Filibuvir In Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Subjects
NCT00987337
ABOUT THIS STUDY
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- Male or female subjects at least 18 years of age.
- 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.
- Co-infection with either HIV or HBV.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Filibuvir In Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Subjects | |||
Official Title ICMJE | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Efficacy Of Filibuvir Plus Pegylated Interferon Alfa-2a And Ribavirin In Treatment-Naive, HCV Genotype 1 Infected Subjects | |||
Brief Summary | The primary objective for this study is to determine if the addition of filibuvir to a standard regimen of peginterferon/ribavirin (pegIFN/RBV) significantly increases the proportion of subjects who achieve a sustained viral response (SVR) compared to peginterferon/ribavirin (pegIFN/RBV) therapy alone. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
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Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 288 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | January 2012 | |||
Actual Primary Completion Date | January 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Canada, France, Germany, Hungary, Korea, Republic of, Puerto Rico, Spain, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00987337 | |||
Other Study ID Numbers ICMJE | A8121014 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | December 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |