Back to resultsPirfenidone, an Antifibrotic and Antiinflammatory Drug
Primary Purpose
Fibrosis, Hepatitis C Chronic
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pirfenidone
Matched equivalent placebo
Sponsored by
About this trial
This is an interventional treatment trial for Fibrosis focused on measuring Fibrosis, necroinflammation, hepatitis C chronic
Eligibility Criteria
Inclusion Criteria:
- Patients with established advanced liver disease caused by hepatitis C virus (HCV) chronic infection defined by a positive test for anti-HCV antibodies and detectable serum HCV RNA (Amplicor HCV 2.0 polymerase chain reaction (PCR) assay).
- Sign an informed consent form to allow the collection of liver biopsies before and after treatment.
- No antifibrotic, antiviral or immunosuppressive drugs for at least 6 months before starting pirfenidone therapy.
- No alcohol intake for at least 6 months before nor during Pirfenidone (PFD) treatment.
Exclusion Criteria:
- Patients with clinical contraindications to hepatic biopsy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Pirfenidone
Matched equivalent placebo
Arm Description
Pirfenidone 400 mg capsules, orally administered thrice daily to yield a daily dose of 1200 mg during two years.
Matched equivalent placebo
Outcomes
Primary Outcome Measures
Fibrosis staging
Fibrosis was evaluated according to Ishak fibrosis staging scale.
Secondary Outcome Measures
Grade of necroinflammation activity
Necroinflammatory activity was evaluated according to the Ishak modified histological activity index (HAI).
Full Information
NCT ID
NCT02161952
First Posted
June 10, 2014
Last Updated
July 7, 2014
Sponsor
University of Guadalajara
Collaborators
Cell Therapy And Technology, S.a. De C.v.
1. Study Identification
Unique Protocol Identification Number
NCT02161952
Brief Title
Pirfenidone, an Antifibrotic and Antiinflammatory Drug
Official Title
Pirfenidone, an Antifibrotic and Antiinflammatory Drug for Treatment of Patients With Cirrhosis Due to Hepatitis C Virus. Phase II/III Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guadalajara
Collaborators
Cell Therapy And Technology, S.a. De C.v.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study was to assess whether two-year treatment with Pirfenidone influence necro-inflammation, fibrosis and steatosis in patients with chronic hepatitis C.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrosis, Hepatitis C Chronic
Keywords
Fibrosis, necroinflammation, hepatitis C chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pirfenidone
Arm Type
Experimental
Arm Description
Pirfenidone 400 mg capsules, orally administered thrice daily to yield a daily dose of 1200 mg during two years.
Arm Title
Matched equivalent placebo
Arm Type
Placebo Comparator
Arm Description
Matched equivalent placebo
Intervention Type
Drug
Intervention Name(s)
Pirfenidone
Other Intervention Name(s)
5 methyl-1-phenil-2 (1H)-pyridone
Intervention Description
Pirfenidone was supplied orally in 400 mg gel capsules three times daily (every 8 hours) for a full dosage of 1200 mg daily during 24 months.
Intervention Type
Drug
Intervention Name(s)
Matched equivalent placebo
Primary Outcome Measure Information:
Title
Fibrosis staging
Description
Fibrosis was evaluated according to Ishak fibrosis staging scale.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Grade of necroinflammation activity
Description
Necroinflammatory activity was evaluated according to the Ishak modified histological activity index (HAI).
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with established advanced liver disease caused by hepatitis C virus (HCV) chronic infection defined by a positive test for anti-HCV antibodies and detectable serum HCV RNA (Amplicor HCV 2.0 polymerase chain reaction (PCR) assay).
Sign an informed consent form to allow the collection of liver biopsies before and after treatment.
No antifibrotic, antiviral or immunosuppressive drugs for at least 6 months before starting pirfenidone therapy.
No alcohol intake for at least 6 months before nor during Pirfenidone (PFD) treatment.
Exclusion Criteria:
Patients with clinical contraindications to hepatic biopsy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Armendariz-Borunda, Ph. D.
Organizational Affiliation
Head, Molecular Biology and Genomics Department
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
25064094
Citation
Flores-Contreras L, Sandoval-Rodriguez AS, Mena-Enriquez MG, Lucano-Landeros S, Arellano-Olivera I, Alvarez-Alvarez A, Sanchez-Parada MG, Armendariz-Borunda J. Treatment with pirfenidone for two years decreases fibrosis, cytokine levels and enhances CB2 gene expression in patients with chronic hepatitis C. BMC Gastroenterol. 2014 Jul 27;14:131. doi: 10.1186/1471-230X-14-131.
Results Reference
derived
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Pirfenidone, an Antifibrotic and Antiinflammatory Drug
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