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Filibuvir In Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Subjects (FITNESS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00987337
First received: September 29, 2009
Last updated: December 10, 2013
Last verified: December 2013
Results First Received: December 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Hepatitis
Hepatitis C
Interventions: Drug: Filibuvir
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Filibuvir 300 mg Plus pegIFN/RBV Filibuvir 300 milligram (mg) tablet orally twice daily as blinded therapy along with pegylated interferon alpha-2a (pegIFN alpha-2a) 180 microgram (mcg) subcutaneously once weekly and ribavirin (RBV) 1000 milligram per day (mg/day) to participants weighing less than or equal to(<=) 75 kilogram (kg) or RBV 1200 mg/day to participants weighing greater than (>) 75 kg, orally in 2 divided doses up to Week 24. Participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) (HCV RNA <15 international units/milliliter [IU/mL]) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (greater than or equal to [>=] 15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75kg or RBV 1200 mg/day if participant weighed >75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
Filibuvir 600 mg Plus pegIFN/RBV Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
Placebo Plus pegIFN/RBV Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.

Participant Flow:   Overall Study
    Filibuvir 300 mg Plus pegIFN/RBV     Filibuvir 600 mg Plus pegIFN/RBV     Placebo Plus pegIFN/RBV  
STARTED     96     96     96  
COMPLETED     39     41     45  
NOT COMPLETED     57     55     51  
Adverse Event                 10                 9                 8  
Insufficient Virologic Response                 10                 7                 12  
Virologic Breakthrough                 2                 2                 8  
Lost to Follow-up                 10                 6                 2  
Withdrawal by Subject                 6                 9                 9  
Unspecified                 0                 2                 5  
Protocol Violation                 1                 0                 2  
Participant Relapsed                 18                 20                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-Treat (ITT) population included all randomized participants who took at least 1 dose of study drug.

Reporting Groups
  Description
Filibuvir 300 mg Plus pegIFN/RBV Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
Filibuvir 600 mg Plus pegIFN/RBV Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
Placebo Plus pegIFN/RBV Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
Total Total of all reporting groups

Baseline Measures
    Filibuvir 300 mg Plus pegIFN/RBV     Filibuvir 600 mg Plus pegIFN/RBV     Placebo Plus pegIFN/RBV     Total  
Number of Participants  
[units: participants]
  96     96     96     288  
Age, Customized  
[units: participants]
       
18 to 44 years     36     25     31     92  
45 to 64 years     56     68     61     185  
>=65 years     4     3     4     11  
Gender  
[units: participants]
       
Female     44     47     44     135  
Male     52     49     52     153  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Sustained Viral Response (SVR) at Week 72   [ Time Frame: Week 72 ]

2.  Secondary:   Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4, 12, 24 and 48   [ Time Frame: Week 4, 12, 24, 48 ]

3.  Secondary:   Percentage of Participants With Sustained Viral Response at 12 Weeks Following Completion of Therapy (SVR12)   [ Time Frame: 12 weeks after completion of therapy (Week 36 or 60) ]

4.  Secondary:   Percentage of Participants With Sustained Viral Response at 24 Weeks Following Completion of Therapy (SVR24)   [ Time Frame: 24 weeks after completion of therapy (Week 48 or 72) ]

5.  Secondary:   Percentage of Participants With Breakthrough Viremia   [ Time Frame: Baseline up to Week 48 ]

6.  Secondary:   Percentage of Participants With Relapsed Response   [ Time Frame: Week 24 or Week 48 up to Week 72 ]

7.  Secondary:   Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4, 12 and 24   [ Time Frame: Baseline, Week 4, 12, 24 ]

8.  Secondary:   Number of Adverse Events (AEs) by Severity (All Causality)   [ Time Frame: Baseline up to Week 72 ]

9.  Secondary:   Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Relationship to Study Drug (Any Therapy)   [ Time Frame: Baseline up to Week 72 ]

10.  Secondary:   Number of Participants Who Discontinued Study Due to Adverse Events (AEs)   [ Time Frame: Baseline up to Week 72 ]

11.  Secondary:   Number of Participants With Dose Reduction or Temporary Discontinuation Due to Adverse Events (AEs)   [ Time Frame: Baseline up to Week 72 ]

12.  Secondary:   Number of Participants With Laboratory Test Abnormalities by Severity   [ Time Frame: Baseline up to Week 72 ]

13.  Secondary:   Plasma Concentration of Filibuvir, Pegylated Interferon and Ribavirin   [ Time Frame: Week 0 (pre-dose), Week 2, 4, 8, 12, 16, 20, 24, 48 (only for those participants who received treatment till Week 48) post-dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00987337     History of Changes
Other Study ID Numbers: A8121014
Study First Received: September 29, 2009
Results First Received: December 10, 2013
Last Updated: December 10, 2013
Health Authority: United States: Food and Drug Administration