A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 HCV

This study has been completed.
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00627926
First received: February 22, 2008
Last updated: June 22, 2011
Last verified: June 2011

February 22, 2008
June 22, 2011
March 2008
May 2010   (final data collection date for primary outcome measure)
Proportion of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Planned Dose of Study Treatment [ Time Frame: 24 weeks after last dose of study treatment ] [ Designated as safety issue: No ]
To demonstrate the efficacy of telaprevir in combination with Pegasys® and Copegus® in treatment naive subjects with genotype 1 chronic hepatitis C. [ Time Frame: Prospective ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00627926 on ClinicalTrials.gov Archive Site
  • Proportion of Subjects Who Have Undetectable HCV RNA at Week 72 [ Time Frame: 24 weeks after last planned dose for subjects with a planned treatment duration of 48 weeks, and 48 weeks after last planned dose for subjects with a planned treatment duration of 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of Subjects Achieving a Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment [ Time Frame: 4 weeks after starting study treatment ] [ Designated as safety issue: No ]
  • Proportion of Subjects Achieving Extended Rapid Viral Response (eRVR), 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 ]
  • Proportion of Subjects Who Have Undetectable HCV RNA at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Proportion of Subjects Who Have Undetectable HCV RNA at the End of Treatment (EOT) [ Time Frame: Week 24 or Week 48, depending on planned treatment duration ] [ Designated as safety issue: No ]
  • Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment (SVR12Planned) [ Time Frame: 12 weeks after last planned dose of study treatment ] [ Designated as safety issue: No ]
  • Proportion of Subjects Who Have Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment (SVR24Actual) [ Time Frame: 24 weeks after last actual dose of study treatment ] [ Designated as safety issue: No ]
  • Proportion of Subjects Who Relapse, Defined as Those Who Complete Treatment as Assigned, Have Undetectable HCV RNA at EOT, and Become HCV RNA Detectable During Antiviral Follow-up [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
  • Proportion of 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 ]
  • Biochemical Response Including Transaminase Levels [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
  • Noninvasive Markers of Fibrosis [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
  • Total Fatigue Score From the Fatigue Severity Scale (FSS) [ Time Frame: Week 72 ] [ 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: No ]
To evaluate the safety of telaprevir in combination with Pegasys® and Copegus® in treatment naive subjects with genotype 1 chronic hepatitis C. [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 HCV
A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C

A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with peginterferon alfa-2a and ribavirin.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hepatitis C
  • Biological: peginterferon alfa-2a
    subcutaneous injection, 180 micrograms once per week
    Other Name: Pegasys, Peg-IFN
  • Drug: telaprevir
    375 mg tablets administered orally every 8 hours at a dose of 750 mg
    Other Name: TVR, VX-950
  • Drug: ribavirin
    200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing ≥75 kg
    Other Name: Copegus, RBV
  • Other: placebo
    telaprevir-matching placebo
  • Placebo Comparator: Placebo12/PR48
    Placebo matching telaprevir in combination with peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin
    Interventions:
    • Biological: peginterferon alfa-2a
    • Drug: ribavirin
    • Other: placebo
  • Experimental: T8/Placebo4/PR24or48
    Telaprevir plus peginterferon alfa-2a and ribavirin for 8 weeks, followed by 4 weeks of telaprevir matching placebo plus peginterferon alfa-2a and ribavirin, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.
    Interventions:
    • Biological: peginterferon alfa-2a
    • Drug: telaprevir
    • Drug: ribavirin
    • Other: placebo
  • Experimental: T12/PR24or48
    Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.
    Interventions:
    • Biological: peginterferon alfa-2a
    • Drug: telaprevir
    • Drug: ribavirin
Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, Marcellin P, Muir AJ, Ferenci P, Flisiak R, George J, Rizzetto M, Shouval D, Sola R, Terg RA, Yoshida EM, Adda N, Bengtsson L, Sankoh AJ, Kieffer TL, George S, Kauffman RS, Zeuzem S; ADVANCE Study Team. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011 Jun 23;364(25):2405-16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1095
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Canada,   France,   Germany,   Israel,   Italy,   Poland,   Puerto Rico,   Spain,   United Kingdom
 
NCT00627926
VX07-950-108
Yes
Shelley George, M.D., Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Tibotec Pharmaceutical Limited
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP