Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT05355766
Brief 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.
Study:
NCT05355766
Study Brief:
Protocol Section:
NCT05355766