WHO ICTRP trial
REVERSAL OF ANTICOAGULANT EFFECT OF DABIGATRAN® BY PROTHROMBIN COMPLEX…
EUCTR2014-002204-24-NL · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2014-002204-24-NL |
|---|---|
| Public title | REVERSAL OF ANTICOAGULANT EFFECT OF DABIGATRAN® BY PROTHROMBIN COMPLEX CONCENTRATE (BERIPLEX®) ASSESSED WITH A NOVEL METHOD OF BLOOD LOSS MEASUREMENT |
| Scientific title | REVERSAL OF ANTICOAGULANT EFFECT OF DABIGATRAN® BY PROTHROMBIN COMPLEX CONCENTRATE (BERIPLEX®) ASSESSED WITH A NOVEL METHOD OF BLOOD LOSS MEASUREMENT - REVERSAL OF DABIGATRAN® BY PROTHROMBIN COMPEX CONCENTRATE (BERIPLEX®). |
| Primary sponsor | University Medical Center Groningen |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Netherlands |
| Conditions | Healthy male volunteers. Study assessing the effect of a single 50IU/Kg dose of Beriplex on the anticoagulant effect of Dabigatran. This is of interest when rapid reversal of its effect is mandated. E.g. in the case of Bleeding or when… |
| Interventions | Trade Name: Beriplex P/N 500 Product Name: Beriplex (Prothrombin complex concentrate) Product Code: RVG 101094 Pharmaceutical Form: Solution for injection/infusion Pharmaceutical form of the placebo: Solution for injection/infusion Route of… |
| Registration date | Jan 10, 2014 |
| Target size | 12 |
| Secondary IDs | 1160.203;49443;12NAT01721 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: