Filibuvir In Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Subjects
NCT ID: NCT00987337
Last Updated: 2014-01-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
288 participants
INTERVENTIONAL
2009-11-30
2012-01-31
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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Arm A
Filibuvir 300 mg BID + pegIFN/RBV x 24 weeks (subjects with undetectable HCV RNA at week 4)
\- or - Filibuvir 300 mg BID + pegIFN/RBV x 24 weeks followed by pegIFN/RBV x 24 weeks (subjects with detectable HCV RNA at week 4)
Filibuvir
300 mg BID
Arm B
Filibuvir 600 mg BID + pegIFN/RBV x 24 weeks (subjects with undetectable HCV RNA at week 4)
\- or - Filibuvir 600 mg BID + pegIFN/RBV x 24 weeks followed by pegIFN/RBV x 24 weeks (subjects with detectable HCV RNA at week 4)
Filibuvir
600 mg BID
Arm C
Placebo + pegIFN/RBV x 24 weeks followed by pegIFN/RBV x 24 weeks
Placebo
BID
Interventions
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Filibuvir
300 mg BID
Filibuvir
600 mg BID
Placebo
BID
Eligibility Criteria
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Inclusion Criteria
* HCV seropositive.
* HCV RNA \>10,000 IU/mL at screening.
* HCV Genotype 1. Subjects infected with a non-genotype 1 strain or mixed genotypes are not eligible.
* Treatment naïve (no prior treatment with IFN alfa +/ RBV regimens or investigational anti-HCV agents).
* Liver biopsy within two years (24 months) of Screening with non-cirrhotic fibrosis classification. For those subjects with liver biopsy outside of the time window or for those subjects with no history of liver biopsy, a biopsy must be performed prior to randomization.
* Ultrasound within 6 months of Screening for 1) those subjects with bridging fibrosis or 2) those subjects with AFP \>50 and \<100 ng/mL with no evidence of hepatocellular carcinoma. For those subjects with an ultrasound conducted outside the 6-month time window, an ultrasound must be performed prior to randomization.
Exclusion Criteria
* Evidence of severe or decompensated liver disease.
* Subjects with liver disease unrelated to HCV infection.
* Pre-existing medical condition that makes the subject unsuitable for treatment with pegIFN/RBV therapy per product labeling.
* Laboratory abnormality at Screening that makes the subject unsuitable for treatment with pegIFN/RBV therapy per product labeling.
* Abnormal ECG suggestive of clinically significant cardiac disease or QTc\>450msec.
* History of organ transplant.
* Contraindicated medications being taken by the subject at the time of randomization that must be continued during the study period, including potent CYP3A4 inhibitors, sensitive CYP3A4 substrates, CYP3A4 substrates with narrow therapeutic range and CYP3A4 inducers.
* Active alcohol or substance abuse sufficient, in the Investigator's judgment, to prevent adherence to study medication and/or follow up.
* Pregnant or nursing females.
* Males whose female partner is pregnant.
18 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
Anaheim, California, United States
Pfizer Investigational Site
Anaheim, California, United States
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Coronado, California, United States
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La Jolla, California, United States
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Mather, California, United States
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Sacramento, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Aurora, Colorado, United States
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Englewood, Colorado, United States
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DeLand, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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South Miami, Florida, United States
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Winter Park, Florida, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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New Orleans, Louisiana, United States
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Boston, Massachusetts, United States
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New York, New York, United States
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Durham, North Carolina, United States
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Durham, North Carolina, United States
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Philadelphia, Pennsylvania, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Richmond, Virginia, United States
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Brussels, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Ghent, , Belgium
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Haine-Saint-Paul, , Belgium
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Leuven, , Belgium
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Edmonton, Alberta, Canada
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Edmonton, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Halifax, Nova Scotia, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Clichy, , France
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Créteil, , France
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Marseille, , France
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Paris, , France
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Pessac, , France
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Rennes, , France
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Vandœuvre-lès-Nancy, , France
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Berlin, , Germany
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Bonn, , Germany
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Cologne, , Germany
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Düsseldorf, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Kiel, , Germany
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Békéscsaba, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Gyula, , Hungary
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Kaposvár, , Hungary
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Rio Piedras, , Puerto Rico
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, Barcelona, Spain
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Barcelona, Barcelona, Spain
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Córdoba, Cordoba, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
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Madrid, Madrid, Spain
Pfizer Investigational Site
Majadahonda, Madrid, Spain
Pfizer Investigational Site
Seville, Sevilla, Spain
Countries
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References
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Rodriguez-Torres M, Yoshida EM, Marcellin P, Srinivasan S, Purohit VS, Wang C, Hammond JL. A phase 2 study of filibuvir in combination with pegylated IFN alfa and ribavirin for chronic HCV. Ann Hepatol. 2014 Jul-Aug;13(4):364-75.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A8121014
Identifier Type: -
Identifier Source: org_study_id
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