CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 75 enrolled
Drug / intervention
rhC1INH +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.

Search/NCT01188564
NCT01188564Phase 3Completed
CompareCT.gov

A Phase III Randomized, Double-blind, Placebo-controlled Study With an Open-label Extension Evaluating the Efficacy, Safety and Immunogenicity of Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks of Angioedema in Patients With HAE

Pharming Technologies B.V.·interventional·Posted Aug 25, 2010·Updated Aug 7, 2015

In Brief

A Phase 3 clinical trial evaluating rhC1INH and Placebo (Saline) for Hereditary Angioedema. Completed, enrolled 75 participants across 27 sites in 11 countries.

Detailed Summary

This study is being conducted to confirm the efficacy, safety, and immunogenicity of recombinant human C1 inhibitor (rhC1INH) at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in Hereditary Angioedema (HAE) patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema
CountriesBulgaria, Canada, Hungary, Israel, Italy, North Macedonia, Poland, Romania, Serbia, South Africa, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 25, 2010
Enrollment StartJan 1, 2011
Primary CompletionDec 1, 2012
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.9 years ago

Interventions

rhC1INHdrug

One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.

Placebo (Saline)drug

One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment