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

Sponsor

Pfizer (Industry)

Overall Status

Terminated

CT.gov ID

NCT01226797

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

2.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C, Chronic	Drug: Placebo Drug: PF-04136309	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo Take 4 capsules twice daily 12 hours apart with water. Swallow whole.
Active Comparator: PF-04136309	Drug: PF-04136309 Take 4 capsules twice daily 12 hours apart with water. Swallow whole.

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Drug: Placebo

Take 4 capsules twice daily 12 hours apart with water. Swallow whole.

Active Comparator: PF-04136309

Drug: PF-04136309

Take 4 capsules twice daily 12 hours apart with water. Swallow whole.

Outcome Measures

Primary Outcome Measures

Responder status in serum ALT levels in subjects with chronic hepatitis C virus infection as measured at Week 4 of the study. A responder will be defined as a subject who experiences a reduction in ALT of greater or equal to 30% of the baseline value. [4 weeks]

Secondary Outcome Measures

Responder status in serum AST levels in subjects with chronic hepatitis C virus (HCV) infection as measured at Week 4 of the study. [4 weeks]
Change from baseline in serum ALT. [4 weeks]
Change from baseline in the methacetin breath test (BreathID®). [4 weeks]
Change from baseline in the Enhanced Liver Fibrosis Test (ELF). [4 weeks]
Plasma concentrations of PF-04136309 at each visit to support the development of a population PK model in chronic HCV patients. [4 weeks]
Change from baseline in p-ERK levels. [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Chronic HCV infection
ALT >1.5 but <10 times upper limit of normal

Exclusion Criteria:

Decompensated or severe liver disease defined by one or more of the following criteria:

Prior liver biopsy showing cirrhosis.

International Normalized Ratio (INR) greater than or equal to 1.5.
Total bilirubin greater than or equal to 1.5X ULN, or >2X ULN for unconjugated bilirubin.
Serum albumin below normal.
ALT or aspartate aminotransferase (AST) >10 x ULN.
Evidence of portal hypertension including splenomegaly, ascites, encephalopathy, and/or esophageal varices.
Presence of human immunodeficiency virus (HIV).
Co-infection with hepatitis B virus (HBV).
Co-infection with Epstein Barr Virus (EBV) and/or Cytomegalovirus (CMV).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Hong KOng		Hong Kong	0
2	Pfizer Investigational Site	Prince of Wales Hospital, Shatin, New Territories,		Hong Kong	0
3	Pfizer Investigational Site	Bangalore	Karnataka	India	560017
4	Pfizer Investigational Site	Mumbai	Maharashtra	India	400 012
5	Pfizer Investigational Site	New Delhi		India	110 070
6	Pfizer Investigational Site	Seoul		Korea, Republic of	110-744
7	Pfizer Investigational Site	Seoul		Korea, Republic of	120-752
8	Pfizer Investigational Site	Singapore		Singapore	169608
9	Pfizer Investigational Site	Kaohsiung		Taiwan	807
10	Pfizer Investigational Site	Taipei		Taiwan	100