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A randomized controlled open-label clinical trial of ursodeoxycholic acid combined with low dose glucocorticoid in the treatment of PBC With AIH Features II to asses efficacy and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ursodeoxycholic Acid group | Active Comparator | Ursodeoxycholic Acid 13-15mg/kg/d |
|
| Ursodeoxycholic Acid+Low Dose Glucocorticoid group | Experimental | Ursodeoxycholic Acid 13-15mg/kg/d+Methylprednisolone 12mg/d in induction period and 2-4mg/d in maintenance period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ursodeoxycholic acid | Drug | Participants received Ursodeoxycholic acid (13-15mg/kg/d po.) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical remission | The percentage of patients in biochemical remission, defined as normalization of serum ALT and IgG levels after treatment, per treatment group. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Partial remission | Partial remission, defined as ALT or AST serum levels >1x Upper Limit of Normal (ULN) and <2x ULN | up to 12 months |
| Minimal response | Minimal response, defined as decrease of ALT or AST serum levels but still >2x ULN |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
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| Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone) | Drug | Participants received Methylprednisolone (12mg/d po. in induction and 2-4mg/d in maintenance) combined with Ursodeoxycholic acid (13-15mg/kg/d po.) |
|
|
| up to 12 months |
| Treatment failure | defined as no improvement or increase of ALT or AST serum levels | up to 12 months |
| ALT,AST,IgG | serum ALT,AST and IgG levels | baseline and month 3,6,12 |
| percentage of immune cells | percentage of T cells, cDC, MDSC, Treg, Breg, plasma cells, NK, NKT | baseline and month 12 |
| Side-effects | Drug related side-effects | up to 12 months |
| ID | Term |
|---|---|
| D019693 | Hepatitis, Autoimmune |
| D008105 | Liver Cirrhosis, Biliary |
| ID | Term |
|---|---|
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002780 | Cholestasis, Intrahepatic |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014580 | Ursodeoxycholic Acid |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |
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