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Phase 1 Study To Evaluate Antiviral Activity Of Small Molecule Direct Antiviral Agent At Multiple Doses In Subjects With Chronically Infected Hepatitis C Virus.

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NCT00671671

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Gainesville, Florida, 32608 United States
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.
Chronic Hepatitis, Hepatitis C Virus
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 Positive With HCV RNA>100,000 iu/ml Genotype 1; COHORT A- non responders or partial

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

HIV HBV co-infection Decompensated liver disease Liver disease due to causes other than
HCV, AFP>200ng/ml

NCT00671671
Pfizer
Completed
Phase 1 Study To Evaluate Antiviral Activity Of Small Molecule Direct Antiviral Agent At Multiple Doses In Subjects With Chronically Infected Hepatitis C Virus.

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Phase 1 Study To Evaluate Antiviral Activity Of Small Molecule Direct Antiviral Agent At Multiple Doses In Subjects With Chronically Infected Hepatitis C Virus.
A Phase 1, Non- Randomized, Open Label, Sequential Group, Multicenter Study To Evaluate The Antiviral Activity Of Multiple Doses Of A Small Molecule Direct Antiviral Agent In Chronically Infected Hepatitis C Subjects.
Phase 1 study in HVC (Hepatitis C Virus) infected subjects to determine pharmacokinetics, safety and efficacy in subjects with no or inadequate response to prior treatment.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hepatitis, Chronic
  • Hepatitis C Virus
  • Drug: Small Molecule Agent (PF-868554)
    Study drug will be administered 700mg BID in the fed state for three days.
  • Drug: Small Molecule Agent (PF-868554)
    Study drug will be given 450mg BID for a duration of 10 days.
  • Experimental: Cohort B
    Intervention: Drug: Small Molecule Agent (PF-868554)
  • Experimental: Cohort A
    Dose study drug in subjects who have previously failed to respond to interferon based therapies
    Intervention: Drug: Small Molecule Agent (PF-868554)
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
20
December 2008
December 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

HCV Positive With HCV RNA>100,000 iu/ml Genotype 1; COHORT A- non responders or partial

Exclusion Criteria:

HIV HBV co-infection Decompensated liver disease Liver disease due to causes other than HCV, AFP>200ng/ml
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
Germany
 
NCT00671671
A8121006
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2013

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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