Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Pfizer |
---|---|
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00671671 |
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.
Condition | Intervention | Phase |
---|---|---|
Hepatitis, Chronic Hepatitis C Virus |
Drug: Small Molecule Agent (PF-868554) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | 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. |
Enrollment: | 20 |
Study Start Date: | April 2008 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Cohort B: Experimental |
Drug: Small Molecule Agent (PF-868554)
Study drug will be administered 700mg BID in the fed state for three days.
|
Cohort A: Experimental
Dose study drug in subjects who have previously failed to respond to interferon based therapies
|
Drug: Small Molecule Agent (PF-868554)
Study drug will be given 450mg BID for a duration of 10 days.
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A8121006 |
Study First Received: | April 25, 2008 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00671671 |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis, Chronic Hepatitis, Viral, Human Hepatitis C |
RNA Virus Infections Flaviviridae Infections |