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A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment

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ClinicalTrials.gov Identifier: NCT00703118
Recruitment Status : Completed
First Posted : June 23, 2008
Results First Posted : August 11, 2011
Last Update Posted : January 22, 2014
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
Tibotec BVBA

Study Description
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Brief Summary:
The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: Telaprevir Drug: Peg-IFN-alfa-2a Drug: Ribavirin Drug: Placebo Phase 3

Detailed Description:
This is a randomized, double-blind, placebo-controlled Phase III trial with telaprevir in patients with chronic Hepatitis C Virus (HCV), genotype 1, infection who failed prior treatment with standard treatment. Standard treatment is defined as treatment with Peg-INF and RBV. The trial is designed to compare the efficacy, safety, and tolerability of 2 regimens of telaprevir (with and without delayed start) combined with standard treatment versus standard treatment alone. The trial will consist of a screening period of approximately 4 weeks, a 48-week treatment period, and a 24-week follow-up period. Patients will be eligible to enroll in the trial if they (1) had an undetectable HCV Ribonucleic Acid (RNA) level at the end of a prior course of standard treatment but did not achieve a response (viral relapsers), or (2) never had an undetectable HCV RNA level during or at the end of a prior course of standard treatment (non-responders). Approximately 650 patients (350 prior relapsers and 300 prior non-responders) will be randomized in a 2:2:1 ratio to one of 3 treatment groups: Treatment group A will receive telaprevir with standard treatment for 12 weeks; followed by placebo with standard treatment for 4 weeks; followed by standard treatment for 32 weeks. Treatment group B will receive placebo with standard treatment for 4 weeks; followed by telaprevir with standard treatment for 12 weeks; followed by standard treatment for 32 weeks. Treatment group C will receive placebo with standard treatment for 16 weeks; followed by standard treatment for 32 weeks. In both telaprevir regimens (A and B), patients will receive 12 weeks of 750 mg of telaprevir every 8 hours along with 48 weeks of standard treatment. Telaprevir or placebo will be given by mouth at a dose of 750 mg every 8 hours for 16 weeks. Peg-INF will be given as an injection under the skin at a dose of 180 mcg once every week for 48 weeks. RBV will be given by mouth at a dose of either 1000 or 1200 mg (depending on your body weight) two times per day for 48 weeks.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 663 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of 2 Regimens of Telaprevir (With and Without Delayed Start) Combined With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Subjects With Chronic, Genotype 1, Hepatitis C Infection Who Failed Prior Standard Treatment
Study Start Date : October 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A: T12/PR48
Participants will receive 12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses.
 Drug: Telaprevir
Participants will receive telaprevir tablets of 750 mg orally eight hourly for 12 weeks in group A and B.

Drug: Peg-IFN-alfa-2a
Participants will receive 180 µg subcutaneous (under the skin) injection of Peg-IFN-alfa-2a once weekly for 48 weeks in Group A, B and C.

Drug: Ribavirin
Participants will receive ribavirin tablets of 1000-1200 mg orally twice daily for 48 weeks in Group A, B, and C.

Drug: Placebo
Participants will receive telaprevir matching placebo tablets orally for 4 weeks in Group A and B. Participants will receive telaprevir matching placebo tablets orally for 16 weeks in Group C.
Experimental: Group B: T12(DS)/PR48
Participants will receive 4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses.
 Drug: Telaprevir
Participants will receive telaprevir tablets of 750 mg orally eight hourly for 12 weeks in group A and B.

Drug: Peg-IFN-alfa-2a
Participants will receive 180 µg subcutaneous (under the skin) injection of Peg-IFN-alfa-2a once weekly for 48 weeks in Group A, B and C.

Drug: Ribavirin
Participants will receive ribavirin tablets of 1000-1200 mg orally twice daily for 48 weeks in Group A, B, and C.

Drug: Placebo
Participants will receive telaprevir matching placebo tablets orally for 4 weeks in Group A and B. Participants will receive telaprevir matching placebo tablets orally for 16 weeks in Group C.
Experimental: Group C: Pbo/PR48
Participants will receive placebo in combination with Peg- IFN-alfa-2a and ribavirin for 16 weeks. Participants will receive Peg- IFN-alfa-2a and ribavirin for next 32 weeks.
 Drug: Peg-IFN-alfa-2a
Participants will receive 180 µg subcutaneous (under the skin) injection of Peg-IFN-alfa-2a once weekly for 48 weeks in Group A, B and C.

Drug: Ribavirin
Participants will receive ribavirin tablets of 1000-1200 mg orally twice daily for 48 weeks in Group A, B, and C.

Drug: Placebo
Participants will receive telaprevir matching placebo tablets orally for 4 weeks in Group A and B. Participants will receive telaprevir matching placebo tablets orally for 16 weeks in Group C.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned [ Time Frame: Week 72 ]
    SVR24 planned is defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after the last planned dose of study medication.


Secondary Outcome Measures :
  1. Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4 [ Time Frame: Week 4 ]
    RVR was defined as having undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4.

  2. Number of Participants Acheiving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 48 (End of Treatment) [ Time Frame: Week 48 ]
  3. Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Medication - SVR12 Planned [ Time Frame: Week 60 ]
    SVR12 planned was defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks after the last planned dose of study medication (SVR12 planned).

  4. Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8 [ Time Frame: Week 4, Week 6, or Week 8 ]
    Telaprevir stopping rule is defined as having Hepatitis C virus (HCV) ribonucleic acid (RNA) levels >100 IU/mL at Week 4, Week 6, or Week 8 after start of telaprevir.

  5. Number of Participants Who Have Viral Relapse During Entire Follow-up Period (up to Week 72) [ Time Frame: Up to Week 72 ]
    Viral relapse was defined as having confirmed detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels during entire follow-up period (up to Week 72).

  6. Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 [ Time Frame: Baseline (Day 1) to Week 4 ]
  7. Number of Participants Acheiving Extended Rapid Virologic Response at Week 4 and Week 12 [ Time Frame: Week 4 and Week 12 ]
    Extended rapid virologic response was defined as undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must have chronic hepatitis C infection (genotype 1) with HCV RNA level >= 1000 IU/mL
  • Patient must have failed at least 1 prior course of Peg-IFN/RBV therapy (standard treatment)
  • Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication

Exclusion Criteria:

  • Patient is a previous non-responder that is classified as a viral breakthrough case
  • Patient is infected with Hepatitis C virus, genotype 1, exhibiting more than one subtype
  • Patient has Hepatitis C virus, genotype 1, and exhibits co-infection with any other genotype
  • Evidence of decompensated liver disease
  • Patient has condition that requires use of systemic corticosteroids
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703118


Locations
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Sponsors and Collaborators
Tibotec BVBA
Tibotec Pharmaceutical Limited
Investigators
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Study Director: Tibotec-Virco Virology BVBA Clinical Trial Tibotec BVBA
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tibotec BVBA
ClinicalTrials.gov Identifier: NCT00703118    
Other Study ID Numbers: CR014842
VX-950-TIDP24-C216 ( Other Identifier: Tibotec-Virco Virology BVBA )
First Posted: June 23, 2008    Key Record Dates
Results First Posted: August 11, 2011
Last Update Posted: January 22, 2014
Last Verified: December 2013
Keywords provided by Tibotec BVBA:
Hepatitis C, Chronic
Telaprevir
Peg-IFN-alfa-2a
Ribavirin
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Interferon alpha-2
Peginterferon alfa-2a
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents