A Phase 4 interventional study of Ruconest in Hereditary Angioedema, sponsored by Bernstein Clinical Research Center. Completed at 2 sites in United States. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2024-11-15.
Sponsored by Bernstein Clinical Research Center · Phase 4, Interventional, and Prevention
To assess the efficacy of recombinant human C1-esterase inhibitor in the management of HAE prodrome for preventing the progression from prodrome to an acute angioedema attacks. Subjects will either receive Ruconest after the first 2 prodromes or during the last 2 prodromes. 5 clinic visits will occur within 24 hours of a prodrome. Subjects will complete prodrome severity and angioedema attack diaries
After screening, subjects will be followed in the study for four consecutive prodromes. For prodromes designed to be treated with Ruconest, the drug will be administered within 12 hours of prodromal onset and prior to the onset of objective selling. Ruconset will be self-administered at home or by a healthcare professional at the recommended dose of 50 IU/kg body weight with maximum dose of 4200 IU as a slow IV injection over 5 minutes Subjects will be randomized into two arms after enrollment. Subjects in Arm A receives Ruconest after 1st and 2nd prodrome and no Ruconest after 3rd and 4th prodromes. Subjects in Arm B receive no Ruconest after 1st and 2nd prodrome and Ruconest after 3rd and 4th prodromes.
173 studies on the registry are indexed under Angioedemas, Hereditary; 25 are open to participants now.
This study's enrollment of 5 is below the median of 48 across 117 interventional studies indexed under Angioedemas, Hereditary.
Browse Angioedemas, Hereditary studies →Bernstein Clinical Research Center is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
open-label Ruconest
Biological: Ruconest
No Ruconest given
recombinant human C1-esterase inhibitor
The primary endpoint was the difference in response rates in preventing HAE attacks between Conestat Alfa®-treated vs. untreated HAE prodrome events.
A mixed model for repeated measures was used to determine the statistical significance of Conestat Alfa®'s clinical efficacy for treating the HAE prodrome versus the acute attack.
Time frame: up to 12 months from start of study
Plan to share: No — not needed for manuscript
No publications or documents are linked to this record.
Ran from Aug 2018 to primary completion in Apr 2022, 44 months.
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Conestat alfa
Bernstein Clinical Research Center