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This is an evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety of multicenter, randomized, open label clinical trial.
evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ademetionine 1 | Experimental | Ademetionine 2000mg |
|
| Ademetionine 2 | Experimental | Ademetionine 1000mg |
|
| Ademetionine 3 | Active Comparator | no treatment in first 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ademetionine 2 | Drug | Ademetionine 1000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 500mg po bid with general antiviral treatment for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| levels of serum total bilirubin declined from baseline | levels of serum total bilirubin declined from baseline | 2 weeks |
| Alkaline Phosphatase | Alkaline Phosphatase | 10 weeks |
| Gamma-Glutamyl Transpeptidase | Gamma-Glutamyl Transpeptidase | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| level of serum direct bilirubin decline from baseline | level of serum direct bilirubin decline from baseline | 2 weeks, 6 weeks, 10 weeks |
| level of serum bile acids decline from baseline | level of serum bile acids decline from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Chen | Contact | 00862137990333 | chenlian@shaphl.org |
| Name | Affiliation | Role |
|---|---|---|
| Liang Chen | Public Health Clinical Center Affiliated to Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public Health Clinical Center Affiliated to Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D002779 | Cholestasis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| Ademetionine 1 | Drug | Ademetionine 2000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks |
|
| Ademetionine 3 | Drug | no treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks |
|
| 2 weeks, 6 weeks, 10 weeks |
| glutamic pyruvic transaminase | glutamic pyruvic transaminase | 2 weeks, 6 weeks, 10 weeks |
| glutamic oxaloacetic transaminase | glutamic oxaloacetic transaminase | 2 weeks, 6 weeks, 10 weeks |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |