Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients
Completed · Phase 2
Conditions studied: Hereditary Angioedema
In brief
This open-label study is being conducted to confirm the safety, pharmacokinetic profile and efficacy of Ruconest at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in patients, from 2 up to and including 13 years of age.
Key facts
- Study ID
- NCT01359969
- Run by
- Pharming Technologies B.V.
- People needed
- 57
- Starts
- 2012-01-17
- Expected to finish
- 2017-07-17
- Last updated by the study team
- 2024-03-29
Who can join
Age: 2 and older, up to 13. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- From 2 up to and including 13 years of age
- Clinical and laboratory confirmed diagnosis of HAE (baseline C1INH activity <50% of normal)
- Signed written Informed Consent Form (ICF)(parental permission) signed by the legal guardian(s)
- Clinical symptoms of an acute HAE attack
- Onset of eligible symptoms within 5 hours from the moment at which medical evaluation to determine eligibility has occurred
- Attack severity moderate or greater, as rated by the investigator
You may not qualify if…
- A diagnosis of acquired C1INH deficiency (AAE)
- A medical history of allergy to rabbits or rabbit-derived products or positive anti-rabbit epithelium (dander) immunoglobuline E (IgE) test
Where it is running
- Portland Clinical Research/AAIM Care, LLC — Portland, Oregon, United States
- UIA FN Plzen ( Institute of Immunology and Allergology), Faculty Hospital Plzen — Pilsen, Alej Svobody 80, Czechia
- University Hospital Motol, Institute of Immunology — Prague, V Úvalu 84, Czechia
- Charité - Universitätsmedizin Berlin — Berlin, Charitéplatz 1, Germany
- Klinikum Rechts der Isar, Technical University Munich — Munich, Germany
- Heim Pál Gyermekkórház, II. számú Gyermek Belgyógyászati Osztály — Budapest, Madarász Utca 22-24, Hungary
- Bnei Zion Hospital — Haifa, Israel
- Souraski Medical Center — Tel Aviv, Israel
- Sheba Medical Center — Tel Litwinsky, Israel
- Hospital Luigi Sacco — Milan, Italy
- Azienda Ospedaliera Universitaria S. Giovanni di Dio e Ruggi d'Aragona — Salerno, Italy
- University Clinic Of Dermatology Skopje — Skopje, North Macedonia
- Pediatric Hospital — Krakow, Poland
- Pediatric Hospital — Lublin, Poland
- Mures County Clinical Hospital — Târgu Mureş, Romania
- Klinika detí a dorastu, Univerzitna nemocnica Martin — Martin, Kollárova 2, Slovakia
Full record on ClinicalTrials.gov
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