Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by mycophenolate mofetil versus cyclosporin A
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclosporin A | Experimental |
| |
| Mycophenolate Mofetil | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporin A | Drug | Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with cyclosporin A) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical remission | The percentage of patients in biochemical remission, defined as normalization of serum ALT and IgG levels after 24 weeks of treatment, per treatment group. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Partial remission | Partial remission, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) serum levels >1x Upper Limit of Normal (ULN) and <2x ULN | up to 6 months |
| Minimal response |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoli Fan, Master degree | Contact | +86 13980433451 | 13980433451@163.com | |
| Li Yang | Contact | +86 13518178110 | yangli_hx@scu.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WestChina Hospital | Recruiting | Chengdu | Sichuan | 610041 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Mycophenolate Mofetil | Drug | Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with mycophenolate mofetil ) |
|
Minimal response, defined as decrease of ALT or AST serum levels but still >2x ULN
| up to 6 months |
| Treatment failure | defined as no improvement or increase of ALT or AST serum levels | up to 6 months |
| Changes in liver stiffness | liver stiffness will be measured by shear-wave elastography | up to 6 months |
| Side-effects | Drug related side-effects | up to 6 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
Not provided
Not provided