NCT01226797

Safety And Efficacy Of Oral PF-4136309 In Patients With Chronic Hepatitis C Infection And Abnormal Liver Enzymes

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-04136309 500 MG BID IN SUBJECTS WITH CHRONIC HCV INFECTION AND RAISED AMINOTRANSFERASES

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the effect of PF-04136309 in patients with chronic hepatitic C virus infection and abnormal liver enzymes.

Detailed description

Study recruitment was stopped on Dec 15, 2011 due to difficulty in enrolling the targeted number of patients. Subjects currently enrolled into the study will complete the study as per protocol. There were no safety concerns involved in the decision to stop enrollment. The new anticipated Last Subject Last Visit (LSLV) is February 2012.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Placebo	Take 4 capsules twice daily 12 hours apart with water. Swallow whole.
DRUG	PF-04136309	Take 4 capsules twice daily 12 hours apart with water. Swallow whole.

Timeline

• Start date: 2011-01-17
• Primary completion: 2012-02-09
• Completion: 2012-02-09
• First posted: 2010-10-22
• Last updated: 2023-07-27
• Results posted: 2023-07-27

Locations

10 sites across 5 countries: Hong Kong, India, Singapore, South Korea, Taiwan