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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV
ClinicalTrials.gov Identifier:
NCT01498068
First received: December 6, 2011
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Genotype 1 Chronic Hepatitis C
Drug: Telaprevir
Drug: Pegylated-interferon-alfa-2a
Drug: Ribavirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label, Bridging Study to Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Treatment- Naïve and Treatment-Experienced Russian Subjects With Genotype 1 Chronic Hepatitis C

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag International NV:

Primary Outcome Measures:
  • Number of Participants With Extended Rapid Virologic Response (eRVR) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Median Change in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) [ Time Frame: Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 32, Week 40, and Week 48 ] [ Designated as safety issue: No ]
    Changes from baseline in log10 HCV RNA levels were calculated.

  • Number of Participants With Rapid Virologic Response (RVR) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    A RVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at 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. [ Time Frame: Weeks 8, 12, 24, 32, 40 and 48 ] [ Designated as safety issue: No ]
    The table below shows number of participants with HCV RNA Less than 25 IU/mL, (target not detected) at Weeks 8, 12, 24, 32, 40 and 48. Only 3 treatment-naïve and 14 treatment-experienced participants were assigned to receive study treatment after Week 24.

  • Number of Participants With Virologic Failure [ Time Frame: Week 4, Week 8, Week 12, Week 24, Week 32, or Week 40 ] [ Designated as safety issue: No ]
    Virologic failure is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels more than 1,000 IU/mL at Weeks 4, 8, 12, 24, 32, or 40.

  • Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After Last Planned Dose of Study Medication (Week 60) [ Time Frame: Week 60 ] [ Designated as safety issue: No ]
    SVR 12 is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) <25 IU/mL (target not detected) 12 weeks after the last planned dose of study medication.

  • Number of Participants With Relapse [ Time Frame: Week 24 or Week 48 ] [ Designated as safety issue: No ]
    Participants with relapse is defined as having HCV RNA =>25 IU/mL during the follow-up period after previous HCV RNA <25 IU/mL at planned end of treatment [Week 24 or Week 48] and participant did not achieve SVR12planned.

  • Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL at Actual End of Treatment and Never HCV RNA =>25 IU/mL Thereafter [ Time Frame: Week 24 or Week 48 ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: January 2012
Study Completion Date: March 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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
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
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.
Experimental: 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.
Drug: 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
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
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498068

Locations
Russian Federation
Moscow, Russian Federation
Saint-Petersburg, Russian Federation
Samara, Russian Federation
Smolensk, Russian Federation
Stavropol, Russian Federation
Sponsors and Collaborators
Janssen-Cilag International NV
Investigators
Study Director: Janssen-Cilag International NV, Belgium Clinical Trial Janssen-Cilag International NV
  More Information

No publications provided

Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT01498068     History of Changes
Other Study ID Numbers: CR100676, VX-950HPC3007
Study First Received: December 6, 2011
Results First Received: September 11, 2013
Last Updated: March 24, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Janssen-Cilag International NV:
Genotype 1 chronic Hepatitis C
VX-950HPC3007
VX-950
Hepatitis C
Telaprevir
HCV

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Interferon-alpha
Peginterferon alfa-2a
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 15, 2014