NCT05355766

Long-term Clinical Study of CN128 in Thalassemia With Sever Liver Iron Overloaded Patients

Phase IIb Clinical Study to Assess the Safety and Efficacy of CN128 Tablets in the Treatment of Iron Overload in Transfusion Dependent Thalassemia With Sever Liver Iron Overloaded Patients Aged 16 and Above

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Hangzhou Zede Pharma-Tech Co., Ltd. · Academic / Other
• Sex: All
• Age: 16 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The safety and efficacy of CN128 is studied in thalassaemia with sever liver iron overloaded patients.

Detailed description

1. The study is designed as a single arm and opened phase IIb clinical trial, so as to investigate the safety and efficacy of CN128. 2. A total of 50 eligible subjects are planned to be enrolled, and orally administration of CN128 for 52 weeks according to the administration plan. 3. Administration plan: The trial will start with the lower dose of CN128 (10 mg/kg body weight \[bw\], bid) for one week. If no unacceptable toxicity associated with CN128 is found, the subjects will be given 15 mg/kg body weight \[bw\], bid for one week. If no unacceptable toxicity associated with CN128 is found, the subjects will be given 20 mg/kg body weight \[bw\], bid for two weeks. If no unacceptable toxicity associated with CN128 is found, the subjects will be given 25 mg/kg body weight \[bw\], bid for two weeks. If no unacceptable toxicity associated with CN128 is found, the subjects will be given 30 mg/kg body weight \[bw\], bid for two weeks. If no unacceptable toxicity associated with CN128 is found, the subjects will be given 30 mg/kg body weight \[bw\], bid to Week 52. Dosage will be adjusted according to subject status and study plan.

Conditions

• Thalassemia
• Iron Overload

Interventions

Type	Name	Description
DRUG	CN128 Tablets	Iron chelator, oral tablets

Timeline

• Start date: 2022-06-13
• Primary completion: 2024-09-23
• Completion: 2025-03-06
• First posted: 2022-05-02
• Last updated: 2025-03-14

Locations

1 site across 1 country: China