drugset / Trial / NCT04500886
Evaluate the Efficacy and Safety of PEG-rhG-CSF in Patients With Hemophagocytic Syndrome
Unknown
50 enrolled
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Beijing Friendship Hospital · collab
Non-randomizedParallel-groupOpen-labelPrevention
Summary
Hemophagocytic syndrome (HPS), also known as hemophagocytic lymphohistiocytosis (HLH), is an immune mediated life-threatening disease. There is no uniform recommendation for salvage treatment of HLH. Based on the results of current clinical trials, the marketing situation of the drug in China, and the use requirements of pegylated recombinant human granulocyte stimulating factor(PEG-rhG-CSF), this study was conducted in patients who received the DEP rescue therapy or dexamethasone combined with VP-16 maintenance therapy. The aim of this study was to evaluate the efficacy and safety of PEG-rhG-CSF(Jinyouli®) for the recovery of neutropenia after chemotherapy in patients with hemophagocytic syndrome.
Timeline
- Start
- 2020-08-01
- Primary completion
- 2021-08-01
- Completion
- 2022-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pegfilgrastim | Protein / enzyme biologic | 3 mg | Subcutaneous |
| Subject | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |
| Comparator | filgrastim | Protein / enzyme biologic | 150 ug | Subcutaneous |
| Comparator | filgrastim | Protein / enzyme biologic | 300 ug | Subcutaneous |