WHO ICTRP trial
Efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to…
EUCTR2017-000348-17-BE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2017-000348-17-BE |
|---|---|
| Public title | Efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care for the treatment of refractory antibody mediated rejection (AMR) in adult renal transplant recipients |
| Scientific title | A Double-blind, Randomized-Withdrawal, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Human Plasma-Derived C1-esterase Inhibitor as Add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection in Adult Renal Transplant Recipients |
| Primary sponsor | CSL Behring LLC |
| 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;United States;European Union;Spain;Belgium;Netherlands;Germany;United Kingdom |
| Conditions | Refractory AMR in adult renal transplant participants MedDRA version: 20.0 Level: PT Classification code 10023439 Term: Kidney transplant rejection System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Body processes [G]… |
| Interventions | Trade Name: Berinert 1500 Product Name: C1-INH [C1-esterase Inhibitor, Human (500 IU/mL)] Product Code: C1-INH Pharmaceutical Form: Lyophilisate and solvent for solution for injection INN or Proposed INN: C1-esterase inhibitor Current… |
| Registration date | Apr 24, 2017 |
| Target size | 90 |
| Secondary IDs | CSL842_3001 |
| Registry page | clinicaltrialsregister.eu |
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: