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NCT01679912 Clinical Trial

A Call Center During HAE Attacks (SOS HAE)

Hereditary Angioedema Clinical Trial

— SOS AOH  

Official title:
Hereditary Angioedema : Interest From the Use of a Call Center During the Attacks.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01679912
Other study ID # P110109
Secondary ID 2012-A00044-39
Status Completed
Phase Phase 4
First received August 21, 2012
Last updated December 12, 2016
Start date March 2013
Est. completion date September 2016

Study information
Verified date December 2016
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• phone to the call center
recommendations to phone to the call center for all the patients who have an acute attack

Locations
Country Name City State
France SAMU 93 - Hôpital Avicenne Bobigny Ile de France

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of hospital admissions for angioedema attack- no (%) at 2 years Yes
Secondary Number of ICU admissions - no (%) at 2 years Yes
Secondary Number of ED admissions - no (%) at 2 years Yes
Secondary Number of hospital admissions for others causes - no (%) at 2 years Yes
Secondary Number of intubations - no (%) at 2 years Yes
Secondary Number of EMS interventions - no (%) at 2 years Yes
Secondary Number of working days lost at 2 years Yes
Secondary Mortality - no (%) at 2 years Yes
Secondary Mortality for angioedema attack- no (%) at 2 years Yes
Secondary Cost of angioedema attacks at 2 years No
See also
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Completed NCT00997204 - EASSI - Evaluation of the Safety of Self-Administration With Icatibant Phase 3
Completed NCT00438815 - Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks Phase 3
Completed NCT00748202 - Berinert P Study of Subcutaneous Versus Intravenous Administration Phase 3
Completed NCT01426763 - A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase Phase 2
Terminated NCT04091113 - Hereditary Angioedema Kininogen Assay
Completed NCT00432510 - Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects Phase 1
Completed NCT03712228 - A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE) Phase 2
Active, not recruiting NCT05453968 - Berotralstat Treatment in Children With Hereditary Angioedema Phase 3
Recruiting NCT05511922 - PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial Phase 3
Recruiting NCT05505916 - An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE) Phase 3
Not yet recruiting NCT02159430 - Hereditary AngioEdema, Neurobiology and Psychopathology N/A
Completed NCT02303626 - 12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks Phase 2/Phase 3
Completed NCT01984788 - Safety and Efficacy of Oral BCX4161 as a Prophylactic Treatment for HAE Phase 2
Completed NCT04888650 - Assessment of the State of Health, Quality of Life and Expectations of Patients With Hereditary Angioedema
Completed NCT02448264 - First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers Phase 1
Completed NCT05118958 - Phase 1 Crossover Study in Healthy Subjects to Evaluate the PK Profile of KVD824 Following Single and Multiple Doses of Modified Release (MR) Formulations Phase 1
Active, not recruiting NCT04739059 - Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks Phase 3
Completed NCT02819102 - An Open-label Drug-Drug Interaction Study to Evaluate the Effect of BCX7353 on Cytochrome P450 Enzyme Activity Using Probe Substrates Phase 1
Completed NCT01005888 - C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks Phase 3