Efficacy and Safety of QL0911 in Adult Patients With Chronic Primary Immune Thrombocytopenia: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Trial

• Status: Completed
• Trial end date: 2021-12-16
• Target enrollment: 0
• Participant gender: All

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 adults' patients with primary chronic ITP during a 24-week treatment period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• Aged ≥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;

• Fully understand and comply with the requirements of this study, and voluntarily sign the informed consent form.

Exclusion Criteria:

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

• Had arterial thrombosis, or venous thromboembolism; severe cardiovascular diseases; malignant tumors; secondary thrombocytopenia caused by autoimmune diseases.

• 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), and hematopoietic growth factors (HGFs) within 4 weeks before the first dose;

• 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;

• 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;

• 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.