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

NCT00720434

Last updated date
Study Location
Pfizer Investigational Site
La Jolla, California, 92037, United States
Contact
1-800-718-1021

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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

- 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
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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection
Official Title  ICMJE 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
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
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 6, 2010)
35
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2008)
40
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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  
 
Administrative Information
NCT Number  ICMJE NCT00720434
Other Study ID Numbers  ICMJE A8121007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2013

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