Induction of Remission in Autoimmune Hepatitis With Azathioprine vs. MMF

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

November 1, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Autoimmune Hepatitis
Interventions
DRUG

Mycophenolate Mofetil + Prednisolone Participants will receive mycophenolate mofetil in combination.

Participants in this arm will receive mycophenolate mofetil (MMF) starting at 1,000 mg/day for the first two weeks, increasing to 2,000 mg/day thereafter. This will be combined with prednisolone, beginning at 40-60 mg/day, with a tapering dose to 5-10 mg/day after 4-8 weeks, depending on the patient's response. MMF works by inhibiting inosine monophosphate dehydrogenase, which decreases lymphocyte proliferation, thereby reducing immune-mediated liver damage in autoimmune hepatitis. Prednisolone, a corticosteroid, is included to control inflammation during the induction phase of treatment. This intervention lasts for 24 weeks, with monitoring for biochemical remission (normalization of liver enzymes and IgG levels) and adverse events to assess the treatment's safety and efficacy.

DRUG

Azathioprine + Prednisolone

In this arm, participants will receive azathioprine (AZA) starting at 50 mg/day for the first two weeks, followed by an increase to 100 mg/day. This dose will be combined with prednisolone, starting at 40-60 mg/day, with the dosage tapering to 5-10 mg/day after 4-8 weeks, depending on patient response. Azathioprine works as an immunosuppressive agent by inhibiting DNA synthesis in rapidly dividing immune cells, thereby reducing liver inflammation in autoimmune hepatitis. Prednisolone, a corticosteroid, is included to control inflammation during the initial treatment phase. The intervention lasts for 24 weeks with regular monitoring for biochemical remission, defined as normalization of liver enzymes (AST, ALT) and IgG levels, as well as the occurrence of adverse events to assess safety and tolerability.

All Listed Sponsors
lead

Institute of Liver and Biliary Sciences, India

OTHER

NCT06650124 - Induction of Remission in Autoimmune Hepatitis With Azathioprine vs. MMF | Biotech Hunter | Biotech Hunter