A Study Evaluating the Safety and Clinical Activity of HCV-796 in Treatment-Naive and Non-Responder Subjects

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NCT00367887

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Study Location
Pfizer Investigational Site
Anaheim, California, 92801, United States
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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Contact

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hepatitis C
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Infection with HCV genotype 1.

- HCV- infected subjects naive to treatment.

- HCV-infected non-responder subjects.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Women who are pregnant or breastfeeding.


- ALT >/ or = 5X the upper limit of normal.


- AST >/ or = 5X the upper limit of normal.

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Hepatitis CA Study Evaluating the Safety and Clinical Activity of HCV-796 in Treatment-Naive and Non-Responder Subjects
NCT00367887
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  4. Los Angeles, California
  5. Pasadena, California
  6. San Diego, California
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  13. Atlanta, Georgia
  14. Louisville, Kentucky
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  16. Worcester, Massachusetts
  17. Detroit, Michigan
  18. Plymouth, Minnesota
  19. St. Paul, Minnesota
  20. St. Louis, Missouri
  21. Albuquerque, New Mexico
  22. Bronx, New York
  23. Bronx, New York
  24. New York, New York
  25. New York, New York
  26. Chapel Hill, North Carolina
  27. Durham, North Carolina
  28. Cincinnati, Ohio
  29. Cleveland, Ohio
  30. Philadelphia, Pennsylvania
  31. Houston, Texas
  32. Annandale, Virginia
  33. Fairfax, Virginia
  34. Richmond, Virginia
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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Evaluating the Safety and Clinical Activity of HCV-796 in Treatment-Naive and Non-Responder Subjects
Official Title  ICMJE A Phase 2, Randomized, Open-Label Study Of The Safety, Antiviral Activity, And Pharmacokinetics Of HCV-796 Administered In Combination With Peginterferon Alfa 2B (Peg-Intron) Plus Ribavirin (Rebetol) Versus Peg-Intron Plus Rebetol In Subjects With Hepatitis C Virus Genotype 1 Infection
Brief Summary

This is a phase 2, randomized, open-label study comparing the safety, antiviral activity, and pharmacokinetics of HCV-796 administered in combination with peginterferon alfa 2B (Peg-Intron) plus concomitant Rebetol vs. Peg-Intron plus Rebetol in Hepatitis C Virus (HCV) genotype

1-infected subjects who are either naive to treatment or who have previously failed treatment (non-responders).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Drug: Peg-Intron
    SC injection, weight based dosing, weekly, 48 weeks
  • Drug: REBETOL
    Capsules, weight based dosing, Q12 hrs daily, 48weeks
  • Drug: HCV 796
    Capsules, 500 mg, Q 12 hrs. daily, 48 weeks
Study Arms  ICMJE
  • Active Comparator: 1
    Interventions:
    • Drug: Peg-Intron
    • Drug: REBETOL
  • Active Comparator: 2
    Interventions:
    • Drug: HCV 796
    • Drug: Peg-Intron
    • Drug: REBETOL
  • Active Comparator: 3
    Interventions:
    • Drug: HCV 796
    • Drug: Peg-Intron
    • Drug: REBETOL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 14, 2011)		246
Original Enrollment  ICMJE
 (submitted: August 21, 2006)		267
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Infection with HCV genotype 1.
  • HCV- infected subjects naive to treatment.
  • HCV-infected non-responder subjects.

Exclusion Criteria:

  • Women who are pregnant or breastfeeding.
  • ALT >/ or = 5X the upper limit of normal.
  • AST >/ or = 5X the upper limit of normal.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00367887
Other Study ID Numbers  ICMJE 3173A1-200
B3381001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE ViroPharma
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date February 2013

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