A Study Evaluating the Safety and Clinical Activity of HCV-796 in Treatment-Naive and Non-Responder Subjects
A Phase 2, Randomized, Open-Label Study Of The Safety, Antiviral Activity, And Pharmacokinetics Of HCV-796 Administered In Combination With Peginterferon Alfa 2B (Peg-Intron) Plus Ribavirin (Rebetol) Versus Peg-Intron Plus Rebetol In Subjects With Hepatitis C Virus Genotype 1 Infection
2 other identifiers
interventional
246
2 countries
35
Brief Summary
This is a phase 2, randomized, open-label study comparing the safety, antiviral activity, and pharmacokinetics of HCV-796 administered in combination with peginterferon alfa 2B (Peg-Intron) plus concomitant Rebetol vs. Peg-Intron plus Rebetol in Hepatitis C Virus (HCV) genotype 1-infected subjects who are either naive to treatment or who have previously failed treatment (non-responders).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2006
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2006
CompletedFirst Posted
Study publicly available on registry
August 23, 2006
CompletedStudy Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedFebruary 11, 2013
February 1, 2013
1.8 years
August 21, 2006
February 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hepatitis C Virus (HCV) RNA concentrations in the blood.
72 weeks
Study Arms (3)
1
ACTIVE COMPARATOR2
ACTIVE COMPARATOR3
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Infection with HCV genotype 1.
- HCV- infected subjects naive to treatment.
- HCV-infected non-responder subjects.
You may not qualify if:
- Women who are pregnant or breastfeeding.
- ALT \>/ or = 5X the upper limit of normal.
- AST \>/ or = 5X the upper limit of normal.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizerlead
- ViroPharmacollaborator
Study Sites (35)
Pfizer Investigational Site
Anaheim, California, 92801, United States
Pfizer Investigational Site
La Jolla, California, 92037, United States
Pfizer Investigational Site
La Jolla, California, 92067, United States
Pfizer Investigational Site
Los Angeles, California, 90033, United States
Pfizer Investigational Site
Pasadena, California, 91105, United States
Pfizer Investigational Site
San Diego, California, 92123, United States
Pfizer Investigational Site
San Diego, California, 92161, United States
Pfizer Investigational Site
San Francisco, California, 94115, United States
Pfizer Investigational Site
San Francisco, California, 94121, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, 20010, United States
Pfizer Investigational Site
Gainesville, Florida, 32610, United States
Pfizer Investigational Site
Miami, Florida, 33136, United States
Pfizer Investigational Site
Atlanta, Georgia, 30309, United States
Pfizer Investigational Site
Louisville, Kentucky, 40202, United States
Pfizer Investigational Site
Boston, Massachusetts, 02215, United States
Pfizer Investigational Site
Worcester, Massachusetts, 01655, United States
Pfizer Investigational Site
Detroit, Michigan, 48202, United States
Pfizer Investigational Site
Plymouth, Minnesota, 55446, United States
Pfizer Investigational Site
Saint Paul, Minnesota, 55117, United States
Pfizer Investigational Site
St Louis, Missouri, 63104, United States
Pfizer Investigational Site
Albuquerque, New Mexico, 87131, United States
Pfizer Investigational Site
New York, New York, 10021, United States
Pfizer Investigational Site
New York, New York, 10032, United States
Pfizer Investigational Site
The Bronx, New York, 10461, United States
Pfizer Investigational Site
The Bronx, New York, 10468, United States
Pfizer Investigational Site
Chapel Hill, North Carolina, 27599-7209, United States
Pfizer Investigational Site
Durham, North Carolina, 27710, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45219, United States
Pfizer Investigational Site
Cleveland, Ohio, 44195, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19141, United States
Pfizer Investigational Site
Houston, Texas, 77030, United States
Pfizer Investigational Site
Annandale, Virginia, 22003, United States
Pfizer Investigational Site
Fairfax, Virginia, 22031, United States
Pfizer Investigational Site
Richmond, Virginia, 23249, United States
Pfizer Investigational Site
Santurce, 00909, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2006
First Posted
August 23, 2006
Study Start
October 1, 2006
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
February 11, 2013
Record last verified: 2013-02