A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection
NCT ID: NCT00720434
Last Updated: 2013-08-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2008-08-31
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
500 mg BID
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
300 mg BID
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
200 mg BID
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
Placebo
Placebo administered for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks
Interventions
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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.
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
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
Placebo administered for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
La Jolla, California, United States
Pfizer Investigational Site
San Francisco, California, United States
Pfizer Investigational Site
Orlando, Florida, United States
Pfizer Investigational Site
Springfield, Massachusetts, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Tulsa, Oklahoma, United States
Pfizer Investigational Site
Nashville, Tennessee, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Santurce, , Puerto Rico
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A8121007
Identifier Type: -
Identifier Source: org_study_id