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Safety And Efficacy Of Oral PF-4136309 In Patients With Chronic Hepatitis C Infection And Abnormal Liver Enzymes | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

NCT01226797•Pfizer

View on ClinicalTrials.gov

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

Age

18 - 70 years

Sex

ALL

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).

Locations (10)

The Chinese University of Hong Kong,

Prince of Wales Hospital, Shatin, New Territories,, Hong Kong, Hong Kong

The University of Hong Kong,

Hong Kong, Hong Kong

Manipal Hospital

Bangalore, Karnataka, India

Seth G. S. Medical College & King Edward Memorial Hospital,

Mumbai, Maharashtra, India

Institute of Liver & Biliary Sciences

New Delhi, India

Singapore General Hospital

Singapore, Singapore

Seoul National University Hospital, Department of Internal Medicine

Seoul, South Korea

Severance Hospital, Yonsei University College of Medicine, Division of Gastroenterology

Seoul, South Korea

Chung-Ho Memorial Hospital, Kaohsiung Medical University

Kaohsiung City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Key Dates

Start Date

January 17, 2011

Primary Completion Date

February 9, 2012

Completion Date

February 9, 2012

Last Updated

July 27, 2023

Enrollment

ACTUAL participants

Conditions

Hepatitis C, Chronic

Interventions

Placebo

DRUG

PF-04136309

DRUG

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

NCT05870969

Carcinoma, HepatocellularHepatitis C, Chronic+3 more

View study

COMPLETEDPHASE4

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

NCT03987503

Hepatitis C, Chronic

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

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