Thrombocytopenia, ImmunePhase 3NCT07455006
Safety and Efficacy Study of QL0911 to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients
A Phase 3 study testing QL0911 in people with Thrombocytopenia, Immune, run by Qilu Pharmaceutical Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Thrombocytopenia, Immune
- What is being tested?
- QL0911
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 10 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of QL0911 in Pediatric Patients With Primary Immune Thrombocytopenia.
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
- Being tested
- QL0911, Placebo
- Keywords
- Immune Thrombocytopenia
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL0911Drug
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.
PlaceboDrug
Matching placebo administered by subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| QL0911 | Experimental | Participants received once weekly subcutaneous QL0911 at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L. Receives: Drug: QL0911 |
| placebo | Placebo comparator | Participants received weekly subcutaneous placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Durable Platelet Response
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.
Measured: Week 18 to week 25
Secondary outcomes (6)
Percentage of Participants With an Overall Platelet Response
Overall platelet response is defined as either a durable platelet response or transient platelet response.
Measured: 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.
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.
Measured: 24 weeks
Number of Weeks With Platelet Response
Number of weeks with platelet counts ≥ 50 x 10^9/L.
Measured: 24 weeks
Percentage of Participants Who Received Rescue Medication During the Treatment Period.
Rescue medication is any medication that is intended to increase platelet counts or prevent bleeding.
Measured: 24 weeks
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Up to Week 38
Number of Participants With Antidrug Antibodies (ADAs) , Anti endogenous TPO antibody and Neutralizing Antibodies (Nab)；
Measured: Up to Week 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start20 Apr 2026 (estimated)
- Primary completion10 Dec 2027 (estimated)
- Study completion10 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombocytopenia, ImmuneStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455006
- Sponsor's protocol ID
- QL0911-303
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of QL0911 in Pediatric Patients With Primary Immune Thrombocytopenia.
- ClinicalTrials.gov ID
- NCT07455006
- Acronym / sponsor ID
- QL0911-303
- Conditions
- Thrombocytopenia, Immune
- Keywords
- Immune Thrombocytopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 10 Dec 2027 (estimated)
- Study completion
- 10 Mar 2028 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL0911 | Experimental | Drug: QL0911Participants received once weekly subcutaneous QL0911 at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L. |
| placebo | Placebo comparator | Drug: PlaceboParticipants received weekly subcutaneous placebo. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QL0911The 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 | QL0911 |
| PlaceboMatching placebo administered by subcutaneous injection. | Drug | placebo |
Primary outcome
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.
6 secondary outcomes
Percentage of Participants With an Overall Platelet Response
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.
Time frame: 24 weeks
Number of Weeks With Platelet Response
Time frame: 24 weeks
Percentage of Participants Who Received Rescue Medication During the Treatment Period.
Time frame: 24 weeks
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Week 38
Number of Participants With Antidrug Antibodies (ADAs) , Anti endogenous TPO antibody and Neutralizing Antibodies (Nab)；
Time frame: Up to Week 38
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QL0911 in people with Thrombocytopenia, Immune, run by Qilu Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Run hui Wu, Doctorate (13370115037, wurunhuigcp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With a Durable Platelet Response (time frame: Week 18 to week 25). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.