A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00720434
• Other study ID #: A8121007
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2008
• Last updated: June 18, 2013
• Start date: August 2008
• Est. completion date: March 2010

Study information

• Verified date: June 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

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.
• 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
• 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
Placebo administered for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks

Locations

Country	Name	City	State
Puerto Rico	Pfizer Investigational Site	Santurce
United States	Pfizer Investigational Site	La Jolla	California
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	Springfield	Massachusetts
United States	Pfizer Investigational Site	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set	Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 international unit per milliliter [IU/mL]). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.	Baseline, Week 4	No
Primary	Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set	Plasma HCV RNA levels were measured using the Roche COBAS Taqman assay (limit of detection: 25 IU/mL). Baseline value calculated as the average of the screening and Day 1 pre-dose measurements.	Baseline, Week 4	No
Secondary	Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)	Proportion of participants achieving undetectable plasma HCV RNA at Week 4 (rapid virologic response), at Week 12 (early virologic response), at Week 48 (end of treatment response), at Week 60 (sustained virologic response; 12 weeks after cessation of therapy), at Week 72 (sustained virologic response; 24 weeks after cessation of therapy) were summarized. Undetectable viral load was defined as HCV RNA <25 IU/mL.	Week 4, 12, 48, 60, 72	No
Secondary	Alanine Aminotransferase (ALT) Levels		Week 4, 12, 48, 72	No
Secondary	Population Pharmacokinetics (PK) of PF-00868554	Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.	1, 2 and 6 hours post-dose on Day 1; 0 hour (pre-dose) on Day 7, 14, 21; 0 hour (pre-dose), 2, 6 hours post-dose on Day 28	No

External Links

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