Last updated: July 3, 2023
Sponsor: University of Guadalajara
Overall Status: Active - Recruiting
Phase
2
Condition
Liver Disorders
Hepatitis
Hyponatremia
Treatment
Prolonged-Release Pirfenidone
Clinical Study ID
NCT05542615
MINERVA
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with a history of Chronic Viral Hepatitis C, of all genotypes, demonstratedwith previous studies (positive viral load).
- History of treatment with direct acting antivirals (AAD).
- Demonstration of negative viral load at least 6 months after completing treatment withAAD, considered as sustained viral response (SVR).
- Fibrotest and / or Liver Elastography test with advanced liver fibrosis scores (F3-F4).
- Verification of advanced liver fibrosis in a liver biopsy.
- Patients with Child Pugh functional class A or B and in stable clinical conditions (without active variceal hemorrhage, ascites or refractory encephalopathy) withconsumption of drugs at stable doses in at least 30 days.
- 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
Exclusion Criteria:
- Child Pugh functional class C (≥ 10 points)
- Pregnancy and lactation.
- History of known allergy or hypersensitivity to PFD.
- Having participated in another clinical study in the 60 days prior to the start ofthis one.
- Hospitalization within 30 days prior to the start of administration of the medication.
- Co-existing liver pathology: alcohol cirrhosis, hemochromatosis, Wilson's disease, α-1-antitrypsin deficiency, amyloidosis, autoimmune hepatitis, and Primary BiliaryCholangitis).
- Concomitant systemic infection including viral hepatitis B, HIV, as well asrespiratory infections, urinary, digestive, cellulite, etc.
- Serious concomitant conditions such as Heart Failure, Respiratory Failure and ChronicKidney Failure.
- Malignant neoplasms including hepatocellular carcinoma. Patients with basal cellcarcinoma or those with malignancies with more than 5 years of inactivity may beconsidered for the study.
- Decompensated diabetes mellitus (defined as that with fasting blood glucose valuesgreater than 175 mg / dL and / or glycated hemoglobin greater than 8%).
- Uncontrolled hypertension despite medications (defined as systolic values ≥ 150 anddiastolic values ≥ 100 mmHg).
- Patients with active alcohol intake in the last 6 months.
- Use of drugs known as concomitant hepatoprotectors (ursodexosicolic acid,s-adenosyl-methionine, silymarin, among others).
- 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 theopinion of the main investigator, may interfere with the study.
- Any other clinical condition that in the opinion of the main investigator couldcompromise the safety and well-being of the patient or jeopardize the conduct of thestudy.
Study Design
Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Prolonged-Release Pirfenidone
Phase: 2
Study Start date:
August 01, 2019
Estimated Completion Date:
January 01, 2024
Study Description
Connect with a study center
Institute for Molecular Biology in Medicine and Gene Therapy, CUCS, UdeG
Guadalajara, Jalisco 44340
MexicoSite Not Available
Hospital Central Militar
Mexico City, 11200
MexicoActive - Recruiting
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