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

NCT01498068 | Completed Phase 3 Results

• 2 other identifiers: CR100676VX-950HPC3007
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Genotype 1 Chronic Hepatitis C

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Extended Rapid Virologic Response (eRVR)

  A eRVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at Weeks 4 and 12 of treatment.

  Week 4 and Week 12

Secondary Outcomes (5)

• Median Change in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)

  Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 32, Week 40, and Week 48

• Number of Participants With Rapid Virologic Response (RVR) at Week 4

  Week 4

• Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Less Than 25 IU/mL, (Target Not Detected) at Weeks 8, 12, 24, 32, 40 and 48

  Weeks 8, 12, 24, 32, 40 and 48

• Number of Participants With Virologic Failure

  Week 4, Week 8, Week 12, Week 24, Week 32, or Week 40

• Number of Participants in Each Specific Category of Treatment Outcome

  From Day 1 (Baseline) up to Follow-up visit (Week 36 or Week 60)

Study Arms (2)

Treatment-naïve

EXPERIMENTAL

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.

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

Treatment-experienced

EXPERIMENTAL

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.

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

Interventions

Telaprevir 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

Treatment-experienced; Treatment-naïve

Pegylated-interferon-alfa-2a 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

Treatment-experienced; Treatment-naïve

Ribavirin 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-naïve

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag International NV: lead

Study Sites (5)

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Samara, Russia

Location

Unknown Facility

Smolensk, Russia

Location

Unknown Facility

Stavropol, Russia

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

telaprevir; peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Compound Development Team Leader
• Organization: Janssen Belgium

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Study Officials

• Janssen-Cilag International NV, Belgium Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: December 23, 2011
• Study Start: January 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: March 1, 2013
• Last Updated: January 30, 2015
• Results First Posted: December 30, 2013

Record last verified: 2015-01

Locations

RU (5)