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This prospective, single-center, observational cohort study aims to systematically observe and describe the clinical characteristics of adverse reactions in patients with aplastic anemia undergoing ATG (Anti-Thymocyte Globulin) /ALG (Anti-Lymphocyte Globulin) treatment, providing a data foundation for the development of relevant management strategies. This study plans to enroll 200 aplastic anemia patients undergoing ATG/ALG treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with aplastic anemia undergoing ATG or ALG treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATG/ALG | Drug | Participants will receive ATG/ALG according to standard dosing protocols as per clinical guidelines. During treatment, we will monitor and document any adverse reactions, including their type, severity, duration, and any necessary interventions or changes in treatment plan. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with serum sickness and its severity | Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess its severity | Within 4 weeks after ATG/ALG infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with liver and kidney function damage and its severity | Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess its severity | During ATG/ALG infusion (typically from d1 to d6) and within 4 weeks after ATG/ALG infusion |
| Percentage of patients with infusion reaction and its severity |
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Inclusion Criteria:
Exclusion Criteria:
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Aplastic anemia patients treated with ATG/ALG
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weiwang Li, PhD | Contact | 15332132036 | liweiwang@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regenerative Medicine Center and Red Blood Cell Disorders Center | Recruiting | Tianjin | China |
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| ID | Term |
|---|---|
| D000741 | Anemia, Aplastic |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000080983 | Bone Marrow Failure Disorders |
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|
Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess its severity |
| During ATG/ALG infusion(typically from d1 to d6) |
| D001855 | Bone Marrow Diseases |