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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00720434
First received: July 18, 2008
Last updated: June 18, 2013
Last verified: June 2013

July 18, 2008
June 18, 2013
August 2008
March 2010   (final data collection date for primary outcome measure)
  • Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 international unit per milliliter [IU/mL]). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.
  • Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 IU/mL). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.
To assess the antiviral activity of PF-00868554 in combination with pegIFN-a and RBV over four weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00720434 on ClinicalTrials.gov Archive Site
  • Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) [ Time Frame: Week 4, 12, 48, 60, 72 ] [ Designated as safety issue: No ]
    Proportion of participants achieving undetectable plasma HCV RNA at Week 4 (rapid virologic response), at Week 12 (early virologic response), at Week 48 (end of treatment response), at Week 60 (sustained virologic response; 12 weeks after cessation of therapy), at Week 72 (sustained virologic response; 24 weeks after cessation of therapy) were summarized. Undetectable viral load was defined as HCV RNA <25 IU/mL.
  • Alanine Aminotransferase (ALT) Levels [ Time Frame: Week 4, 12, 48, 72 ] [ Designated as safety issue: No ]
  • Population Pharmacokinetics (PK) of PF-00868554 [ Time Frame: 1, 2 and 6 hours post-dose on Day 1; 0 hour (pre-dose) on Day 7, 14, 21; 0 hour (pre-dose), 2, 6 hours post-dose on Day 28 ] [ Designated as safety issue: No ]
    Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
  • To assess the safety and tolerability of PF-00868554 when administered in combination with pegIFN-a and RBV [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • To assess the pharmacokinetics of PF-00868554 when administered in combination with pegIFN-a and RBV [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • To assess the effect of four weeks of PF-00868554 therapy on long-term response to pegIFN-a/RBV therapy. [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00720434
A8121007
No
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