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

NCT01226797 | Terminated Phase 2 Results

• 1 other identifier: A9421016
• Study Type: interventional
• Target: 24
• Locations: 5 countries
• Sites: 10

Brief Summary

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

Conditions

Hepatitis C, Chronic

Keywords

Chronic HCV infection; raised ALT; transaminitis; HCV infection

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 4

Secondary Outcomes (13)

• Percentage of Participants With a Response in Serum Aspartate Aminotransferase (AST) Level From Baseline at Week 4

  Week 4

• Change From Baseline in Serum ALT at Weeks 1, 2, 3 and 4

  Baseline, Weeks 1, 2, 3 and 4

• Serum ALT at Baseline

  Baseline

• Change From Baseline in Serum AST at Weeks 1, 2, 3 and 4

  Baseline, Weeks 1, 2, 3 and 4

• Serum AST at Baseline

  Baseline

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

PF-04136309

ACTIVE COMPARATOR

Drug: PF-04136309

Interventions

Placebo DRUG

Take 4 capsules twice daily 12 hours apart with water. Swallow whole.

Placebo

PF-04136309 DRUG

Take 4 capsules twice daily 12 hours apart with water. Swallow whole.

PF-04136309

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (10)

The Chinese University of Hong Kong,

Prince of Wales Hospital, Shatin, New Territories,, Hong Kong, 0, Hong Kong

Location

The University of Hong Kong,

Hong Kong, 0, Hong Kong

Location

Manipal Hospital

Bangalore, Karnataka, 560017, India

Location

Seth G. S. Medical College & King Edward Memorial Hospital,

Mumbai, Maharashtra, 400 012, India

Location

Institute of Liver & Biliary Sciences

New Delhi, 110 070, India

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

Seoul National University Hospital, Department of Internal Medicine

Seoul, 110-744, South Korea

Location

Severance Hospital, Yonsei University College of Medicine, Division of Gastroenterology

Seoul, 120-752, South Korea

Location

Chung-Ho Memorial Hospital, Kaohsiung Medical University

Kaohsiung City, 807, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

PF-04136309

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2010
• First Posted: October 22, 2010
• Study Start: January 17, 2011
• Primary Completion: February 9, 2012
• Study Completion: February 9, 2012
• Last Updated: July 27, 2023
• Results First Posted: July 27, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

IN (3); SG (1); HK (2); KR (2); TW (2)