Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-01-05 @ 5:58 PM
Study NCT ID:
NCT05355766
Status:
COMPLETED
Last Update Posted:
2025-03-14
First Post:
2022-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Clinical Study of CN128 in Thalassemia With Sever Liver Iron Overloaded Patients
Sponsor:
Hangzhou Zede Pharma-Tech Co., Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: