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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 May 10, 2018

FOR MORE INFORMATION
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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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
This study will evaluate the effect of PF-04136309 in patients with chronic hepatitic C virus infection and abnormal liver enzymes.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hepatitis C, Chronic
  • 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.
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: PF-04136309
    Intervention: Drug: PF-04136309
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
February 2012
February 2012   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong,   India,   Korea, Republic of,   Singapore,   Taiwan
 
 
NCT01226797
A9421016
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2012

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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