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

September 7, 2022 updated by: Pfizer

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong KOng, Hong Kong
        • The University of Hong Kong,
      • Prince Of Wales Hospital, Shatin, New Territories,, Hong Kong
        • The Chinese University of Hong Kong,
  • India
      • New Delhi, India, 110 070
        • Institute of Liver & Biliary Sciences
    • Karnataka
      • Bangalore, Karnataka, India, 560017
        • Manipal Hospital
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 012
        • Seth G. S. Medical College & King Edward Memorial Hospital,
  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital, Department of Internal Medicine
      • Seoul, Korea, Republic of, 120-752
        • Severance Hospital, Yonsei University College of Medicine, Division of Gastroenterology
  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Chung-Ho Memorial Hospital, Kaohsiung Medical University
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a Response in Serum Alanine Aminotransferase (ALT) Level at Week 4
Time Frame: Week 4
Responder was defined as a participant who experienced reduction in ALT of greater than or equal to (>=) 30 percent (%) of the baseline value. Baseline ALT value was defined as mean of measurements collected at screening visits 1 and 2 and pre-dose Day 1. ALT levels were determined at central lab.
Week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a Response in Serum Aspartate Aminotransferase (AST) Level From Baseline at Week 4
Time Frame: Week 4
AST responder status was defined as a reduction in AST >= 30% of the baseline value and or normalization. Baseline AST level was defined as the mean of measurements collected on screening visit 1 and pre-dose Day 1. AST levels were determined at central lab.
Week 4
Change From Baseline in Serum ALT at Weeks 1, 2, 3 and 4
Time Frame: Baseline, Weeks 1, 2, 3 and 4
Baseline ALT value was defined as mean of measurements collected at screening visits 1 and 2 and pre-dose Day 1.
Baseline, Weeks 1, 2, 3 and 4
Serum ALT at Baseline
Time Frame: Baseline
Baseline ALT level was defined as the mean of measurements collected on Screening visits 1 and 2 and pre-dose Day 1.
Baseline
Change From Baseline in Serum AST at Weeks 1, 2, 3 and 4
Time Frame: Baseline, Weeks 1, 2, 3 and 4
Baseline AST level was defined as the mean of measurements collected on screening visit 1 and pre-dose Day 1.
Baseline, Weeks 1, 2, 3 and 4
Serum AST at Baseline
Time Frame: Baseline
Baseline AST level was defined as the mean of measurements collected on screening visit 1 and pre-dose Day 1.
Baseline
Change From Baseline in Methacetin Breath Test (BreathID) at Weeks 1 and 4
Time Frame: Baseline, Weeks 1 and 4
After drinking 13ˆC-methacetin, participants breath was collected using a BreathID® collection system for approximately 60 minutes and the ratio of 13ˆCO2:12ˆCO2 were determined to monitor the function of the liver. Results to be reported in ratio.
Baseline, Weeks 1 and 4
Change From Baseline in Enhanced Liver Fibrosis Test (ELF) at Week 4
Time Frame: Baseline, Week 4
Markers of fibrosis assessed in the ELF test comprise hyaluronic acid (HA), tissue inhibitor of matrix metalloproteinase 1 (TIMP-1), and amino terminal peptide of pro-collagen III (PIIINP). The HA ranges from 0 to 1000 in ng/mL; the TIMP-1 ranges from 0 to 3000 ng/mL; and the PIIINP tissue ranges from 0 to 151 in nanograms/milliliter (ng/mL). ELF algorithm calculates a discriminant score (DS) specified by DS = -7.412 plus (+) 0.681 times (*)ln(HA)+ 0.494 * ln(TIMP1)+ 0.775 * ln(PIIINP). Results to be reported in discriminant score.
Baseline, Week 4
Maximum Observed Plasma Concentration (Cmax) of PF-04136309
Time Frame: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post-dose on Day 28
Cmax was defined as maximum observed plasma concentration of PF-04136309.
Pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post-dose on Day 28
Plasma Decay Half-Life (t1/2) of PF-04136309
Time Frame: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post-dose on Day 28
Plasma decay half-life was the time measured for the plasma concentration to decrease by one half.
Pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post-dose on Day 28
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04136309
Time Frame: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post-dose on Day 28
AUCtau was defined as area under the concentration curve from time zero to end of dosing interval of PF-04136309.
Pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post-dose on Day 28
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04136309
Time Frame: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post-dose on Day 28
Tmax was defined as time to reach maximum observed plasma concentration of PF-04136309.
Pre-dose, 0.5, 1, 2, 4, 6, 8 and 12 hours post-dose on Day 28
Change From Baseline in Phosphorylated Extracellular Signal- Regulated Kinase (p-ERK) Levels at Week 2 and 4
Time Frame: Baseline, Week 2 and 4
p-ERK is a biomarker used to assess bioavailability of PF-04136309. Baseline p-ERK level defined as the last pre-dose measurement.
Baseline, Week 2 and 4
Baseline p-ERK
Time Frame: Baseline
p-ERK is a biomarker used to assess bioavailability of PF-04136309. Baseline p-ERK level defined as the last pre-dose measurement.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 17, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 9, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 9, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2010

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A9421016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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