 weeks.

Conditions

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Genotype 1 Chronic Hepatitis C

Keywords

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Genotype 1 chronic Hepatitis C VX-950HPC3007 VX-950 Hepatitis C Telaprevir HCV

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment-naïve

Treatment naïve participants will receive telaprevir 750 mg 8 hourly for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram weekly and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration will be based on participant's prior treatment status, liver disease status, and individual ontreatment virologic response in this study.

Group Type EXPERIMENTAL

Telaprevir

Intervention Type DRUG

Telaprevir Type = exact number, unit = mg, number = 750, form = tablet, route = oral. Telaprevir 750 mg (2 oral tablets) is taken every 8 hours for 12 weeks

Pegylated-interferon-alfa-2a

Intervention Type DRUG

Pegylated-interferon-alfa-2a type = exact number, unit = microgram, number = 180, form = injection, route = subcutaneous. 180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks

Ribavirin

Intervention Type DRUG

Ribavirin Type = exact, number = 1000 or 1200, unit = mg, form = tablet, route = oral. 1000mg (if participant's weight is \< 75kg) or 1200mg (if participant's weight is \>= 75kg) per day for 24 or 48 weeks.

Treatment-experienced

Treatment-experienced participants received telaprevir 750 mg 8 hourly for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram weekly and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration will be based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.

Group Type EXPERIMENTAL

Telaprevir

Intervention Type DRUG

Telaprevir Type = exact number, unit = mg, number = 750, form = tablet, route = oral. Telaprevir 750 mg (2 oral tablets) is taken every 8 hours for 12 weeks

Pegylated-interferon-alfa-2a

Intervention Type DRUG

Pegylated-interferon-alfa-2a type = exact number, unit = microgram, number = 180, form = injection, route = subcutaneous. 180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks

Ribavirin

Intervention Type DRUG

Ribavirin Type = exact, number = 1000 or 1200, unit = mg, form = tablet, route = oral. 1000mg (if participant's weight is \< 75kg) or 1200mg (if participant's weight is \>= 75kg) per day for 24 or 48 weeks.

Interventions

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Telaprevir

Telaprevir Type = exact number, unit = mg, number = 750, form = tablet, route = oral. Telaprevir 750 mg (2 oral tablets) is taken every 8 hours for 12 weeks

Intervention Type DRUG

Pegylated-interferon-alfa-2a

Pegylated-interferon-alfa-2a type = exact number, unit = microgram, number = 180, form = injection, route = subcutaneous. 180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks

Intervention Type DRUG

Ribavirin

Ribavirin Type = exact, number = 1000 or 1200, unit = mg, form = tablet, route = oral. 1000mg (if participant's weight is \< 75kg) or 1200mg (if participant's weight is \>= 75kg) per day for 24 or 48 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participant has genotype 1 chronic hepatitis C with HCV RNA level \>1000 IU/mL
* Participant is either treatment-naïve and did not receive any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C, or participant is treatment-experienced who did not achieve sustained virologic response (SVR) 24 weeks after at least 1 prior course of Peg-IFN/RBV therapy (null-responder, partial-responder or viral relapse)
* Participant must have documentation of liver biopsy or fibroscan within 2 years before the screening visit or agree to have a biopsy or fibroscan within the screening period unless histological cirrhosis was demonstrated by a biopsy or fibroscan \> 2 years ago prior to screening
* A female participant of childbearing potential and a nonvasectomized male participant who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female participant ) or 7 months (male participant) after the last dose of RBV

Exclusion Criteria

* Prior non-responder that is classified as a viral breakthrough participant
* Participant is infected or co-infected with HCV of another genotype than genotype 1
* Participant has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
* Participant has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
* Participant has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma or hepatocellular carcinoma
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen-Cilag International NV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen-Cilag International NV, Belgium Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag International NV

Locations

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Moscow, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Samara, , Russia

Site Status

Smolensk, , Russia

Site Status

Stavropol, , Russia

Site Status

Countries

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Russia

Other Identifiers

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VX-950HPC3007

Identifier Type: OTHER

Identifier Source: secondary_id

CR100676

Identifier Type: -

Identifier Source: org_study_id