CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 57 enrolled
Drug / intervention
rhC1INHdrug
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.

Search/NCT01359969
NCT01359969Phase 2Completed
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Open-label, Phase II, Single Arm Study to Evaluate the Safety, Immunogenicity, Pharmacokinetics and Efficacy of rhC1INH for the Treatment of Acute Attacks in Pediatric Patients With Hereditary Angioedema, From 2-13 Years of Age

Pharming Technologies B.V.·interventional·Posted May 25, 2011·Updated Mar 29, 2024

In Brief

A Phase 2 clinical trial evaluating rhC1INH for Hereditary Angioedema. Completed, enrolled 57 participants across 16 sites in 10 countries.

Detailed Summary

This open-label study is being conducted to confirm the safety, pharmacokinetic profile and efficacy of Ruconest at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in patients, from 2 up to and including 13 years of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema
CountriesCzechia, Germany, Hungary, Israel, Italy, North Macedonia, Poland, Romania, Slovakia, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 25, 2011
Enrollment StartJan 17, 2012
Primary CompletionJul 17, 2017
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 15.1 years ago

Interventions

rhC1INHdrug

Patients up to 84 kg will receive one i.v. injection of Ruconest at a dose of 50 U/kg. The reconstituted solution should be administered as a slow i.v. injection over approximately 5 minutes. Patients of 84 kg body weight or greater will receive one i.v. injection of Ruconest at the dose of 4200 U (2 vials).