Trial record 1 of 1 for:
A8121007
A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00720434
First received: July 18, 2008
Last updated: June 3, 2011
Last verified: June 2011
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Purpose
The purpose of this study is to further assess the potency of PF-00868554, an HCV polymerase inhibitor, in subjects chronically infected with HCV by evaluating the antiviral activity of PF-00868554 in combination with current standard of care therapy, pegylated interferon-alpha2a (PEGASYS) and ribavirin (COPEGUS).
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C |
Drug: PF-00868554 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Randomized, Placebo Controlled, Dose Ranging Study To Evaluate Peginterferon Alfa 2a (Pegasys®) And Ribavirin (Copegus®) With And Without PF-00868554 In Subjects Chronically Infected With Hepatitis C Virus |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- To assess the antiviral activity of PF-00868554 in combination with pegIFN-a and RBV over four weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To assess the safety and tolerability of PF-00868554 when administered in combination with pegIFN-a and RBV [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- To assess the pharmacokinetics of PF-00868554 when administered in combination with pegIFN-a and RBV [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- To assess the effect of four weeks of PF-00868554 therapy on long-term response to pegIFN-a/RBV therapy. [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 35 |
| Study Start Date: | August 2008 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
500 mg BID
|
Drug: PF-00868554
500 mg BID administered as 5x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks.
|
|
Experimental: B
300 mg BID
|
Drug: PF-00868554
300 mg BID administered as 3x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks
|
|
Experimental: C
200 mg BID
|
Drug: PF-00868554
200 mg BID administered as 2x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks
|
|
Placebo Comparator: D
Placebo
|
Drug: Placebo
Placebo administered for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Treatment naive (no prior treatment with IFN-a +/- RBV regimens.
- Subjects who have discontinued IFN-a containing regimens after <2 weeks of therapy due to tolerability issues are considered treatment naive.
- HCV RNA > 100,000 IU/mL at screening.
- Genotype 1.
- A diagnosis of chronic HCV infection for at least 6 months.
Exclusion Criteria:
- Evidence of acute or chronic infection with HIV or HBV.
- Exposure within the previous three months to an investigational anti-HCV agent.
- Evidence of severe or decompensated liver disease.
- Subjects with liver disease unrelated to HCV infection.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720434
Locations
| United States, California | |
| Pfizer Investigational Site | |
| La Jolla, California, United States, 92037 | |
| Pfizer Investigational Site | |
| San Francisco, California, United States, 94115 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Orlando, Florida, United States, 32803 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Springfield, Massachusetts, United States, 01107 | |
| United States, New York | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10021 | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10065 | |
| United States, Oklahoma | |
| Pfizer Investigational Site | |
| Tulsa, Oklahoma, United States, 74135 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Nashville, Tennessee, United States, 37205 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78215 | |
| Puerto Rico | |
| Pfizer Investigational Site | |
| Santurce, Puerto Rico, 00909 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00720434 History of Changes |
| Other Study ID Numbers: | A8121007 |
| Study First Received: | July 18, 2008 |
| Last Updated: | June 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Hepatitis, Chronic Peginterferon alfa-2a Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013