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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01226797
First received: October 21, 2010
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Hepatitis C, Chronic
Drug: Placebo
Drug: PF-04136309
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in serum ALT. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the methacetin breath test (BreathID®). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the Enhanced Liver Fibrosis Test (ELF). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Plasma concentrations of PF-04136309 at each visit to support the development of a population PK model in chronic HCV patients. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in p-ERK levels. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: December 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01226797

Locations
Hong Kong
Pfizer Investigational Site
Hong KOng, Hong Kong, 0
Pfizer Investigational Site
Prince of Wales Hospital, Shatin, New Territories,, Hong Kong, 0
India
Pfizer Investigational Site
Bangalore, Karnataka, India, 560017
Pfizer Investigational Site
Mumbai, Maharashtra, India, 400 012
Pfizer Investigational Site
New Delhi, India, 110 070
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 120-752
Singapore
Pfizer Investigational Site
Singapore, Singapore, 169608
Taiwan
Pfizer Investigational Site
Kaohsiung, Taiwan, 807
Pfizer Investigational Site
Taipei, Taiwan, 100
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01226797     History of Changes
Other Study ID Numbers: A9421016
Study First Received: October 21, 2010
Last Updated: March 19, 2012
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by Pfizer:
Chronic HCV infection
raised ALT
transaminitis
HCV infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic

ClinicalTrials.gov processed this record on October 19, 2014