Efficacy and Safety of QL0911 in Adult Patients With Chronic Primary Immune Thrombocytopenia

NCT ID: NCT05621330

Last Updated: 2022-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-18
• Study Completion Date: 2021-12-16

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.

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.

Conditions

Primary Immune Thrombocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

QL0911

Group Type: EXPERIMENTAL

QL0911

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Placebo comparator

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Qilu Hospital of Shandong University

Shandong, , China

Countries

China

References

Zhou H, Han S, Jin J, Huang R, Guo X, Shen X, Wang B, Wang X, Yao H, Du X, Huang M, Ran X, Wang W, Yang T, Zhang F, Zheng C, Zuo X, Fu R, Gao D, Ge Z, Han Y, Li Y, Kang X, Shi Y, Hou M. Efficacy and safety of QL0911 in adult patients with chronic primary immune thrombocytopenia: A multicenter, randomized, double-blind, placebo-controlled, phase III trial. J Transl Int Med. 2023 Dec 20;11(4):423-432. doi: 10.2478/jtim-2023-0106. eCollection 2023 Dec.

Reference Type: DERIVED

PMID: 38130645 (View on PubMed)

Other Identifiers

QL0911-003

Identifier Type: -

Identifier Source: org_study_id