CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
PF-00868554 +3 moredrug
Likely dose
PF-00868554 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00720434
NCT00720434Phase 2Completed

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

Pfizer·interventional·Posted Jul 22, 2008·Updated Aug 26, 2013

In Brief

A Phase 2 clinical trial evaluating PF-00868554 and Placebo for Hepatitis C. Completed, enrolled 35 participants across 10 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 22, 2008
Enrollment StartAug 1, 2008
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.9 years ago

Interventions

PF-00868554drug

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-00868554drug

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-00868554drug

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

Placebodrug

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