Phase 1 Study To Evaluate Antiviral Activity Of Small Molecule Direct Antiviral Agent At Multiple Doses In Subjects With Chronically Infected Hepatitis C Virus.
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00671671
First received: April 25, 2008
Last updated: January 13, 2009
Last verified: January 2009
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Purpose
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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change from baseline in plasma hcv rna for each treatment group and dosing regimes studied [ Time Frame: NADIR to day 11 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety, tolerability and pharmacokinetics for each treatment group and dosing regimen studied [ Time Frame: Day 0 to day 11 ] [ Designated as safety issue: Yes ]
| 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 |
|---|---|
| Experimental: Cohort B |
Drug: Small Molecule Agent (PF-868554)
Study drug will be administered 700mg BID in the fed state for three days.
|
|
Experimental: Cohort A
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
Additional Information:
No publications provided by Pfizer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00671671 History of Changes |
| Other Study ID Numbers: | A8121006 |
| Study First Received: | April 25, 2008 |
| Last Updated: | January 13, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013