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A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
La Jolla, California, 92037 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

- Treatment naive (no prior treatment with IFN-a +/- RBV regimens.

- Subjects who have discontinued IFN-a containing regimens after to tolerability issues are considered treatment naive.

- HCV RNA > 100,000 IU/mL at screening.

- Genotype 1.

- A diagnosis of chronic HCV infection for at least 6 months.

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

- Evidence of acute or chronic infection with HIV or HBV.

- Exposure within the previous three months to an investigational anti-HCV agent.

- Evidence of severe or decompensated liver disease.

- Subjects with liver disease unrelated to HCV infection.

NCT00720434
Pfizer
Completed
A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection

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A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection
A Phase 2, Randomized, Placebo Controlled, Dose Ranging Study To Evaluate Peginterferon Alfa 2a (Pegasys®) And Ribavirin (Copegus®) With And Without PF-00868554 In Subjects Chronically Infected With Hepatitis C Virus
The purpose of this study is to further assess the potency of PF-00868554, an HCV polymerase inhibitor, in subjects chronically infected with HCV by evaluating the antiviral activity of PF-00868554 in combination with current standard of care therapy, pegylated interferon-alpha2a (PEGASYS) and ribavirin (COPEGUS).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Hepatitis C
  • Drug: PF-00868554
    500 mg BID administered as 5x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks.
  • Drug: PF-00868554
    300 mg BID administered as 3x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks
  • Drug: PF-00868554
    200 mg BID administered as 2x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks
  • Drug: Placebo
    Placebo administered for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks
  • Experimental: A
    500 mg BID
    Intervention: Drug: PF-00868554
  • Experimental: B
    300 mg BID
    Intervention: Drug: PF-00868554
  • Experimental: C
    200 mg BID
    Intervention: Drug: PF-00868554
  • Placebo Comparator: D
    Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
March 2010
March 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Treatment naive (no prior treatment with IFN-a +/- RBV regimens.
  • Subjects who have discontinued IFN-a containing regimens after <2 weeks of therapy due to tolerability issues are considered treatment naive.
  • HCV RNA > 100,000 IU/mL at screening.
  • Genotype 1.
  • A diagnosis of chronic HCV infection for at least 6 months.

Exclusion Criteria:

  • Evidence of acute or chronic infection with HIV or HBV.
  • Exposure within the previous three months to an investigational anti-HCV agent.
  • Evidence of severe or decompensated liver disease.
  • Subjects with liver disease unrelated to HCV infection.
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
 
 
NCT00720434
A8121007
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2013

ICMJE     Data element required by the

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

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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.

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