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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group-A | Active Comparator | Treatment-naive AIH patients consenting to participate |
|
| Group-B | Experimental | Treatment-naive AIH patients consenting to participate. This group will receive Cyclosporine-A according to a set protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine-A | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Disease Research Center, Shariati Hospital | Tehran | 14117 | Iran |
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| ID | Term |
|---|---|
| D019693 | Hepatitis, Autoimmune |
| ID | Term |
|---|---|
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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| 12 months |
| D001327 |
| Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |