At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 47 enrolled
Drug / intervention
CINRYZE with rHuPH20biological
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.
A Phase 2, Randomized, Double-Blind, Multicenter, Dose-Ranging, Crossover Study to Evaluate the Safety and Efficacy of Subcutaneous Administration of CINRYZE® (C1 Esterase Inhibitor [Human]) With Recombinant Human Hyaluronidase (rHuPH20) for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
In Brief
A Phase 2 clinical trial evaluating CINRYZE with rHuPH20 for Hereditary Angioedema (HAE). Completed, enrolled 47 participants across 23 sites in 4 countries.
Detailed Summary
The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of two doses of CINRYZE with recombinant human hyaluronidase (rHuPH20) administered by subcutaneous (SC) injection to prevent angioedema attacks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema (HAE)
CountriesGermany, Spain, Sweden, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 2012
Enrollment StartFeb 2013
Primary CompletionSep 2013
TodayJul 2026
First PostedDec 25, 2012
Enrollment StartFeb 4, 2013
Primary CompletionSep 13, 2013
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 13.5 years ago
Interventions
CINRYZE with rHuPH20biological