WHO ICTRP trial
A Clinical Study of the Long-term Use of Hetero Denosumab in Patients of Bone…
CTRI/2023/09/057660 · Clinical Trials Registry India (CTRI) · Recruiting
Key facts
| Trial ID | CTRI/2023/09/057660 |
|---|---|
| Public title | A Clinical Study of the Long-term Use of Hetero Denosumab in Patients of Bone Cancer |
| Scientific title | A Phase IIIb, Prospective, Multicenter, Parallel, Assessor Blinded Extension Study to Evaluate the long-term Efficacy, Immunogenicity, Safety of Subcutaneous Injection of Denosumab (Hetero) in patients with bone metastases from solid tumours - Nil |
| Primary sponsor | Hetero Biopharma Limited |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Recruiting |
| Study type | Interventional |
| Phase | Phase 3 |
| Countries | India |
| Conditions | Health Condition 1: C795- Secondary malignant neoplasm of bone and bone marrow |
| Interventions | Intervention1: Injection Hetero-Denosumab: Injection: 120 mg/1.7 mL (70 mg/mL) solution in a single dose vial every 4 weeks for 24 weeks Control Intervention1: Injection Reference-Denosumab (Amgen): Injection: 120 mg/1.7 mL (70 mg/mL)… |
| Registration date | Sep 14, 2023 |
| Target size | 60 |
| Secondary IDs | HCR/IIIb/DENOSOLEXT/01/2023 Version 1.0 Dated 08-Mar-2023 |
| Registry page | ctri.nic.in |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: