Cyclosporine-A Versus Prednisolone for Induction of Remission in Auto-immune Hepatitis

Study Overview
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Brief Summary
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Untreated Autoimmune hepatitis (AIH) is a progressive disease. Mainstay of treatment are corticosteroids (CS). In addition to being ineffective a substantial minority of cases, corticosteroid side-effects hamper effective therapy in another subgroup. Alternative options for induction of remission are limited. There are reports of successful salvage therapy with Cyclosporine-A (CsA) in steroid refractory cases. In addition, open-labeled studies have shown efficacy of Cyclosporine-A in treatment-naive AIH patients. There are no studies comparing CsA and CS in a head to head trial. The investigators aim to assess the efficacy and tolerability of CsA directly to the CS for induction of remission in treatment-naive AIH patients.

Official Title
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Comparing Efficacy and Tolerability of Cyclosporine-A vs. Prednisolone for Induction of Remission in Auto-immune Hepatitis

Conditions
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Autoimmune Hepatitis

Intervention / Treatment
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* Drug: Cyclosporine-A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 16-65 years old individuals with probable of definite AIH according to the revised AIH criteria. Willing and able to participate in the study Exclusion Criteria: Non-consenting patients decompensated cirrhosis, i.e. clinical ascites, hepatic encephalopathy, history of variceal bleeding Presence of serious concomitant cardiovascular, pulmonary or renal condition Presence of active malignant disorder

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group-A<br>Treatment-naive AIH patients consenting to participate | Drug: Cyclosporine-A<br>* Cyclosprorine-A will be administered to patients in group-B according to a set protocol and the patients will be followed at regular intervals with appropriate checking of clinical and para-clinical data.<br>|
| Experimental: Group-B<br>Treatment-naive AIH patients consenting to participate. This group will receive Cyclosporine-A according to a set protocol. | Drug: Cyclosporine-A<br>* Cyclosprorine-A will be administered to patients in group-B according to a set protocol and the patients will be followed at regular intervals with appropriate checking of clinical and para-clinical data.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission | AST/ALT less than 2x UNL No clinical symptom | 12 months | 
| Treatment failure | Failure to achieve AST/ALT less than 2x UNL despite adjusting dose according to protocol | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of adverse events | Any adverse event (related or unrelated to the study drug) occuring during the induction phase. | 12 months | 
| Serious adverse event | Any adverse event requiring hospitalization or leading to disability or death | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autoimmune hepatitis, corticosteroids, cysclosporine-A, treatment, treatment-naive, induction of remossion, efficacy, tolerability