WHO ICTRP trial
A Phase 3 Open Label, Multicenter, Extension Study to Assess the Safety and…
NL-OMON47544 · Overview of Medical Research in the Netherlands (NL-OMON) · Not Recruiting
Key facts
| Trial ID | NL-OMON47544 |
|---|---|
| Public title | A Phase 3 Open Label, Multicenter, Extension Study to Assess the Safety and Efficacy of Recombinant Coagulation Factor VIII (rVIII-SingleChain, CSL627) in Subjects with Severe Hemophilia A |
| Scientific title | A Phase 3 Open Label, Multicenter, Extension Study to Assess the Safety and Efficacy of Recombinant Coagulation Factor VIII (rVIII-SingleChain, CSL627) in Subjects with Severe Hemophilia A - CSL627_3001 |
| Primary sponsor | CSL Behring GmbH |
| Registry | Overview of Medical Research in the Netherlands (NL-OMON) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | 3 |
| Countries | The Netherlands |
| Conditions | Hemophilia A;10005330;Hemophilia A |
| Interventions | rVIII-SingleChain is supplied as a lyophilized powder to be reconstituted with diluent (Sterile Water for Injection / infusion). After reconstitution, rVIII -SingleChain is administered as an IV infusion. ;CSL627_3001;Hemophilia… |
| Registration date | Jan 16, 2020 |
| Target size | 14 |
| Secondary IDs | 2013-003262-13;NL49424.018.14 |
| Registry page | onderzoekmetmensen.nl |
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: