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Current standard therapy of primary biliary cholangitis-autoimmune hepatitis overlap syndrome(PBC-AIH overlap) consists of a combination of prednisolone and azathioprine. However, a significant proportion of patients may do not respond to, or is intolerant for azathioprine. Several studies have documented the efficacy and safety of mycophenolate mofetil(MMF) as second-line therapy for PBC-AIH overlap. However, robust evidence from a formal randomized clinical trial for the first-line immunosuppressor is in need.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone and Mycophenolate mofetil | Experimental |
| |
| Methylprednisolone and Azathioprine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone and Mycophenolate mofetil | Drug | Methylprednisolone combination of mycophenolate mofetil |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical remission | The percentage of patients in remission, defined as normalization of serum transaminase and IgG levels after 6 months of treatment, per treatment group | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The level of IgG value in both groups | at 1 month | |
| The level of IgG value in both groups | at 3-month | |
| The level of IgG value in both groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoli Fan, Master degree | Contact | +86 13980433451 | 13980433451@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan Univerisity | Recruiting | Chengdu | Sichuan | 610041 | China |
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| Methylprednisolone and azathioprine | Drug | Methylprednisolone combination of azathioprine |
|
| at 6-month |
| Adverse drug reactions | 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 |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D009173 | Mycophenolic Acid |
| D001379 | Azathioprine |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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