Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Pfizer |
---|---|
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00720434 |
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: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 40 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 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
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
United States, California | |
Pfizer Investigational Site | Recruiting |
La Jolla, California, United States, 92037 | |
Pfizer Investigational Site | Active, not recruiting |
San Francisco, California, United States, 94115 | |
United States, Florida | |
Pfizer Investigational Site | Active, not recruiting |
Orlando, Florida, United States, 32803 | |
United States, Massachusetts | |
Pfizer Investigational Site | Active, not recruiting |
Springfield, Massachusetts, United States, 01107 | |
United States, New York | |
Pfizer Investigational Site | Active, not recruiting |
New York, New York, United States, 10021 | |
Pfizer Investigational Site | Active, not recruiting |
New York, New York, United States, 10065 | |
United States, Oklahoma | |
Pfizer Investigational Site | Completed |
Tulsa, Oklahoma, United States, 74135 | |
United States, Tennessee | |
Pfizer Investigational Site | Recruiting |
Nashville, Tennessee, United States, 37205 | |
United States, Texas | |
Pfizer Investigational Site | Recruiting |
San Antonio, Texas, United States, 78215 | |
Puerto Rico | |
Pfizer Investigational Site | Active, not recruiting |
Santurce, Puerto Rico, 00909 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A8121007 |
Study First Received: | July 18, 2008 |
Last Updated: | August 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00720434 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Ribavirin Peginterferon alfa-2a Hepatitis, Viral, Human Hepatitis C Hepatitis C, Chronic |
Virus Diseases Hepatitis RNA Virus Infections Liver Diseases |
Digestive System Diseases Flaviviridae Infections Hepatitis, Viral, Human Hepatitis C |