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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-17
SponsorQilu Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 1 years old and < 18 years old.

Diagnosed primary ITP for at least 12 months;

Had received at least one first-line ITP treatment with no response or recurrence after treatment;

Had a platelet count <30×10^9/L within 48 hours before the first dose;

Disqualifiers

Had a history of bone marrow stem cell abnormalities or myelodysplastic syndrome other than ITP-specific changes.

Underwent splenectomy within 12 weeks before the first dose;

Had received ITP treatments (including rescue treatment) within 2 weeks before the first dose;

Had received romiplostim (Nplate®) or eltrombopag (Revolade®), rhTPO or other agents that stimulate TPO receptors (also known as c-Mpl)within 4 weeks before the first dose;

Trial design

Treatments tested in this trial

  • QL0911
  • Placebo

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators