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An open-label,pilot study to evaluate the efficacy and safety of plasma exchange combination of immunosuppressive regimens, for the remission of autoimmune hepatitis (AIH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plasma exchange combination of immunosuppressive regimens | Experimental | Plasma exchange(once) ,with the following standard immunosuppressive regimens for the remission of auto-immune hepatitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma exchange combination of immunosuppressive regimens | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of patients that achieve biochemical remission of AIH | Month 6 after the treatment initiated |
| Measure | Description | Time Frame |
|---|---|---|
| Alanine transaminase (ALT) | Day 1, and Week 1, 2, 4, 12, 24 | |
| Aspartate transaminase(AST) | Day 1, and Week 1, 2, 4, 12, 24 | |
| Globin(GLB) |
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Inclusion Criteria:
Exclusion Criteria:
The presence of hepatitis A, B, C, D, or E virus infection;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoli Fan, MM | Contact | +862885422311 |
| Name | Affiliation | Role |
|---|---|---|
| Li Yang, MD | West China Hospital,Chengdu, Sichuan, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital | Recruiting | Chengdu | Sichuan | 610041 | China |
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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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| Day 1, and Week 1, 2, 4, 12, 24 |
| Immunoglobulin G(IgG) | Day 1, and Week 1, 2, 4, 12, 24 |
| Total bilirubin(TB) | Day 1, and Week 1, 2, 4, 12, 24 |
| Direct bilirubin(DB) | Day 1, and Week 1, 2, 4, 12, 24 |
| D001327 |
| Autoimmune Diseases |
| D007154 | Immune System Diseases |