NCT01467947 - Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2014

Conditions

Hereditary Angioedema Types I and II

Interventions

BIOLOGICAL

Berinert, lyophilizate for IV application containing 500 IU C1-INH to be reconstituted with 10 mL water for injection

Individual treatment duration per subject is 9 months, irrespective of the number of treated attacks. Each attack that occurs in this time frame will be treated with 20 IU Berinert/kg body weight.

Trial Locations (4)

1125

Semmelweis University, Budapest

1504

"MHAT Tsaritsa Yoanna", Sofia

31-531

Jagiellonian University, Krakow

Cod 540103

Spitalul Clinic Judeţean Mureş,Secţia Clinică Medicină Internă,Compartimentul Alergologie şi Imunologie, Târgu-Mures