Status:
COMPLETED
Pirfenidone and Advanced Liver Fibrosis.
Lead Sponsor:
Grupo Mexicano para el Estudios de las Enfermedades Hepaticas
Conditions:
Liver Fibrosis
Chronic Liver Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Pirfenidone (PFD), an oral antifibrotic drug with anti-inflammatory and anti-oxidant properties, has been granted marketing authorization by the European Medicine Agency and FDA, for the treatment of ...
Detailed Description
The study will be conducted in compliance with International Standard good clinical practices (GCPs) and the Declaration of Helsinki. The protocol was approved by local Institutional Review Board and ...
Eligibility Criteria
Inclusion
- Patients with chronic liver disease whose fibrosis continued to progress despite abstaining from alcohol (ALD), achieving sustained virologic response (VHC), or otherwise maintaining stable disease (NAFLD, AIH)..
- Advanced liver fibrosis defined as fibrosis grade 3 or grade 4 according to METAVIR scale based in two non-invasive liver fibrosis evaluation methods (FibroScan and Fibrotest).
- Stable liver disease.
Exclusion
- Patients with mild fibrosis (F1-F2)
- Under medication with colchicine, silymarin, non-steroidal anti-inflammatory drugs, and any hepatotoxic drug.
- Decompensation based on a history of hepatic encephalopathy, esophageal variceal bleeding, or ascites in the previous 6 months
- HIV, Hepatitis B virus (HBV) or any active infectious processes not of a self-limited nature.
- Concomitant or prior history of malignancy other than curatively-treated skin cancer or surgically-cured in situ carcinoma of the cervix.
- Hemoglobinopathy or any disease associated with hemolysis.
- History of significant cardiac or pulmonary disease that could be exacerbated by anemia.
- Liver masses detected by baseline scanner or Alpha-fetoprotein \>100 ng/L.
- Pregnancy.
- Alcohol or intravenous drug abuse within the previous year.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT04099407
Start Date
August 1 2019
End Date
December 31 2020
Last Update
April 2 2024
Active Locations (1)
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1
Liver Clinic 1
Mexico City, Mexico