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| Name | Class |
|---|---|
| Beijing Trendful Kangjian Medical Information Consulting Limited Company | OTHER |
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Though ursodeoxycholate acid (UDCA) is the wellknown effective therapy for PBC, clinical effectiveness of UDCA may be limited by its poor absorption and extensive biotransformation. The more hydrophilic bile acid tauroursodeoxycholate (TUDCA) is the active ingredients of UDCA, and has been approved by state food and drug administration in China for treatment of cholesterol stones. So it is necessary to verify the efficacy and safety of TUDCA in the treatment of adult primary biliary cirrhosis. In this randomized, double-blinded, double-dummy, parallel-controlled and multicenter clinical trial, we detect the proportion of patients who had AKP decline more than 25% as the primary outcome; decline of AKP, total bilirubin, GGT, ALT and AST as secondary outcomes after patients were treated with TUDCA or UDCA for 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Tauroursodeoxycholic Acid Capsules,250mg,tid. |
|
| Group 2 | Active Comparator | Ursodeoxycholate acid capsules, 250mg,tid, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tauroursodeoxycholic Acid Capsules | Drug | 250mg.tid.po |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients who had AKP decline more than 25% after 24 weeks treatment of UDCA | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| ALP decline from baseline after 24 weeks treatment of TUDCA | 12 month | |
| Total bilirubin decline from baseline after 24 weeks treatment of TUDCA | 12 months | |
| GGT decline from baseline after 24 weeks treatment of TUDCA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dong Ji Jia, Doctor | Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing 302 Hospital | Beijing | Beijing Municipality | China | |||
| Beijing Ditan Hospital |
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| Ursodeoxycholic Acid Capsules | Drug | 250mg.tid.po |
|
|
| 12 months |
| ALT and AST decline from baseline after 24 weeks treatment of TUDCA | 12 months |
| Beijing |
| Beijing Municipality |
| China |
| Beijing Friendship Hospital | Beijing | Beijing Municipality | China |
| Beijing Youan Hospital | Beijing | Beijing Municipality | China |
| Chinese PLA General Hospital | Beijing | Beijing Municipality | China |
| Peiking University First Hosptial | Beijing | Beijing Municipality | China |
| Peking University People's Hospital | Beijing | Beijing Municipality | China |
| First Affiliated Hospital,SunYat-Sen University | Guangzhou | Guangdong | China |
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | China |
| Third Affiliated Hospital,SunYat-Sen University | Guangzhou | Guangdong | China |
| Tongji Hospital | Wuhan | Hunan | China |
| 85 Military Hospital | Shanghai | Shanghai Municipality | China |
| Eastern Hepatobiliary Surgery Hospital | Shanghai | Shanghai Municipality | China |
| Huashan Hospital | Shanghai | Shanghai Municipality | China |
| NO.3 People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | China |
| RenJi Hospital | Shanghai | Shanghai Municipality | China |
| RuiJin Hospital | Shanghai | Shanghai Municipality | China |
| ShangHai Changzheng Hospital | Shanghai | Shanghai Municipality | China |
| Shanghai Public Health Clinical Center | Shanghai | Shanghai Municipality | China |
| Shanghai Zhongshan Hospital | Shanghai | Shanghai Municipality | China |
| Xijing Hospital | Xian | Shanxi | China |
| West China Hospital | Chengdu | Sichuan | China |
| First Affiliated Hospital Of KunMing Medical College | Kunming | Yunnan | China |
| The Sixth People's Hospital of Hangzhou | Hangzhou | Zhejiang | China |
| First Affiliated Hospital of Zhejiang University | Zhejiang | Zhejiang | 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 |
|---|---|
| C031655 | ursodoxicoltaurine |
| 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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