Clinical trial NCT01226797: Safety And Efficacy Of Oral PF-4136309 In Patients With Chronic Hepatitis C Infection And Abnormal Liver Enzymes
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Keywords: Chronic HCV infection
raised ALT
transaminitis
HCV infection
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-10-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Participants With a Response in Serum Alanine Aminotransferase (ALT) Level at Week 4
timeFrame: Week 4
Secondary outcomes:
measure: Percentage of Participants With a Response in Serum Aspartate Aminotransferase (AST) Level From Baseline at Week 4
timeFrame: Week 4
measure: Change From Baseline in Serum ALT at Weeks 1, 2, 3 and 4
timeFrame: Baseline, Weeks 1, 2, 3 and 4
measure: Serum ALT at Baseline
timeFrame: Baseline
measure: Change From Baseline in Serum AST at Weeks 1, 2, 3 and 4
timeFrame: Baseline, Weeks 1, 2, 3 and 4
measure: Serum AST at Baseline
timeFrame: Baseline
measure: Change From Baseline in Methacetin Breath Test (BreathID) at Weeks 1 and 4
timeFrame: Baseline, Weeks 1 and 4
measure: Change From Baseline in Enhanced Liver Fibrosis Test (ELF) at Week 4
timeFrame: Baseline, Week 4
measure: Maximum Observed Plasma Concentration (Cmax) of PF-04136309
timeFrame: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post-dose on Day 28
measure: Plasma Decay Half-Life (t1/2) of PF-04136309
timeFrame: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post-dose on Day 28
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04136309
timeFrame: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post-dose on Day 28
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04136309
timeFrame: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post-dose on Day 28
measure: Change From Baseline in Phosphorylated Extracellular Signal- Regulated Kinase (p-ERK) Levels at Week 2 and 4
timeFrame: Baseline, Week 2 and 4
measure: Baseline p-ERK
timeFrame: Baseline
Other outcomes:
Locations:
city: Hong KOng
country: Hong Kong
facility: The University of Hong Kong,
city: Prince Of Wales Hospital, Shatin, New Territories,
country: Hong Kong
facility: The Chinese University of Hong Kong,
city: Bangalore
country: India
facility: Manipal Hospital
state: Karnataka
city: Mumbai
country: India
facility: Seth G. S. Medical College & King Edward Memorial Hospital,
state: Maharashtra
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital, Department of Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine, Division of Gastroenterology
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Kaohsiung
country: Taiwan
facility: Chung-Ho Memorial Hospital, Kaohsiung Medical University
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: