CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
C1-esterase inhibitor - single intravenous dose +3 morebiological
Likely dose
C1-esterase inhibitor 20 units/kg intravenously as single loading dose, then subcutaneous low/medium/high doses twice weekly for 4 weeksAI-extracted
Key inclusion· 4
  • ✓Ages 18 years or older
  • ✓Laboratory-confirmed hereditary angioedema type I or II
  • ✓≤2 hereditary angioedema attacks per month in the last 3 months
  • ✓Body weight 50.0–110.0 kg
Key exclusion· 7
  • ✕Currently receiving prophylactic C1-esterase inhibitor therapy
  • ✕Recent C1-esterase inhibitor, ecallantide, icatibant, or blood products within 7 days
  • ✕Plans to use recombinant C1-esterase inhibitor or fresh frozen plasma for acute HAE treatment during study
  • ✕Androgen therapy within 30 days

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01576523
NCT01576523Phase 2Completed
CompareCT.gov

An Open-label, Cross-over, Dose-ranging Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of the Subcutaneous Administration of a Human Plasma-derived C1-esterase Inhibitor in Subjects With Hereditary Angioedema

CSL Behring·interventional·Posted Apr 12, 2012·Updated Feb 1, 2021

In Brief

A Phase 2 clinical trial evaluating C1-esterase inhibitor - single intravenous dose, C1-esterase inhibitor - subcutaneous low dose, and 2 other interventions for Hereditary Angioedema Types I and II. Completed, enrolled 18 participants across 8 sites in 2 countries.

Detailed Summary

The aim of the study is to assess what happens to C1-esterase inhibitor that is administered under the skin of subjects with hereditary angioedema. Three different dosing regimens of C1-esterase inhibitor will be assessed. Each subject will be assigned to receive 2 of the 3 dosing regimens, each for 4 weeks. The activity and concentration of C1-esterase inhibitor in the blood will be measured during each 4-week period. The study will also examine how well C1-esterase inhibitor administered under the skin is tolerated by the subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema Types I and II
CountriesGermany, United States
CollaboratorsParexel

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 12, 2012
Enrollment StartApr 1, 2012
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.2 years ago

Interventions

C1-esterase inhibitor - single intravenous dosebiological

A single intravenous dose of C1-esterase inhibitor (Berinert) at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor.

C1-esterase inhibitor - subcutaneous low dosebiological

A low dose of C1-esterase inhibitor will be administered subcutaneously twice a week for four weeks.

C1-esterase inhibitor - subcutaneous medium dosebiological

A medium dose of C1-esterase inhibitor will be administered subcutaneously twice a week for four weeks.

C1-esterase inhibitor - subcutaneous high dosebiological

A high dose of C1-esterase inhibitor will administered subcutaneously twice a week for four weeks.