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

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NCT00445315

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bruxelles, , 1070 Belgium
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NCT00445315
Pfizer
Completed
A Phase 1 Study Of PF-00868554 In Hepatitis C Virus (HCV) Positive Patients

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A Phase 1 Study Of PF-00868554 In Hepatitis C Virus (HCV) Positive Patients
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
Assess the safety, tolerability and pharmacokinetics of multiple oral doses of PF-00868554 in HCV positive patient volunteers
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Hepatitis C
  • 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
  • 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
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.
 
Completed
32
June 2008
June 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany,   United Kingdom
 
 
NCT00445315
A8121002
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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