A Randomized,Open-label Dose-discovery Study of PEG-rhG-CSF and rhG-CSF in the Adjuvant Therapy of Aplastic Anemia Granulocyte Deficiency
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study was a single-center,open-label,randomized,dose-exploring prospective study.Patients with granulocytotic aplastic anemia who received cytokine treatment with PEG-rhG-CSF or rhG-CSF were enrolled.Clinical demographic data,disease characteristics of aplastic anemia,clinical diagnosis and treatment,laboratory data and adverse events were collected to explore the dose and safety of PEG-rhG-CSF and rhG-CSF in patients with severe aplastic anemia.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Age 18-70 years old, male or female, or weight≥50kg.
• Patients with severe or very severe aplastic anemia of absolute neutrophil value\< 0.5×109/L
• ECOG score ≤ 2 points.
• Normal renal function.
Locations
Other Locations
China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Contact Information
Primary
Fengkui Zhang, Doctor
fkzhang@ihcams.ac.cn
+862223909229
Backup
Huihui Fan, Doctor
fanhuihui@ihcams.ac.cn
+862223909223
Time Frame
Start Date: 2022-06-05
Estimated Completion Date: 2026-01-05
Participants
Target number of participants: 45
Treatments
Experimental: PEG-rhG-CSF group A
PEG-rhG-CSF group A(q7d):6mg d1,8,subcutaneously injected,after monitoring ANC\>0.5×109/L,the drug was stopped,and then ANC\<0.5×109/L was temporarily supplemented with one dose of the same drug.
Experimental: PEG-rhG-CSF group B
PEG-rhG-CSF group B(q10d):6mg d1,11,subcutaneously injected,after monitoring ANC\>0.5×109/L,the drug was stopped,and then ANC\<0.5×109/L was temporarily supplemented with one dose of the same drug.
Experimental: rhG-CSF group(short-acting )
rhG-CSF group(short-acting ): 480ug d1-14(daily for 14days),subcutaneously injected.After monitoring ANC\>0.5×109/L,the drug was stopped,and then ANC\<0.5×109/L was temporarily supplemented with one dose of the same drug.
Related Therapeutic Areas
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China