A Study Evaluating the Safety and Clinical Activity of HCV-796 in Treatment-Naive and Non-Responder Subjects
NCT ID: NCT00367887
Last Updated: 2013-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
246 participants
INTERVENTIONAL
2006-10-31
2008-07-31
Brief Summary
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1-infected subjects who are either naive to treatment or who have previously failed treatment (non-responders).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Peg-Intron
SC injection, weight based dosing, weekly, 48 weeks
REBETOL
Capsules, weight based dosing, Q12 hrs daily, 48weeks
2
HCV 796
Capsules, 500 mg, Q 12 hrs. daily, 48 weeks
Peg-Intron
SC injection, weight based dosing, weekly, 48 weeks
REBETOL
Capsules, weight based dosing, Q12 hrs daily, 48weeks
3
HCV 796
Capsules, 500 mg, Q 12 hrs. daily, 48 weeks
Peg-Intron
SC injection, weight based dosing, weekly, 48 weeks
REBETOL
Capsules, weight based dosing, Q12 hrs daily, 48weeks
Interventions
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Peg-Intron
SC injection, weight based dosing, weekly, 48 weeks
REBETOL
Capsules, weight based dosing, Q12 hrs daily, 48weeks
HCV 796
Capsules, 500 mg, Q 12 hrs. daily, 48 weeks
Peg-Intron
SC injection, weight based dosing, weekly, 48 weeks
REBETOL
Capsules, weight based dosing, Q12 hrs daily, 48weeks
HCV 796
Capsules, 500 mg, Q 12 hrs. daily, 48 weeks
Peg-Intron
SC injection, weight based dosing, weekly, 48 weeks
REBETOL
Capsules, weight based dosing, Q12 hrs daily, 48weeks
Eligibility Criteria
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Inclusion Criteria
* HCV- infected subjects naive to treatment.
* HCV-infected non-responder subjects.
Exclusion Criteria
* ALT \>/ or = 5X the upper limit of normal.
* AST \>/ or = 5X the upper limit of normal.
18 Years
65 Years
ALL
No
Sponsors
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ViroPharma
INDUSTRY
Wyeth is now a wholly owned subsidiary of 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
Anaheim, California, United States
Pfizer Investigational Site
La Jolla, California, United States
Pfizer Investigational Site
La Jolla, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Pasadena, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
San Francisco, California, United States
Pfizer Investigational Site
San Francisco, California, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, United States
Pfizer Investigational Site
Gainesville, Florida, United States
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Louisville, Kentucky, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Worcester, Massachusetts, United States
Pfizer Investigational Site
Detroit, Michigan, United States
Pfizer Investigational Site
Plymouth, Minnesota, United States
Pfizer Investigational Site
Saint Paul, Minnesota, United States
Pfizer Investigational Site
St Louis, Missouri, United States
Pfizer Investigational Site
Albuquerque, New Mexico, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
The Bronx, New York, United States
Pfizer Investigational Site
The Bronx, New York, United States
Pfizer Investigational Site
Chapel Hill, North Carolina, United States
Pfizer Investigational Site
Durham, North Carolina, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
Annandale, Virginia, United States
Pfizer Investigational Site
Fairfax, Virginia, United States
Pfizer Investigational Site
Richmond, Virginia, 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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B3381001
Identifier Type: -
Identifier Source: secondary_id
3173A1-200
Identifier Type: -
Identifier Source: org_study_id
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