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
  Purpose

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).


Condition Intervention Phase
Hepatitis C
Drug: PF-00868554
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 35
Study Start Date: August 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
500 mg BID
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.
Experimental: B
300 mg BID
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
Experimental: C
200 mg BID
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
Placebo Comparator: D
Placebo
Drug: Placebo
Placebo administered for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720434

Locations
United States, California
Pfizer Investigational Site
La Jolla, California, United States, 92037
Pfizer Investigational Site
San Francisco, California, United States, 94115
United States, Florida
Pfizer Investigational Site
Orlando, Florida, United States, 32803
United States, Massachusetts
Pfizer Investigational Site
Springfield, Massachusetts, United States, 01107
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10021
Pfizer Investigational Site
New York, New York, United States, 10065
United States, Oklahoma
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74135
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37205
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78215
Puerto Rico
Pfizer Investigational Site
Santurce, Puerto Rico, 00909
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00720434     History of Changes
Other Study ID Numbers: A8121007
Study First Received: July 18, 2008
Results First Received: June 18, 2013
Last Updated: June 18, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014