Overview

This trial has been completed.

Condition hereditary angioedema
Treatment phone to the call center
Phase phase 4
Sponsor Assistance Publique - Hôpitaux de Paris
Start date March 2013
End date September 2016
Trial size 200 participants
Trial identifier NCT01679912, 2012-A00044-39, P110109

Summary

This clinical trial aims to compare morbidity and cost associated with acute attacks of hereditary angioedema in patients with an intervention based on a support after a phone call to the call center (SOS HAE) from a group of patients does not change their practice.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
recommendations to phone to the call center for all the patients who have an acute attack
phone to the call center
recommendations to phone to the call center for all the patients who have an acute attack
(No Intervention)
usual strategy. No intervention (patients does not change their practice)

Primary Outcomes

Measure
Number of hospital admissions for angioedema attack- no (%)
time frame: at 2 years

Secondary Outcomes

Measure
Number of ICU admissions - no (%)
time frame: at 2 years
Number of ED admissions - no (%)
time frame: at 2 years
Number of hospital admissions for others causes - no (%)
time frame: at 2 years
Number of intubations - no (%)
time frame: at 2 years
Number of EMS interventions - no (%)
time frame: at 2 years
Number of working days lost
time frame: at 2 years
Mortality - no (%)
time frame: at 2 years
Mortality for angioedema attack- no (%)
time frame: at 2 years
Cost of angioedema attacks
time frame: at 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria

  • Patients with an hereditary angioedema followed in a reference center for bradykinin angioedema (CRéAk)
  • Patient's age ≥ 18 years
  • Consent to the participation in the study
  • Affiliated to social security

Exclusion Criteria

  • pregnant woman
  • recent history of myocardial infarction
  • recent history of stroke
  • allergy to icatibant or C1 inhibitor concentrate

Additional Information

Official title Hereditary Angioedema : Interest From the Use of a Call Center During the Attacks.
Principal investigator Frédéric ADNET, MD,PhD
Description Investigators propose a study to determine whether a call center for an acute attack of HAE associated with intervention recommendations based on systematic early treatment (self-administration at home or by a caregiver) would reduce the morbidity and the socioeconomic impact.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.