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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Anaheim, California, 92801 United States
Contact
1-800-718-1021
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.

NCT00367887
Pfizer
Completed
A Study Evaluating the Safety and Clinical Activity of HCV-796 in Treatment-Naive and Non-Responder Subjects

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

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hepatitis C
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
246
July 2008
July 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
United Kingdom
 
NCT00367887
3173A1-200
B3381001
No
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
ViroPharma
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
February 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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