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Filibuvir In Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Subjects (FITNESS)
This study is currently recruiting participants.
Verified by Pfizer, August 2010
First Received: September 29, 2009   Last Updated: August 5, 2010   History of Changes
Sponsor: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00987337
  Purpose

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.


Condition Intervention Phase
Hepatitis
Hepatitis C
Drug: Filibuvir
Drug: Placebo
Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Proportion of subjects with undetectable HCV RNA at the end of the study (SVR). [ Time Frame: Week 72 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with undetectable HCV RNA [ Time Frame: Weeks 4, 12, 24, and/or 48 ] [ Designated as safety issue: No ]
  • Proportion of subjects with undetectable HCV RNA 12 and 24 weeks following the completion of therapy (SVR12 and SVR24) [ Time Frame: Weeks 36, 48 or 60 ] [ Designated as safety issue: No ]
  • Proportion of subjects with breakthrough viremia [ Time Frame: Through Week 24 or 48 ] [ Designated as safety issue: No ]
  • Proportion of subjects with relapsed response [ Time Frame: Weeks 24-72 or 48-72 ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: Through Week 72 ] [ Designated as safety issue: Yes ]
  • Filibuvir, pegylated interferon and ribavirin concentrations [ Time Frame: Through Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 288
Study Start Date: November 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm A: Experimental

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)

Drug: Filibuvir
300 mg BID
Arm B: Experimental

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)

Drug: Filibuvir
600 mg BID
Arm C: Placebo Comparator
Placebo + pegIFN/RBV x 24 weeks followed by pegIFN/RBV x 24 weeks
Drug: Placebo
BID

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987337

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 78 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
ClinicalTrials.gov Identifier: NCT00987337     History of Changes
Other Study ID Numbers: A8121014
Study First Received: September 29, 2009
Last Updated: August 5, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Hepatitis C Polymerase Inhibitor PF-00868554 Filibuvir

Additional relevant MeSH terms:
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 01, 2010