A Randomized,Open-label Dose-discovery Study of PEG-rhG-CSF and rhG-CSF Used for Aplastic Anemia Granulocyte Deficiency

• Status: Recruiting
• Trial end date: 2026-01-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital

Criteria

Inclusion Criteria:Subjects eligible for inclusion in this study must meet all of the following criteria: 1.Age 18-70 years old, male or female, or weight≥50kg.2.Patients with severe or very severe aplastic anemia of absolute neutrophil value< 0.5×109/L 3. ECOG score ≤ 2 points. 4. Normal renal function.

Exclusion Criteria:Subjects meeting any of the following criteria were excluded from this study: 1. Patients with clonal chromosomal abnormalities.2.Patients with previous malignant tumors. 3.Patients with severe or uncontrolled infectious diseases and /or bleeding. 4. Patients with AIDS or syphilis positive. 5. Severe organ dysfunction. 6. Patients used GM/G-CSF,PEG-rhG-CSF,interleukin-11 within 2 weeks before admission.7. Allergic to G-CSF or PEG-rhG-CSF related components. 8. Participated in other clinical trials within 6 months.