About This Clinical Trial
Primary immune thrombocytopenia (ITP) is one of the most common acquired bleeding disorders in children. Chronically low platelet counts not only restrict daily activities but also place tremendous psychological burden on the entire family.
To help more children with ITP, Jingdu Children's Hospital is participating in a multi-center, randomized, double-blind, placebo-controlled Phase III clinical trial evaluating Romiplostim N01 (QL0911) — a novel thrombopoietin receptor agonist developed by Qilu Pharmaceutical Co., Ltd.
Romiplostim N01 is a thrombopoietin (TPO) receptor agonist. By binding to the TPO receptor, it stimulates the growth of megakaryocytes in the bone marrow, thereby increasing platelet production and treating thrombocytopenia.
Trial Overview
This study has been approved by the National Medical Products Administration (NMPA) and the Ethics Committee of Jingdu Children's Hospital. Approximately 20 hospitals nationwide are participating, with a target enrollment of ~60 pediatric patients with ITP across China.
Who Can Participate?
✓ Inclusion Criteria
- Age 1 to <18 years at the time of informed consent
- Clinical diagnosis of primary ITP for at least 12 months prior to randomization (per the 2021 Chinese Guidelines for Diagnosis and Treatment of Primary ITP in Children)
- Prior first-line ITP treatment that was ineffective or resulted in relapse
- Average platelet count <30×10⁹/L (from 2 measurements taken ≥24 hours apart during screening), with neither count exceeding 35×10⁹/L
- ECOG performance status score of 0–2
- Parent or guardian willing to provide written informed consent; patients ≥8 years are also encouraged to provide written assent
✕ Key Exclusion Criteria
- History of bone marrow stem cell abnormalities, or bone marrow changes other than those typical of ITP
- Known congenital thrombocytopenia or secondary thrombocytopenia due to autoimmune disease
- Splenectomy within 12 weeks before first dose
- Known failure to respond to any TPO receptor agonist (romiplostim, rhTPO, eltrombopag, hetrombopag, avatrombopag, etc.)
- ITP drug treatment (including rescue therapy) within 2 weeks before first dose
- Use of Nplate® (romiplostim), Revolade® (eltrombopag), rHuTPO, or other c-Mpl–stimulating agents within 4 weeks before first dose
How to Register
If your child may qualify, please contact the study coordinator at Jingdu Children's Hospital directly:
📞 Contact the Study Team
Our clinical research team is happy to answer your questions and assess eligibility in confidence.
A Note from the Hospital
Primary immune thrombocytopenia is one of the most common acquired bleeding disorders in children. Long-term low platelet counts not only affect a child's daily activities but also place enormous psychological pressure on the whole family.
If your child has been struggling with recurrent ITP flare-ups, please consider reaching out. One phone call could open another door. All personal information will be kept strictly confidential in accordance with applicable regulations. Your participation contributes to the advancement of pediatric medicine and helps future children with ITP.