NCT05554913

Evaluating the Efficacy and Safety of QL0911 in the Prevention of Chemotherapy- Induced Thrombocytopenia

A Multicenter, Randomized, Double Blind, Placebo Controlled Phase 3 Study Evaluating the Efficacy and Safety of Recombinant Human Thrombopoietin Mimetic Peptide-Fc Fusion Protein for Injection (QL0911) in the Prevention of Chemotherapy- Induced Thrombocytopenia

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of QL0911 to prevention chemotherapy-induced thrombocytopenia. Thrombocytopenia is a low number of platelets in the blood. Sometimes, thrombocytopenia occurs as a side effect of chemotherapy treatments.

Detailed description

For the phase III study, a double-blind randomized, placebo controlled, parallel-group design will be conducted to evaluate the efficacy and safety of QL0911 . Each subject will be randomly assigned to either Arm A (QL0911) or Arm B (placebo) in 2:1 ratio.The primary objective is to compare the effective rates of the two treatment arms. The study will consist of a screening period of up to 4 weeks, a treatment period of 2 planned cycles of chemotherapy, a follow-up visit of 2 weeks.

Conditions

• Chemotherapy-induced Thrombocytopenia

Interventions

Type	Name	Description
DRUG	QL0911	This study is designed to study QL0911 for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for cancer
DRUG	Placebo	Placebo comparator

Timeline

• Start date: 2022-11-08
• Primary completion: 2024-02-20
• Completion: 2024-02-20
• First posted: 2022-09-26
• Last updated: 2024-10-18

Locations

1 site across 1 country: China