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NCT Number: NCT07455006

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

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.

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Key information

Conditions

Thrombocytopenia, Immune Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2;
  • Patients of child-bearing potential must agree to use effective contraception during the study and for 3 months following the last dose of study treatment.

Exclusion criteria

  • 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;
  • Had received antibody-based therapies within 14 weeks before the first dose.
  • Patients with concurrent or past malignant disease.
  • Serum creatinine or total bilirubin >1.5*ULN) alanine transaminase (ALT) or aspartate transaminase (AST) >3* ULN.
  • Had received antibody-based therapies within 14 weeks before the first dose.
  • Had prothrombin time (PT) or prothrombin time-international normalized ratio (PT-INR) or activated partial thromboplastin time (APTT) exceeded 20% of the reference range of normal values.

Treatment and study plan

QL0911

Drug

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.

Placebo

Drug

Matching placebo administered by subcutaneous injection.

Primary outcomes

  1. Percentage of Participants With a Durable Platelet Response

    Time frame: Week 18 to week 25

    A participant with durable platelet response was defined as achieving at least 6 weekly platelet counts of ≥ 50 x 10^9/L from week 18 to week 25. If a platelet count from a participant was not available (missing) in a certain week, that week was imputed as non-response for that participant. Platelet counts were not deemed as a positive response for 4 weeks after the administration of rescue medication.

Secondary outcomes

  1. Percentage of Participants With an Overall Platelet Response

    Time frame: 24 weeks

    Overall platelet response is defined as either a durable platelet response or transient platelet response.

  2. The proportion of subjects with a weekly platelet count ≥ 30 × 10^9/Land at least twice the baseline platelet count without bleeding during the double-blind period of 24 weeks.

    Time frame: 24 weeks

    The proportion of subjects with a weekly platelet count ≥ 30 × 10^9/Land at least twice the baseline platelet count without bleeding during the double-blind period of 24 weeks.

  3. Number of Weeks With Platelet Response

    Time frame: 24 weeks

    Number of weeks with platelet counts ≥ 50 x 10^9/L.

  4. Percentage of Participants Who Received Rescue Medication During the Treatment Period.

    Time frame: 24 weeks

    Rescue medication is any medication that is intended to increase platelet counts or prevent bleeding.

  5. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to Week 38

  6. Number of Participants With Antidrug Antibodies (ADAs) , Anti endogenous TPO antibody and Neutralizing Antibodies (Nab)；

    Time frame: Up to Week 38

Study contacts

Contact information is provided by the study sponsor or research team.

Run hui Wu, Doctorate

CONTACT

[email protected]

13370115037

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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