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To Observe the Efficacy of Romiplostim N01 in Promoting Platelet Engraftment and Treating Thrombocytopenia After HSCT

Observational Study on Romiplostim N01 for Promoting Platelet Engraftment and Treating Thrombocytopenia After Hematopoietic Stem Cell Transplantation

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113543
Enrollment
Unknown
Registered
2025-12-01
Start date
2025-12-08
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombocytopenia

Interventions

Patients who received romiplostim N01 after HSCT:None
Patients who did not receive romiplostim N01 after HSCT:None

Sponsors

Wuhan Childrens Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or younger; 2. Diagnosed with a hematological disease and undergoing HSCT; 3. Developing post-transplant thrombocytopenia, defined as a platelet count of less than 50×10^9/L lasting for at least one week, or presenting with bleeding symptoms caused by thrombocytopenia; 4. Patient or their legal representative signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Allergy to romiplostim N01 or its excipients; 2. Combined with severe hepatic or renal dysfunction (e.g., transaminase levels exceeding 3 times the upper limit of normal, creatinine clearance less than 30 mL/min); 3. Presence of uncontrolled infectious diseases; 4. Previous splenectomy (as this surgery may affect platelet metabolism and interfere with study results); 5. Expected survival time of less than 3 months (unable to complete full treatment and follow-up).

Design outcomes

Primary

MeasureTime frame
Coagulation function;

Countries

China

Contacts

Public ContactXiong Hao

Wuhan Childrens Hospital

22587481@qq.com+86 27 82433402

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026