A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00720434
First received: July 18, 2008
Last updated: June 18, 2013
Last verified: June 2013
Results First Received: June 18, 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
Condition: Hepatitis C
Interventions: Drug: PF-00868554
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
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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
PF-00868554 200 mg + pegIFN Alfa-2a/RBV PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
PF-00868554 300 mg + pegIFN Alfa-2a/RBV PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
PF-00868554 500 mg + pegIFN Alfa-2a/RBV PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
Placebo + pegIFN Alfa-2a/RBV Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.

Participant Flow for 2 periods

Period 1:   Double-Blind Period (Week 1-4)
    PF-00868554 200 mg + pegIFN Alfa-2a/RBV     PF-00868554 300 mg + pegIFN Alfa-2a/RBV     PF-00868554 500 mg + pegIFN Alfa-2a/RBV     Placebo + pegIFN Alfa-2a/RBV  
STARTED     10     9     8     8  
COMPLETED     10     8     8     8  
NOT COMPLETED     0     1     0     0  
Withdrawal by Subject                 0                 1                 0                 0  

Period 2:   Open-Label Period (Week 5-72)
    PF-00868554 200 mg + pegIFN Alfa-2a/RBV     PF-00868554 300 mg + pegIFN Alfa-2a/RBV     PF-00868554 500 mg + pegIFN Alfa-2a/RBV     Placebo + pegIFN Alfa-2a/RBV  
STARTED     10     8     8     8  
COMPLETED     4     5     4     4  
NOT COMPLETED     6     3     4     4  
Adverse Event                 0                 0                 0                 2  
Lost to Follow-up                 1                 0                 0                 0  
Withdrawal by Subject                 1                 0                 1                 0  
Unspecified                 4                 3                 3                 2  



  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.
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Reporting Groups
  Description
PF-00868554 200 mg + pegIFN Alfa-2a/RBV PF-00868554 200 milligram (mg) (2 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegylated interferon alfa-2a (pegIFN alfa-2a) 180 microgram (mcg) subcutaneously once weekly starting from Day 1 and ribavirin (RBV) 1000 mg/day tablet orally in 2 divided doses for participants weighing less than or equal to (<=) 75 kilogram (kg); 1200 mg/day orally in 2 divided doses for participants weighing greater than (>) 75 kg.
PF-00868554 300 mg + pegIFN Alfa-2a/RBV PF-00868554 300 mg (3 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
PF-00868554 500 mg + pegIFN Alfa-2a/RBV PF-00868554 500 mg (5 PF-00868554 100 mg tablets) orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
Placebo + pegIFN Alfa-2a/RBV Placebo matched to PF-00868554 tablets orally twice daily in combination with standard of care during Week 1 to 4 in blinded treatment period, followed by standard of care as per investigator's discretion up to Week 48, then off-treatment up to Week 72 in open-label period. Standard of care included pegIFN alfa-2a 180 mcg subcutaneously once weekly starting from Day 1 and RBV 1000 mg/day tablet orally in 2 divided doses for participants weighing <=75 kg; 1200 mg/day orally in 2 divided doses for participants weighing >75 kg.
Total Total of all reporting groups

Baseline Measures
    PF-00868554 200 mg + pegIFN Alfa-2a/RBV     PF-00868554 300 mg + pegIFN Alfa-2a/RBV     PF-00868554 500 mg + pegIFN Alfa-2a/RBV     Placebo + pegIFN Alfa-2a/RBV     Total  
Number of Participants  
[units: participants]
  10     9     8     8     35  
Age, Customized  
[units: participants]
         
18 to 44 years     5     3     3     1     12  
45 to 64 years     5     6     5     7     23  
Gender  
[units: participants]
         
Female     3     7     2     5     17  
Male     7     2     6     3     18  



  Outcome Measures
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1.  Primary:   Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set   [ Time Frame: Baseline, Week 4 ]

2.  Primary:   Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set   [ Time Frame: Baseline, Week 4 ]

3.  Secondary:   Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)   [ Time Frame: Week 4, 12, 48, 60, 72 ]

4.  Secondary:   Alanine Aminotransferase (ALT) Levels   [ Time Frame: Week 4, 12, 48, 72 ]

5.  Secondary:   Population Pharmacokinetics (PK) of PF-00868554   [ Time Frame: 1, 2 and 6 hours post-dose on Day 1; 0 hour (pre-dose) on Day 7, 14, 21; 0 hour (pre-dose), 2, 6 hours post-dose on Day 28 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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: NCT00720434     History of Changes
Other Study ID Numbers: A8121007
Study First Received: July 18, 2008
Results First Received: June 18, 2013
Last Updated: June 18, 2013
Health Authority: United States: Food and Drug Administration