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

Last updated on November 14, 2019

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Study Location
Pfizer Investigational Site
Hong KOng, , 0 Hong Kong
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Hepatitis C
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Chronic HCV infection

- ALT >1.5 but

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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).

NCT01226797
Pfizer
Terminated
Safety And Efficacy Of Oral PF-4136309 In Patients With Chronic Hepatitis C Infection And Abnormal Liver Enzymes

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Descriptive Information
Brief Title  ICMJE Safety And Efficacy Of Oral PF-4136309 In Patients With Chronic Hepatitis C Infection And Abnormal Liver Enzymes
Official Title  ICMJE 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
Brief SummaryThis study will evaluate the effect of PF-04136309 in patients with chronic hepatitic C virus infection and abnormal liver enzymes.
Detailed DescriptionStudy 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C, Chronic
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: PF-04136309
    Intervention: Drug: PF-04136309
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 19, 2012)
24
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2010)
62
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion DateFebruary 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong,   India,   Korea, Republic of,   Singapore,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01226797
Other Study ID Numbers  ICMJE A9421016
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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