A Phase 1 Study Of PF-00868554 In Hepatitis C Virus (HCV) Positive Patients
NCT00445315
Last updated date
ABOUT THIS STUDY
Assess the safety, tolerability and pharmacokinetics of multiple oral doses of PF-00868554 in
HCV positive patient volunteers
FOR MORE INFORMATION
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Eligibility Criteria
condition
Hepatitis C
Sex
Females and Males
Age
18-65 years
Inclusion Criteria
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- HCV RNA ≥ 100,000 IU/mL at screening
- Genotype 1a or 1b
Exclusion Criteria
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- 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 |
| |||
Study Arms ICMJE |
| |||
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 | 32 | |||
Original Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |