A Post-marketing Surveillance Study Evaluating the Safety and Tolerability of the Labeled Use of Hetero-Darbepoetin Alfa in Indian Patients

Hetero Drugs Limited0 个研究点目标入组 503 人开始时间: 待定最近更新: 2023年12月19日

试验速览

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•1. Male and female adult patients.
•2. Patients need to be administered Hetero-Darbepoetin alfa in order to be enrolled in the surveillance.
•3. Patients of (CKD) suffering from renal anemia.
•4. Treatment of anemia due to the effect of concomitantly administered chemotherapy in patients that have shown a reduction in the need for RBC transfusions in patients with metastatic, non-myeloid malignancies.
•5. Any other patient to be prescribed Hetero-Darbepoetin alfa as per prescribing physician’s discretion as per prescribing information.

•1. Patients not administered/ contraindicated Hetero-Darbepoetin alfa.
•2. Patients who are likely to be pregnant or lactating patients.
•3. Patients with clinical history/ evidence of allergy/ hypersensitivity to components of Hetero-Darbepoetin alfa.
•4. Patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy
•5. Patients receiving myelosuppressive therapy when the anticipated outcome is cure

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