Prolonged Release Pirfenidone for Advanced Residual Liver Fibrosis (MINERVA).

Launched by UNIVERSITY OF GUADALAJARA · Sep 13, 2022

Keywords

ClinConnect Summary

The MINERVA clinical trial is studying a medication called Prolonged-Release Pirfenidone (PR-PFD) to see if it can help patients with advanced liver fibrosis, particularly those who have had chronic hepatitis C. This trial aims to understand how PR-PFD works in the body and whether it can improve liver health in patients who have successfully treated their hepatitis C but still have significant liver damage. The researchers are looking for participants who are between the ages of 65 and 74, have a history of hepatitis C, have shown a positive response to antiviral treatments, and have advanced liver fibrosis confirmed through tests.

Eligible participants will take two doses of PR-PFD daily while being closely monitored for safety and effectiveness. It’s important for potential participants to know that certain health conditions, such as severe liver issues or active infections, may prevent them from joining the study. If you qualify and decide to participate, you will be contributing to important research that could lead to better treatment options for people with liver conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with a history of Chronic Viral Hepatitis C, of all genotypes, demonstrated with previous studies (positive viral load).
• • 2. History of treatment with direct acting antivirals (AAD).
• • 3. Demonstration of negative viral load at least 6 months after completing treatment with AAD, considered as sustained viral response (SVR).
• • 4. Fibrotest and / or Liver Elastography test with advanced liver fibrosis scores (F3-F4).
• • 5. Verification of advanced liver fibrosis in a liver biopsy.
• • 6. Patients with Child Pugh functional class A or B and in stable clinical conditions (without active variceal hemorrhage, ascites or refractory encephalopathy) with consumption of drugs at stable doses in at least 30 days.
• 7. Laboratory tests that confirm her condition and functional class, with results that, in the opinion of the main researcher, do not put the patient at risk:
• • Complete blood count, with hemoglobin values ≥ 10 g / dL, leukocytes ≥ 3,000 mL, platelets ≥ 50,000 mL
• • Creatinine \<1.8 mg / dL
• Exclusion Criteria:
• • 1. Child Pugh functional class C (≥ 10 points)
• • 2. Pregnancy and lactation.
• • 3. History of known allergy or hypersensitivity to PFD.
• • 4. Having participated in another clinical study in the 60 days prior to the start of this one.
• • 5. Hospitalization within 30 days prior to the start of administration of the medication.
• • 6. Co-existing liver pathology: alcohol cirrhosis, hemochromatosis, Wilson's disease, α-1-antitrypsin deficiency, amyloidosis, autoimmune hepatitis, and Primary Biliary Cholangitis).
• • 7. Concomitant systemic infection including viral hepatitis B, HIV, as well as respiratory infections, urinary, digestive, cellulite, etc.
• • 8. Serious concomitant conditions such as Heart Failure, Respiratory Failure and Chronic Kidney Failure.
• • 9. Malignant neoplasms including hepatocellular carcinoma. Patients with basal cell carcinoma or those with malignancies with more than 5 years of inactivity may be considered for the study.
• • 10. Decompensated diabetes mellitus (defined as that with fasting blood glucose values greater than 175 mg / dL and / or glycated hemoglobin greater than 8%).
• • 11. Uncontrolled hypertension despite medications (defined as systolic values ≥ 150 and diastolic values ≥ 100 mmHg).
• • 12. Patients with active alcohol intake in the last 6 months.
• • 13. Use of drugs known as concomitant hepatoprotectors (ursodexosicolic acid, s-adenosyl-methionine, silymarin, among others).
• • 14. Patients with treatment of CYP1A2 inhibitor drugs or other CYP isoenzymes such as: fluvoxamine, amiodarone, fluconazole, chloramphenicol, fluoxentine, paroxentine, ciprofloxacin, rifampin or propafenone, or other medicinal products that, in the opinion of the main investigator, may interfere with the study.
• • 15. Any other clinical condition that in the opinion of the main investigator could compromise the safety and well-being of the patient or jeopardize the conduct of the study.