Pirfenidone and Advanced Liver Fibrosis.

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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 idiopathic pulmonary fibrosis (IPF). However, few studies have focused on its clinical utilization in patients with advanced hepatic fibrosis. Therefore, Investigators aim to evaluate a prolonged-release PFD formulation (PR-PFD) plus standard of care management on disease progression in patients with advanced liver fibrosis (ALF).

Methods: Patients with diverse chronic liver disease etiology (alcohol-related, hepatitis B or C, autoimmune or fatty liver disease) will be screened with two non invasive liver fibrosis methods (Fibroscan®) and Fibro Test®) and those with ALF (F3 or F4) will be treated for at least 12 months with PR-PFD. Antifibrotic effects Will be assessed at 6 and 12 months; variations greater than 30% in estimated fibrosis scores or 1 point on the METAVIR scale will be considered clinically significant. PFD plasma levels, serum endothelin-1, IL6, TNFα and TGFβ1, Quality of life and fatigue scales will be evaluated. Parametric and non parametric statistics will be utilized and p values lower tan 5% will be considered clinically significant.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grupo Mexicano para el Estudios de las Enfermedades Hepaticas
• Treatments: Pirfenidone

Criteria

Inclusion Criteria:

1. 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)..

2. 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).

3. Stable liver disease.

Exclusion Criteria:

1. Patients with mild fibrosis (F1-F2)

2. Under medication with colchicine, silymarin, non-steroidal anti-inflammatory drugs, and any hepatotoxic drug.

3. Decompensation based on a history of hepatic encephalopathy, esophageal variceal bleeding, or ascites in the previous 6 months

4. HIV, Hepatitis B virus (HBV) or any active infectious processes not of a self-limited nature.

5. Concomitant or prior history of malignancy other than curatively-treated skin cancer or surgically-cured in situ carcinoma of the cervix.

6. Hemoglobinopathy or any disease associated with hemolysis.

7. History of significant cardiac or pulmonary disease that could be exacerbated by anemia.

8. Liver masses detected by baseline scanner or Alpha-fetoprotein >100 ng/L.

9. Pregnancy.

10. Alcohol or intravenous drug abuse within the previous year.