CompletedPhase 2

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

United States, Czechia, Germany57 participantsStarted 2012-01-17

Plain-language summary

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.

Who can participate

Age range2 Years – 13 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Time to Beginning of Relief Based on Visual Analogue Scale (VAS) Was Defined as the Time, in Minutes, From Time of Infusion to the Beginning of Relief.

Timeframe: The assessment of the angioedema signs by the VAS and TEQ will be performed just before start of infusion, and at T30m, T1h, T2h, T4h, T8h and T24h after study medication infusion VAS score decrease of ≥ 20 mm from baseline.

Trial details

NCT IDNCT01359969

SponsorPharming Technologies B.V.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-07-17

Results submitted2021-03-23

View on ClinicalTrials.gov More Hereditary Angioedema trials