At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 25 enrolled
Drug / intervention
Recombinant Human C1 Inhibitordrug
Likely dose
Recombinant Human C1 Inhibitor 50 IUfrom 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.
An Open-label Exploratory Phase II Study of the Safety and Immunogenicity of Repeated "rhC1INH" Administration of 50 U/Kg in Patients With Hereditary C1 Inhibitor Deficiency ("HAE")
In Brief
A Phase 2 clinical trial evaluating Recombinant Human C1 Inhibitor for Genetic Disorders and Hereditary Angioedema. Completed, enrolled 25 participants across 2 sites in 2 countries.
Detailed Summary
Hereditary angioedema ("HAE") is a disease characterized by recurrent tissue swelling affecting various body locations. Recent literature shows that patients with frequent attacks may benefit from long-term prophylaxis. This study aims to evaluate the safety and prophylactic effect of weekly administrations of 50 IU/kg recombinant C1 Inhibitor ("rhC1INH").
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGenetic Disorders, Hereditary Angioedema
CountriesNetherlands, Romania
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2009
Enrollment StartJun 2009
Primary CompletionMar 2010
Study CompletionApr 2010
TodayJul 2026
First PostedFeb 26, 2009
Enrollment StartJun 1, 2009
Primary CompletionMar 1, 2010
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.3 years ago
Interventions
Recombinant Human C1 Inhibitordrug
50 IU/kg "rhC1INH", "IV" injection over 4 to 5 minutes, once weekly over an 8-week treatment period.