Efficacy and Safety of QL0911 in Adult Patients With Chronic Primary Immune Thrombocytopenia
Study Details
Study Description
Brief Summary
QL0911, a recombinant human thrombopoietin mimetic peptide-Fc fusion protein for injection, is a romiplostim (Nplate®) biosimilar for the treatment of primary immune thrombocytopenia (ITP). This phase III study aimed to assess the efficacy and safety of QL0911 in adult patients with primary chronic ITP.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This study consisted of a randomized, double-blind, placebo-controlled, 26-week treatment period, sequentially followed by an open-label, single-arm, 12-week treatment period, and an additional 4-week safety follow-up period.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: QL0911
|
Drug: QL0911
The study in a 2:1 randomization ratio(144 subjects to QL0911). Qilu investigational product (QL0911 or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.
|
| Placebo Comparator: Placebo
|
Drug: Placebo comparator
The study in a 2:1 randomization ratio(72 subjects to Placebo ). Qilu investigational product (QL0911 or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.
|
Outcome Measures
Primary Outcome Measures
- proportion of patients achieving durable platelet response at week 24 during the double-blind treatment period [24weeks]
Secondary Outcome Measures
- proportion of patients with weekly platelet responses within 24 weeks of treatment; [24weeks]
- Proportion of patients who achieved platelet count ≥ 30 × 10^9/L at least a two-fold increase from baseline platelet count without bleeding during the 24-week double-blind period; [24weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Aged ≥18 years old;
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Diagnosed primary ITP for at least 12 months;
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Had received at least one first-line ITP treatment with no response or recurrence after treatment;
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Had a platelet count <30×10^9/L within 48 hours before the first dose;
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Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2;
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Fully understand and comply with the requirements of this study, and voluntarily sign the informed consent form.
Exclusion Criteria:
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Had a history of bone marrow stem cell abnormalities or myelodysplastic syndrome other than ITP-specific changes.
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Had arterial thrombosis, or venous thromboembolism; severe cardiovascular diseases; malignant tumors; secondary thrombocytopenia caused by autoimmune diseases.
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Underwent splenectomy within 12 weeks before the first dose;
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Had received ITP treatments (including rescue treatment) within 2 weeks before the first dose;
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Had received romiplostim (Nplate®) or eltrombopag (Revolade®), rhTPO or other agents that stimulate TPO receptors (also known as c-Mpl), and hematopoietic growth factors (HGFs) within 4 weeks before the first dose;
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Had received antineoplastic agents within 8 weeks before the first administration, but when treating ITP with hypomethylating agents (HMA) such as decitabine, a 4-week washout period was acceptable, as judged by the investigator;
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Had received antibody-based therapies within 14 weeks before the first dose; 8) had serum creatinine or total bilirubin >1.5 upper limit of normal (ULN), alanine transaminase (ALT) or aspartate transaminase (AST) >3 ULN, hemoglobin < 100g/L, absolute neutrophil count <1.5x10^9/L;
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Qilu Hospital of Shandong University | Shandong | China |
Sponsors and Collaborators
- Qilu Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- QL0911-003