Induction of Remission in Autoimmune Hepatitis With Azathioprine vs. MMF

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Oct 17, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two different medications, azathioprine (AZA) and mycophenolate mofetil (MMF), to see which one is better at helping patients with autoimmune hepatitis (AIH) go into remission. The researchers want to find out if MMF, when used with a steroid called prednisolone, helps more patients achieve normal liver function than AZA with prednisolone after 24 weeks. They will also compare the side effects of both treatments to see if one is safer than the other.

To participate in this study, you need to have a confirmed diagnosis of autoimmune hepatitis and have not received any prior treatment for this condition. Other important criteria include having elevated liver enzymes, being between certain age ranges, and being willing to follow the study guidelines. If you join the trial, you will receive either AZA or MMF along with prednisolone and will have regular check-ups to monitor your health, safety, and quality of life. This trial is not yet recruiting participants, but it's an opportunity to help find better treatments for autoimmune hepatitis.

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Eligibility criteria

• Inclusion Criteria:
• • Diagnosis: Confirmed diagnosis of autoimmune hepatitis (AIH) based on clinical, biochemical, and histological findings.
• • Biochemical markers: Elevated liver enzymes, specifically AST and ALT, indicating liver inflammation.
• • Treatment-naive: Patients must be treatment-naive, meaning they have not received prior immunosuppressive therapy for AIH.
• • Willingness to participate: Patients must provide informed consent and be willing to comply with all study-related procedures and follow-ups. -
• Exclusion Criteria:
• • Acute liver failure: Patients presenting with acute liver failure at baseline will be excluded.
• • Other liver diseases: Co-existing liver conditions such as hepatitis B, hepatitis C, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), or any alcohol-induced liver disease will lead to exclusion.
• • Low blood counts: Patients with a platelet count less than 50,000/mm³ or total leukocyte count (TLC) less than 3,000/mm³ will not be eligible.
• • Previous treatment: Patients who have already received immunosuppressive or disease-modifying therapy for AIH or related conditions.
• • Pregnancy or lactation: Pregnant or lactating women will be excluded to avoid potential risks to the mother or fetus.
• • Hepatocellular carcinoma (HCC) or malignancy: Any patients with evidence of hepatocellular carcinoma or other active malignancies.
• • Medication allergies: Patients with known allergies to azathioprine, mycophenolate mofetil (MMF), or prednisolone will be excluded.
• • Non-consent: Patients who are not willing to participate in the study or unable to provide informed consent.