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This study evaluates the effect of 18-22mg/kg/d Ursodeoxycholic in refractory Primary Biliary Cholangitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18-22mg/kg/d Ursodeoxycholic group | Experimental |
| |
| 13-15mg/kg/d Ursodeoxycholic group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18-22mg/kg/d Ursodeoxycholic | Drug | 18-22mg/kg/d Ursodeoxycholic |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC) | Percent of patients that achieve biochemical remission of primary biliary cholangitis(PBC) in two arms. | Month 6 during treatment with 13-15mg/kg/d ursodeoxycholic acid or 18-22mg/kg/d ursodeoxycholic acid |
| Measure | Description | Time Frame |
|---|---|---|
| Alkaline phosphatase | (ALP) | Week 2 and Month 1, 3, 6,9,12 |
| Glutamyltransferase | (GGT) | Week 2 and Month 1, 3, 6,9,12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ping Ni, MD | Contact | 13281091993 | 545043216@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Yang, MD | West China Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital | Recruiting | Chengdu | Sichuan | 610041 | China |
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| ID | Term |
|---|---|
| D008105 | Liver Cirrhosis, Biliary |
| ID | Term |
|---|---|
| D002780 | Cholestasis, Intrahepatic |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
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| 13-15mg/kg/d Ursodeoxycholic |
| Drug |
13-15mg/kg/d Ursodeoxycholic |
|
| Alanine transaminase | (ALT) | Week 2 and Month 1, 3, 6 |
| Aspartate transaminase | (AST) | Week 2 and Month 1, 3, 6, 9,12 |
| Total bilirubin | (TB) | Week 2 and Month 1, 3, 6, 9,12 |
| D004066 |
| Digestive System Diseases |
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |