A Phase 1 Study Of PF-00868554 In Hepatitis C Virus (HCV) Positive Patients

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NCT00445315

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Study Location
Pfizer Investigational Site
Bruxelles, , 1070, Belgium
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Contact
1-800-718-1021
[email protected]
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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hepatitis C
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- HCV RNA ≥ 100,000 IU/mL at screening

- Genotype 1a or 1b

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Current or prior treatment with IFN and/or RBV


- Evidence of decompensated liver disease

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase 1 Study Of PF-00868554 In Hepatitis C Virus (HCV) Positive Patients
Official Title  ICMJE A Phase 1, Randomized, Double Blind (3rd Party Open), Placebo-controlled, Sequential Group, Multicentre Study To Evaluate The Multiple Dose Safety, Tolerability, Pharmacokinetics And Pharmacodynamics, of PF-00868554 in Hepatitis C Virus (HCV) Positive Otherwise Healthy Patient Volunteers
Brief Summary Assess the safety, tolerability and pharmacokinetics of multiple oral doses of PF-00868554 in HCV positive patient volunteers
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Drug: PF-00868554
    300 mg BID
  • Drug: PF-00868554
    450 mg BID
  • Drug: PF-00868554
    100 mg BID
  • Drug: PF-00868554
    300 mg TID
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: 2
    Intervention: Drug: PF-00868554
  • Experimental: 3
    Intervention: Drug: PF-00868554
  • Experimental: 1
    Intervention: Drug: PF-00868554
  • Experimental: 4
    Intervention: Drug: PF-00868554
  • Placebo Comparator: 5
    Intervention: Drug: Placebo
Publications * Wagner F, Thompson R, Kantaridis C, Simpson P, Troke PJ, Jagannatha S, Neelakantan S, Purohit VS, Hammond JL. Antiviral activity of the hepatitis C virus polymerase inhibitor filibuvir in genotype 1-infected patients. Hepatology. 2011 Jul;54(1):50-9. doi: 10.1002/hep.24342.

*   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
 (submitted: April 21, 2011)		32
Original Enrollment  ICMJE
 (submitted: March 7, 2007)		40
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HCV RNA ? 100,000 IU/mL at screening
  • Genotype 1a or 1b

Exclusion Criteria:

  • Current or prior treatment with IFN and/or RBV
  • Evidence of decompensated liver disease
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (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,   Germany,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00445315
Other Study ID Numbers  ICMJE A8121002
Has Data Monitoring Committee No
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
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP