Hepatitis C, ChronicPhase 2NCT01226797

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

A Phase 2 study testing PF-04136309 in people with Hepatitis C, Chronic, run by Pfizer at 10 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

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

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: PF-04136309
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 10 sitesin 5 countries
Study dates: 17 Jan 2011to 9 Feb 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chronic HCV infection
ALT >1.5 but <10 times upper limit of normal

Who cannot join

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.

Show all 10Show fewer

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).

Trial locations and contacts

10 sites in 5 countries.

Country

City, postcode or hospital

10 sites in 5 countries

India3 sites

Manipal Hospital
Bangalore, Karnataka, 560017
Seth G. S. Medical College & King Edward Memorial Hospital,
Mumbai, Maharashtra, 400 012
Institute of Liver & Biliary Sciences
New Delhi, 110 070

Other trials in India

Hong Kong2 sites

The University of Hong Kong,
Hong Kong, 0
The Chinese University of Hong Kong,
Prince of Wales Hospital, Shatin, New Territories,, Hong Kong, 0

Other trials in Hong Kong

South Korea2 sites

Seoul National University Hospital, Department of Internal Medicine
Seoul, 110-744
Severance Hospital, Yonsei University College of Medicine, Division of Gastroenterology
Seoul, 120-752

Other trials in South Korea

Taiwan2 sites

Chung-Ho Memorial Hospital, Kaohsiung Medical University
Kaohsiung City, 807
National Taiwan University Hospital
Taipei, 100

Other trials in Taiwan

Singapore1 site

Singapore General Hospital
Singapore, 169608

Other trials in Singapore

About this study

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

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

Read the 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.

Conditions: Hepatitis C, Chronic
Being tested: Placebo, PF-04136309
Keywords: Chronic HCV infection, raised ALT, transaminitis, HCV infection
Medical subject headings: Hepatitis C, Chronic, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Take 4 capsules twice daily 12 hours apart with water. Swallow whole.
PF-04136309Drug
Take 4 capsules twice daily 12 hours apart with water. Swallow whole.

Study groups in NCT01226797
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
PF-04136309	Active comparator	Not described Receives: Drug: PF-04136309

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With a Response in Serum Alanine Aminotransferase (ALT) Level at 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.
Measured: Week 4

Secondary outcomes (13)

Percentage of Participants With a Response in Serum Aspartate Aminotransferase (AST) Level From Baseline at 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.
Measured: Week 4
Change From Baseline in Serum ALT at 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.
Measured: Baseline, Weeks 1, 2, 3 and 4
Serum ALT at Baseline
Baseline ALT level was defined as the mean of measurements collected on Screening visits 1 and 2 and pre-dose Day 1.
Measured: Baseline
Change From Baseline in Serum AST at 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.
Measured: Baseline, Weeks 1, 2, 3 and 4
Serum AST at Baseline
Baseline AST level was defined as the mean of measurements collected on screening visit 1 and pre-dose Day 1.
Measured: Baseline
Change From Baseline in Methacetin Breath Test (BreathID) at 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.
Measured: Baseline, Weeks 1 and 4
Change From Baseline in Enhanced Liver Fibrosis Test (ELF) at 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.
Measured: Baseline, Week 4
Maximum Observed Plasma Concentration (Cmax) of PF-04136309
Cmax was defined as maximum observed plasma concentration of PF-04136309.
Measured: 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
Plasma decay half-life was the time measured for the plasma concentration to decrease by one half.
Measured: 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
AUCtau was defined as area under the concentration curve from time zero to end of dosing interval of PF-04136309.
Measured: 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
Tmax was defined as time to reach maximum observed plasma concentration of PF-04136309.
Measured: 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
p-ERK is a biomarker used to assess bioavailability of PF-04136309. Baseline p-ERK level defined as the last pre-dose measurement.
Measured: Baseline, Week 2 and 4
Baseline p-ERK
p-ERK is a biomarker used to assess bioavailability of PF-04136309. Baseline p-ERK level defined as the last pre-dose measurement.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jan 20119 Feb 2012

First posted22 Oct 2010 (estimated)
Study start17 Jan 2011
Primary completion9 Feb 2012
Study completion9 Feb 2012

Why it stopped: See termination reason in detailed description.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01226797
Sponsor's protocol ID: A9421016
Status last verified: Sep 2022
First submitted: 21 Oct 2010
Last updated: 27 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
Not yet recruitingPhase 2
A Study of HT-101 and HT-102 in Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Active, not recruitingPhase 4
Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelines
Chronic Hepatitis b

All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01226797
Acronym / sponsor ID: A9421016
Conditions: Hepatitis C, Chronic
Keywords: Chronic HCV infection, raised ALT, transaminitis, HCV infection
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: See termination reason in detailed description.
Enrolment: 24 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 17 Jan 2011 (actual)
Primary completion: 9 Feb 2012 (actual)
Study completion: 9 Feb 2012 (actual)
First posted: 22 Oct 2010 (estimated)
Results: Posted 27 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
PF-04136309	Active comparator	Drug: PF-04136309

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Chronic HCV infection
ALT >1.5 but <10 times upper limit of normal

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboTake 4 capsules twice daily 12 hours apart with water. Swallow whole.	Drug	Placebo
PF-04136309Take 4 capsules twice daily 12 hours apart with water. Swallow whole.	Drug	PF-04136309

Primary outcome

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.

13 secondary outcomes

Percentage of Participants With a Response in Serum Aspartate Aminotransferase (AST) Level From Baseline at Week 4
Time frame: Week 4
Change From Baseline in Serum ALT at Weeks 1, 2, 3 and 4
Time frame: Baseline, Weeks 1, 2, 3 and 4
Serum ALT at Baseline
Time frame: Baseline
Change From Baseline in Serum AST at Weeks 1, 2, 3 and 4
Time frame: Baseline, Weeks 1, 2, 3 and 4
Serum AST at Baseline
Time frame: Baseline
Change From Baseline in Methacetin Breath Test (BreathID) at Weeks 1 and 4
Time frame: Baseline, Weeks 1 and 4
Change From Baseline in Enhanced Liver Fibrosis Test (ELF) at Week 4
Time frame: 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
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
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
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
Change From Baseline in Phosphorylated Extracellular Signal- Regulated Kinase (p-ERK) Levels at Week 2 and 4
Time frame: Baseline, Week 2 and 4
Baseline p-ERK
Time frame: Baseline

Results and safety

Results posted to the registry on 27 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PF-04136309	12	10
Placebo	12	11

Primary outcome: Percentage of Participants With a Response in Serum Alanine Aminotransferase (ALT) Level at Week 4

Time frame: Week 4. Number. Unit: Percentage of participants

Measure	PF-04136309 n = 12	Placebo n = 11
Value	25.00	36.36

PF-04136309 vs Placebo: Odds Ratio (OR): 0.5834 (95% CI 0.10 to 3.51), p = 0.6668, Fisher Exact

Population analysed: Full Analysis Set (FAS): all randomized participants who had a baseline value and at least 1 post-baseline value. Missing data was imputed using last observation carried forward (LOCF).

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PF-04136309	2 of 12 (16.7%)	8 of 12 (66.7%)	Not reported
Placebo	0 of 12 (0%)	3 of 12 (25%)	Not reported

Limitations and caveats (from the sponsor): Study recruitment stopped early due to difficulty in enrolling enough participants. Study terminated early due to a recommendation to terminate further development of PF-04136309 in this indication.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

Related trials for Hepatitis C, Chronic

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
Not yet recruitingPhase 2
A Study of HT-101 and HT-102 in Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Active, not recruitingPhase 4
Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelines
Chronic Hepatitis b

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

10 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-04136309 in people with Hepatitis C, Chronic, run by Pfizer at 10 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in India, Hong Kong, South Korea, Taiwan, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With a Response in Serum Alanine Aminotransferase (ALT) Level at Week 4 (time frame: Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01226797.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.