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About 1/3 of patients with primary biliary cholangitis (PBC) exhibit moderate to severe interface hepatitis, and this group of patients have poor response to UDCA treatment. However, as it is not yet sufficient to diagnose autoimmune hepatitis or overlap syndrome, it is difficult to initiate immunosuppressive therapy such as steroids according to current guidelines. The aim of this study is to explore whether PBC patients with moderate to severe interfacial inflammation can benefit from UDCA combined with prednisone therapy, and its treatment safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone | Experimental | Combination therapy of UDCA (13-15 mg/kg/day) and prednisone. Prednisone 30-40 mg/day, at 7am in the morning, gradually reduced after 1 month (5mg every 7-14 days) to 5-10 mg for maintenance treatment | |
| UDCA | Active Comparator | UDCA (13-15 mg/kg/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug | Prednisone 30-40 mg/day, at 7am in the morning, gradually reduced after 1 month (5mg every 7-14 days) to 5-10 mg for maintenance treatment | ||
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with biochemical response | Alkaline Phosphatase < 1.67*ULN | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the pruritus and fatigue | Change From Baseline in Fatigue and Pruritus as Assessed by Visual Analogue Scale (VAS) Total Score for Fatigue and Pruritus. (0-10, higher scires mean a worse outcome) | 1, 3, 6, 9, and 12 months |
| Survival without transplantation and hepatic impairment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital | Guangzhou | Guangdong | China | |||
| Xijing hospital |
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| UDCA (Ursodeoxycholic acid) |
| Drug |
13-15 mg/kg/day |
|
Occurrence of ascites, variceal bleeding, hepatic encephalopathy, liver-transplantation, or death. |
| 1 year |
| Xi'an |
| Shaanxi |
| 710032 |
| China |
| ID | Term |
|---|---|
| D008105 | Liver Cirrhosis, Biliary |
| ID | Term |
|---|---|
| D002780 | Cholestasis, Intrahepatic |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| D014580 | Ursodeoxycholic Acid |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D002757 | Cholanes |
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