Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

January 17, 2012

Primary Completion Date

July 17, 2017

Study Completion Date

July 17, 2017

Conditions
Hereditary Angioedema
Interventions
DRUG

rhC1INH

Patients up to 84 kg will receive one i.v. injection of Ruconest at a dose of 50 U/kg. The reconstituted solution should be administered as a slow i.v. injection over approximately 5 minutes. Patients of 84 kg body weight or greater will receive one i.v. injection of Ruconest at the dose of 4200 U (2 vials).

Trial Locations (16)

1000

University Clinic Of Dermatology Skopje, Skopje

1131

Heim Pál Gyermekkórház, II. számú Gyermek Belgyógyászati Osztály, Budapest

10117

Charité - Universitätsmedizin Berlin, Berlin

84131

Azienda Ospedaliera Universitaria S. Giovanni di Dio e Ruggi d'Aragona, Salerno

97015

Portland Clinical Research/AAIM Care, LLC, Portland

304 60 Plzen

UIA FN Plzen ( Institute of Immunology and Allergology), Faculty Hospital Plzen, Pilsen

150 06 Prague

University Hospital Motol, Institute of Immunology, Prague

Unknown

Klinikum Rechts der Isar, Technical University Munich, Munich

Bnei Zion Hospital, Haifa

Souraski Medical Center, Tel Aviv

Sheba Medical Center, Tel Litwinsky

Hospital Luigi Sacco, Milan

Pediatric Hospital, Krakow

Pediatric Hospital, Lublin

Mures County Clinical Hospital, Târgu Mureş

036 59 Martin

Klinika detí a dorastu, Univerzitna nemocnica Martin, Martin

Sponsors
All Listed Sponsors
lead

Pharming Technologies B.V.

INDUSTRY

NCT01359969 - Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients | Biotech Hunter | Biotech Hunter