At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 8 enrolled
Drug / intervention
CINRYZE 500 U +1 moredrug
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 3, Open-label, Single-period Study to Evaluate the Safety and Treatment Effect of Intravenous Administration of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of Breakthrough Attacks in Japanese Subjects With Hereditary Angioedema (HAE)
In Brief
A Phase 3 clinical trial evaluating CINRYZE 500 U and CINRYZE 1000 U for Hereditary Angioedema (HAE). Completed, enrolled 8 participants across 10 sites.
Detailed Summary
The purpose of this study is to determine if an investigational treatment is safe and well tolerated when administered by intravenous (IV) infusion in Japanese subjects with HAE.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema (HAE)
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2016
Enrollment StartSep 2016
Primary CompletionJun 2017
TodayJul 2026
First PostedAug 12, 2016
Enrollment StartSep 8, 2016
Primary CompletionJun 23, 2017
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 9.9 years ago
Interventions
CINRYZE 500 Udrug
IV infusion administered twice weekly
CINRYZE 1000 Udrug
IV infusion administered twice weekly