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A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response

This study has been completed.
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00758043
First received: September 19, 2008
Last updated: September 30, 2013
Last verified: June 2011
  Purpose

This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who respond quickly to a telaprevir-based treatment.


Condition Intervention Phase
Hepatitis C
Drug: telaprevir
Drug: ribavirin
Biological: peginterferon alfa-2a
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Study of Stopping Treatment at 24 Weeks or Continuing Treatment to 48 Weeks in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response While Receiving Telaprevir, Peginterferon Alfa2a (Pegasys®) and Ribavirin (Copegus®)

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24) [ Time Frame: 24 weeks after the last planned dose of study treatment ] [ Designated as safety issue: No ]
    SVR24planned was used to measure the primary outcome. SVR24 planned is defined as undetectable HCV RNA levels at the end of treatment (EOT) visit and at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA levels in between those visits. All plasma HCV RNA levels were assessed using the Roche TaqMan HCV RNA assay (Version 2.0, lower limit of quantification [LLOQ] of 25 IU/mL).


Secondary Outcome Measures:
  • Proportion of Subjects Who Have Undetectable HCV RNA at Week 72 [ Time Frame: 72 weeks after the last planned dose of study treatment ] [ Designated as safety issue: No ]
    SVR at Week 72 is defined as achieved SVR24planned and undetectable HCV RNA at Week 72 without any confirmed detectable HCV RNA levels in between those visits.

  • Proportion of Subjects Achieving eRVR (Extended RVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12 [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Extended rapid viral response is defined undetectable HCV RNA levels at Week 4 and Week 12 (on treatment).

  • Proportion of Randomized Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Dose of Study Treatment [ Time Frame: 12 weeks after last dose of study treatment ] [ Designated as safety issue: No ]
    SVR12 is defined as undetectable HCV RNA levels 12 weeks after the last planned dose of study treatment.

  • Proportion of Randomized Subjects Who Relapse, Defined as Those Who Complete Treatment, Have Undetectable HCV RNA at End of Treatment (EOT; Week 24 or Week 48 Respectively), and Become HCV RNA Detectable During Antiviral Follow-up [ Time Frame: Week 24 or Week 28 ] [ Designated as safety issue: No ]
  • Proportion of Enrolled Subjects Who Relapse, Defined as Those Who Have Undetectable HCV RNA at the EOT, and Become HCV RNA Detectable During Antiviral Follow-up [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
  • Proportion of Subjects Who Have Undetectable HCV RNA at the EOT (Week 24 or Week 48 Respectively). [ Time Frame: Week 24 or Week 48 ] [ Designated as safety issue: No ]
  • Adverse Events, Physical Examination Findings, and Clinical Laboratory, Vital Sign, and Electrocardiogram (ECG) Assessments [ Time Frame: Week 72 ] [ Designated as safety issue: Yes ]

Enrollment: 540
Study Start Date: October 2008
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: T12PR24 (eRVR+)
Randomized Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 12 weeks; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
Drug: telaprevir
750 mg every 8 hours (q8h) for 12 weeks
Other Name: VX-950
Drug: ribavirin
1000 - 1200 mg/day based on body weight for either 24 or 48 weeks
Other Name: Copegus
Biological: peginterferon alfa-2a
180 mcg/week for either 24 or 48 weeks
Other Name: Pegasys
Experimental: T12PR48 (eRVR+)
Randomized Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group
Drug: telaprevir
750 mg every 8 hours (q8h) for 12 weeks
Other Name: VX-950
Drug: ribavirin
1000 - 1200 mg/day based on body weight for either 24 or 48 weeks
Other Name: Copegus
Biological: peginterferon alfa-2a
180 mcg/week for either 24 or 48 weeks
Other Name: Pegasys
Experimental: T12PR48 (eRVR-)
Assigned Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks; subjects did not achieve an extended rapid viral response and were assigned to this group
Drug: telaprevir
750 mg every 8 hours (q8h) for 12 weeks
Other Name: VX-950
Drug: ribavirin
1000 - 1200 mg/day based on body weight for either 24 or 48 weeks
Other Name: Copegus
Biological: peginterferon alfa-2a
180 mcg/week for either 24 or 48 weeks
Other Name: Pegasys
Experimental: Other
Other Group: Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen.
Drug: telaprevir
750 mg every 8 hours (q8h) for 12 weeks
Other Name: VX-950
Drug: ribavirin
1000 - 1200 mg/day based on body weight for either 24 or 48 weeks
Other Name: Copegus
Biological: peginterferon alfa-2a
180 mcg/week for either 24 or 48 weeks
Other Name: Pegasys

  Eligibility

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

Inclusion Criteria:

  • Has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
  • Male and female subjects, 18 to 70 years of age, inclusive
  • Genotype 1, chronic hepatitis C with detectable HCV RNA.
  • Screening laboratory values, tests, and physical exam within acceptable ranges
  • Able and willing to follow contraception requirements
  • Able to read and understand, and willing to sign the informed consent form and abide by the study restrictions.

Exclusion Criteria:

  • Subject has any contraindications to Pegasys® or Copegus® therapy
  • Evidence of hepatic decompensation in cirrhotic subjects
  • History of organ transplant
  • History of, or any current medical condition which could impact the safety of the subject in participation in the study
  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: NCT00758043

  Show 82 Study Locations
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Tibotec Pharmaceutical Limited
Investigators
Principal Investigator: Michael Adler, MD, PhD Erasmus Hospital Bruxelles
Principal Investigator: Hendrik Reesink, MD, PhD Academic Medical Center of the University of Amsterdam
Principal Investigator: Kenneth Sherman, MD, PhD University of Cincinnati
  More Information

No publications provided by Vertex Pharmaceuticals Incorporated

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00758043     History of Changes
Other Study ID Numbers: VX08-950-111, EudraCT 2008-003836-39
Study First Received: September 19, 2008
Results First Received: June 22, 2011
Last Updated: September 30, 2013
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Vertex Pharmaceuticals Incorporated:
Genotype 1

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

ClinicalTrials.gov processed this record on November 20, 2014