WHO ICTRP trial
Safety, efficacy and exposure of subcutaneously administered NNC0365-3769 (Mim8)…
JPRN-jRCT2031220670 · Japan Primary Registries Network (JPRN) · Recruiting
Key facts
| Trial ID | JPRN-jRCT2031220670 |
|---|---|
| Public title | Safety, efficacy and exposure of subcutaneously administered NNC0365-3769 (Mim8) prophylaxis in children with haemophilia A with or without FVIII inhibitors (NN7769-4516) |
| Scientific title | Safety, efficacy and exposure of subcutaneously administered NNC0365-3769 (Mim8) prophylaxis in children with haemophilia A with or without FVIII inhibitors (NN7769-4516) - Frontier 3 |
| Primary sponsor | Esaki Risa |
| Registry | Japan Primary Registries Network (JPRN) |
| Recruitment status | Recruiting |
| Study type | Interventional |
| Phase | 3 |
| Countries | Canada;Japan;China;Japan;Germany;Japan;India;Japan;Israel;Japan;Italy;Japan;Korea;Japan;Lithuania;Japan;Netherlands;Japan;Poland;Japan;Portugal;Japan;Russian;Japan;South… |
| Conditions | children with haemophilia A with or without FVIII inhibitors |
| Interventions | Treatment period is consistent of part1 and part2. During part1, study product is administered weekly. The treatment period is 26 weeks. A loading dose will be administered once followed by once-weekly maintenance doses in part1. After… |
| Registration date | Feb 3, 2023 |
| Target size | 70 |
| Secondary IDs | NCT05306418 |
| Registry page | jrct.niph.go.jp |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: