At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 9 enrolled
Drug / intervention
CINRYZEbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-Label, Single-Dose Study to Evaluate the Response and Pharmacokinetics/Pharmacodynamics of Different Doses of CINRYZE® [C1 Inhibitor (Human)] For Treatment of Acute Angioedema Attacks in Children Less Than 12 Years of Age With Hereditary Angioedema
In Brief
A Phase 2 clinical trial evaluating CINRYZE for Hereditary Angioedema (HAE). Completed, enrolled 9 participants across 11 sites in 3 countries.
Detailed Summary
The objectives of this study were to evaluate: (1) the dose response and (2) the pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous (IV) administration of CINRYZE for the treatment of acute angioedema attacks in children above and below 25 kg and less than 12 years of age with hereditary angioedema (HAE); and (3) to determine the safety and tolerability following IV administration of CINRYZE in this study population.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema (HAE)
CountriesGermany, Hungary, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2010
Enrollment StartJun 2010
Primary CompletionApr 2012
TodayJul 2026
First PostedMar 30, 2010
Enrollment StartJun 2, 2010
Primary CompletionApr 17, 2012
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 16.3 years ago
Interventions
CINRYZEbiological