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This is a multi-center, open, single-arm phase IIb clinical study comprising 2 parts, which Part A will enroll about 110 subjects, and Part B will enroll about 190 subjects to investigate long-term efficacy and safety of MT1013 after treatment.The treatment duration for Part A MAD study is 52 weeks and the duration for Part B study is 26 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT1013 | Experimental | MT1013 injection administered intravenously (IV) three times per week for 52(Part A) or 26(Part B) weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT1013 | Drug | MT1013 is a novel calcimimetic agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of adverse events within 26 weeks | The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs). | Baseline up to 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with iPTH during 150-300pg/mL at week 26 | at week 26 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiang hua Chen, MD | Contact | 0571-87236844 | chenjianghua@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital College of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310003 | China |
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| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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