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

Phase 2

Completed

• Conditions: Hepatitis C
• Interventions: Drug: PF-00868554; Drug: Placebo

• Registration Number: NCT00720434
• Lead Sponsor: Pfizer

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-18
• Study First Submitted QC: 2008-07-21
• Study First Posted: 2008-07-22
• Study Start: 2008-08
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Disposition First Submitted: 2011-06-03
• Disposition First Submitted QC: 2011-06-03
• Disposition First Posted: 2011-06-16
• Status Verified: 2013-06
• Results First Submitted: 2013-06-18
• Results First Submitted QC: 2013-06-18
• Last Update Submitted: 2013-06-18
• Results First Posted: 2013-08-26
• Last Update Posted: 2013-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	PF-00868554	500 mg BID
B	PF-00868554	300 mg BID
C	PF-00868554	200 mg BID
D	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Full Analysis Set	Baseline, Week 4	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.
Change From Baseline in Plasma Log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 - Modified Analysis Set	Baseline, Week 4	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants Achieving Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)	Week 4, 12, 48, 60, 72	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.
Alanine Aminotransferase (ALT) Levels	Week 4, 12, 48, 72
Population Pharmacokinetics (PK) of PF-00868554	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	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇵🇷 Santurce, Puerto Rico