[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566049":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":25,"responsibleParty":36,"collaborators":25,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":25,"eligibilityCriteria":43,"healthyVolunteers":40,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":25,"studyType":50,"phases":51,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":62,"whyStopped":25,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":25},{"fullName":5,"class":6},"Institute of Liver and Biliary Sciences, India","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Azathioprine + Prednisolone Arm","ACTIVE_COMPARATOR","Azathioprine + Prednisolone Arm Participants will receive azathioprine (AZA) in combination with prednisolone as part of their treatment regimen.",[13],"Drug: Azathioprine + Prednisolone",{"label":15,"type":10,"description":16,"interventionNames":17},"Mycophenolate Mofetil + Prednisolone Arm","Mycophenolate Mofetil + Prednisolone Arm Participants will receive mycophenolate mofetil (MMF) in combination with prednisolone as part of their treatment regimen.",[18],"Drug: Mycophenolate Mofetil + Prednisolone Participants will receive mycophenolate mofetil in combination.",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"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\u002Fday for the first two weeks, increasing to 2,000 mg\u002Fday thereafter. This will be combined with prednisolone, beginning at 40-60 mg\u002Fday, with a tapering dose to 5-10 mg\u002Fday 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.",[15],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Azathioprine + Prednisolone","In this arm, participants will receive azathioprine (AZA) starting at 50 mg\u002Fday for the first two weeks, followed by an increase to 100 mg\u002Fday. This dose will be combined with prednisolone, starting at 40-60 mg\u002Fday, with the dosage tapering to 5-10 mg\u002Fday 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.",[9],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Babu Lal Meena, DM Hepatology","CONTACT","+91-9781100898","drbabupgi@gmail.com",{"type":37,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100566049","phase-2-induction-of-remission-in-autoimmune-hepatitis-with-azathioprine-vs-mmf-100566049",false,"NCT06650124","Induction of Remission in Autoimmune Hepatitis With Azathioprine vs. MMF","Inclusion Criteria:\n\nDiagnosis: Confirmed diagnosis of autoimmune hepatitis (AIH) based on clinical, biochemical, and histological findings.\n\nBiochemical markers: Elevated liver enzymes, specifically AST and ALT, indicating liver inflammation.\n\nTreatment-naive: Patients must be treatment-naive, meaning they have not received prior immunosuppressive therapy for AIH.\n\nWillingness to participate: Patients must provide informed consent and be willing to comply with all study-related procedures and follow-ups. -\n\nExclusion Criteria:\n\n* Acute liver failure: Patients presenting with acute liver failure at baseline will be excluded.\n\nOther 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.\n\nLow blood counts: Patients with a platelet count less than 50,000\u002Fmm³ or total leukocyte count (TLC) less than 3,000\u002Fmm³ will not be eligible.\n\nPrevious treatment: Patients who have already received immunosuppressive or disease-modifying therapy for AIH or related conditions.\n\nPregnancy or lactation: Pregnant or lactating women will be excluded to avoid potential risks to the mother or fetus.\n\nHepatocellular carcinoma (HCC) or malignancy: Any patients with evidence of hepatocellular carcinoma or other active malignancies.\n\nMedication allergies: Patients with known allergies to azathioprine, mycophenolate mofetil (MMF), or prednisolone will be excluded.\n\nNon-consent: Patients who are not willing to participate in the study or unable to provide informed consent.","ALL","18 Years","65 Years",{"count":48,"type":49},108,"ESTIMATED","INTERVENTIONAL",[52,53],"PHASE2","PHASE3","The goal of this clinical trial is to determine the effectiveness of azathioprine (AZA) versus mycophenolate mofetil (MMF) in inducing remission in treatment-naive patients with autoimmune hepatitis (AIH). The main questions it aims to answer are:\n\nDoes MMF combined with prednisolone lead to higher remission rates compared to AZA with prednisolone after 24 weeks? Is MMF associated with fewer adverse events than AZA in these patients? Researchers will compare two treatment arms (MMF vs. AZA) to see if MMF leads to improved remission rates and safety outcomes.\n\nPrimary Outcome Measure:\n\nBiochemical remission: The primary outcome is the normalization of liver enzymes (AST, ALT) and IgG levels at 24 weeks.\n\nSecondary Outcome Measures:\n\nSafety and adverse events: Monitoring and comparing the incidence and severity of side effects between the two groups.\n\nTreatment adherence: Evaluating how well patients stick to their assigned treatment regimens.\n\nImprovement in quality of life: Assessing changes in the patient's quality of life using validated questionnaires.\n\nReversal of fibrosis: Measured by liver stiffness using Fibroscan, aiming for no progression of fibrosis.\n\nParticipants will:\n\nReceive either MMF or AZA, alongside a tapering dose of prednisolone. Be monitored regularly through clinic visits, laboratory tests, and safety assessments to track remission and any adverse events.",[56],"Autoimmune Hepatitis",[58,59,60,61],"utoimmune Hepatitis (AIH)","Azathioprine (AZA)","Mycophenolate Mofetil (MMF)","Induction of Remission","NOT_YET_RECRUITING","2024-11-05",{"date":65,"type":66},"2024-11-07","ACTUAL",{"date":68,"type":49},"2024-11-01",{"date":70,"type":49},"2025-12-31",{"name":5,"class":6}]