Skip to content

A Prospective Multicenter Randomized Controlled Clinical Study on the Efficacy and Safety ofRomiplostim (N01) in the Prevention ofThrombocytopenia after Chemotherapy for Childhood Tumors

A Prospective Multicenter Randomized Controlled Clinical Study on the Efficacy and Safety ofRomiplostim (N01) in the Prevention ofThrombocytopenia after Chemotherapy for Childhood Tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114006
Enrollment
Unknown
Registered
2025-12-05
Start date
2025-12-20
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 following chemotherapy in paediatric oncology

Interventions

Romiplostim (N01) intervention group:Administration of Ropastin N01

Sponsors

The First Affiliated Hospital,Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1.0 years old = 1.5×10^9 /L, PLT >= 80×10^9 /L, Hb >= 75g/L, WBC >= 3.0×10^9 /L); 7. Receiving high intensity chemotherapy regimens such as SCCCG lymphoma regimen, CAV/IE, VIP regimen, etc., with an expected degree II or greater myelosuppression after chemotherapy. 8. The legal guardian of the subject must sign the informed consent form. Translated with DeepL.com (free version)

Exclusion criteria

Exclusion criteria: 1.Poorly controlled systemic infection. 2.Severe dysfunction of vital organs. 3.Participation in any clinical trial involving Nplate (Romiplostim) N01 or similar pharmaceuticals within 4 weeks prior to enrollment. 4.Known hypersensitivity to Nplate (Romiplostim) N01. 5.Severe psychiatric disorder that may compromise the provision of informed consent and/or the reporting or observation of adverse reactions. 6.Patients deemed by the investigator to be otherwise unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
The proportion of patients with platelet count<50 × 10 ^9 /L during the prophylactic treatment period of Lopsetin N01;

Secondary

MeasureTime frame
PLT < 50 × 10 ^9 /L duration;The proportion and corresponding number of platelet transfusions received;incidence of treatment-related adverse reactions;

Countries

China

Contacts

Public ContactYan-Lai Tang

The First Affiliated Hospital,Sun Yat-sen University

tangylai@mail.sysu.edu.cn+86 15626202579

Outcome results

None listed

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