NCT07455006

Safety and Efficacy Study of QL0911 to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of QL0911 in Pediatric Patients With Primary Immune Thrombocytopenia.

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate efficacy and of safety QL0911 in the treatment of thrombocytopenia in pediatric patients with previously treated chronic ITP.

Conditions

• Thrombocytopenia, Immune

Interventions

Type	Name	Description
DRUG	QL0911	The starting dose of QL0911 is 1 µg/kg administered weekly by subcutaneous injection. Participants will return to the clinic weekly to provide platelet counts and undergo dose titrations under the supervision of the treating physician. Weekly dose increases will continue in increments of 1 µg/kg up to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10\^9/L. Dose adjustment will be allowed during the treatment period to maintain a platelet count between ≥ 50 x 10\^9/L and ≤ 200 x 10\^9/L.
DRUG	Placebo	Matching placebo administered by subcutaneous injection.

Timeline

• Start date: 2026-04-20
• Primary completion: 2027-12-10
• Completion: 2028-03-10
• First posted: 2026-03-06
• Last updated: 2026-03-06