WHO ICTRP trial
A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and…
EUCTR2006-003148-51-GB · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2006-003148-51-GB |
|---|---|
| Public title | A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency - F13CD-1725 |
| Scientific title | A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII Deficiency - F13CD-1725 |
| Primary sponsor | Novo Nordisk A/S |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | France;Finland;Spain;Austria;Germany;Italy;United Kingdom |
| Conditions | Congenital Factor XIII Deficiency MedDRA version: 9.1 Level: LLT Classification code 10010432 Term: Congenital deficiency of other clotting factors MedDRA version: 9.1 Level: LLT Classification code 10061992 Term: Haemophilia MedDRA… |
| Interventions | Product Name: Recombinant Factor XIII (rFXIII) Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Catridecacog CAS Number: 606138-08-3 Current Sponsor code: NN1841 Other descriptive name: Recombinant Factor XIII… |
| Registration date | Sep 5, 2008 |
| Target size | 45 |
| Secondary IDs | F13CD-1725 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- Yes Results available
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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: