WHO ICTRP trial
Study of ianalumab in warm autoimmune hemolytic anemia (wAIHA) patients
CTRI/2023/08/056783 · Clinical Trials Registry India (CTRI) · Recruiting
Key facts
| Trial ID | CTRI/2023/08/056783 |
|---|---|
| Public title | Study of ianalumab in warm autoimmune hemolytic anemia (wAIHA) patients |
| Scientific title | A phase 3, randomized, double-blind, study to assess efficacy and safety of ianalumab (VAY736) versus placebo in warm autoimmune hemolytic anemia (wAIHA) patients who failed at least one line of treatment (VAYHIA) - VAYHIA |
| Primary sponsor | Novartis Healthcare Pvt Ltd |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Recruiting |
| Study type | Interventional |
| Phase | Phase 3 |
| Countries | Australia;China;France;Germany;Hungary;India;Israel;Italy;Japan;Malaysia;Singapore;Taiwan;Thailand;United Kingdom;United States of America |
| Conditions | Health Condition 1: D591- Other autoimmune hemolytic anemias |
| Interventions | Intervention1: ianalumab: Arm A (investigational): ianalumab at 3 mg/kg dose, intravenously, every 4 weeks (4 doses in total) Intervention2: ianalumab: Arm B (investigational): ianalumab at 9 mg/kg dose, intravenously, every 4 weeks (4… |
| Registration date | Aug 22, 2023 |
| Target size | 90 |
| Secondary IDs | 2022-001773-31;CVAY736O12301 Version No 02 dated 29SEP2022 |
| Registry page | ctri.nic.in |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: