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Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05355766
Study type Interventional
Source Hangzhou Zede Pharma-Tech Co., Ltd.
Contact Jianmin Luo, PhD
Phone +86-13517667021
Email jmluo@aliyun.com
Status Recruiting
Phase Phase 2
Start date June 2, 2022
Completion date December 31, 2024

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