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To compare the safety and efficacy of 12 months of low dose prednisone with low dose cyclosporine combined with entecavir in patients with thrombocytopenia associated with HBV-related cirrhosis.
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| Measure | Description | Time Frame |
|---|---|---|
| treatment failure | The primary efficacy outcome was treatment failure, defined as the composite of (1) any platelet count below 50×109/L after four weeks treatment; (2) significant bleeding, defined as grade 2 severity from any anatomical site as per the ITP bleeding scale that defines bleed grades (0, none; 1, mild; or 2, marked) by objective criteria of 9, based on events that occurred since the last study visit; or (3) rescue treatment administered because of severe thrombocytopenia, bleeding, or a planned invasive procedure. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients with a complete platelet count response | Secondary end points included proportion of patients with a complete platelet count response (platelet count of ≥ 100×109/L) without rescue treatment at 4 weeks, at 6 months , and at 12 months | at 4 weeks, at 6 months , and at 12 months |
| proportion of patients with an overall platelet count response |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients were enrolled from 15 centers in China from January 1, 2005 to September 31, 2013.
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 6, 2014 | |
| Reset | Jul 9, 2014 | |
| Release | Apr 17, 2016 | |
| Reset | May 24, 2016 | |
| Release | Sep 14, 2016 | |
| Unrelease | Yes |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 6, 2014 | Jul 9, 2014 | |||
| Apr 17, 2016 |
| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| D006509 | Hepatitis B |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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whole blood
Secondary end points included proportion of patients with an overall platelet count response (platelet count of ≥ 30×109/L with doubling from baseline) without rescue treatment at 4 weeks, at 6 months , and at 12 months |
| at 4 weeks, at 6 months , and at 12 months |
| May 24, 2016 |
| Sep 14, 2016 | Yes |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |