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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00720434

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 II

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:

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

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
A: Experimental 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.
B: Experimental 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
C: Experimental 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
D: Placebo Comparator 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

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
ClinicalTrials.gov Identifier:	NCT00720434 History of Changes
Other Study ID Numbers:	A8121007
Study First Received:	July 18, 2008
Last Updated:	April 6, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases

Flaviviridae Infections
RNA Virus Infections
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 01, 2010