At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 12 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.
An Open-label Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administration of CINRYZE® (C1 Esterase Inhibitor [Human]) With Recombinant Human Hyaluronidase (rHuPH20) in Subjects With Hereditary Angioedema
In Brief
A Phase 2 clinical trial evaluating CINRYZE with rHuPH20 for Hereditary Angioedema. Completed, enrolled 12 participants across 4 sites.
Detailed Summary
The objectives of the study are to: 1. Evaluate the safety and tolerability of subcutaneously administered CINRYZE with recombinant human hyaluronidase (rHuPH20) in subjects with hereditary angioedema (HAE) who previously participated in CINRYZE Study 0624-200 (NCT01095497) 2. Characterize the pharmacokinetics and pharmacodynamics of subcutaneously administered CINRYZE with rHuPH20 3. Assess the immunogenicity of CINRYZE following subcutaneous (SC) administration of CINRYZE with rHuPH20
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema
CountriesUnited States
CollaboratorsHalozyme Therapeutics
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 2011
Enrollment StartSep 2011
Primary CompletionNov 2011
TodayJul 2026
First PostedAug 31, 2011
Enrollment StartSep 12, 2011
Primary CompletionNov 28, 2011
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 14.8 years ago
Interventions
CINRYZE with rHuPH20biological