Study to Evaluate Ecallantide in Paediatric Patients With Acute Attacks of Hereditary Angioedema
NCT ID: NCT01253382
Last Updated: 2021-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE2/PHASE3
INTERVENTIONAL
2012-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* assess the safety and tolerability of ecallantide in paediatric patients for acute attacks of HAE
The secondary objectives are:
* evaluate the pharmacokinetic profile of ecallantide in paediatric patients treated for acute attacks of HAE
* assess the efficacy of ecallantide in paediatric patients treated for moderate to severe acute attacks of HAE
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Assess the Tolerability and Safety of Ecallantide in Children and Adolescents With Hereditary Angioedema
NCT01832896
A Study of Lanadelumab to Prevent Hereditary Angioedema (HAE) Attacks in Children
NCT04070326
Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE)
NCT00456508
A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema
NCT01386658
Berotralstat Treatment in Children With Hereditary Angioedema
NCT05453968
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ecallantide
ecallantide
10 - 30mg subcutaneous injection.
placebo
phosphate buffered saline
ecallantide
10 - 30mg subcutaneous injection.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ecallantide
10 - 30mg subcutaneous injection.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Physician diagnosis and history of HAE (Type I or II) including laboratory results showing C1-1NH activity below the lower limit of normal or up to 15% above the lower limit of the normal range
3. Present at the site with moderate to severe signs and symptoms of an acute attack of HAE within 8 hours of recognition of the onset of the attack. Spontaneous resolution of the attack must not have begun before the administration of study drug.
4. Must have signed informed consent by parent or caregiver.
Exclusion Criteria
2. Received treatment with ecallantide within previous 72 hours
3. Received an investigational drug or device, other than ecallantide, within 30 days prior to the screening visit
4. Pharyngeal/laryngeal symptoms
5. Mild attacks including mild edema of the extremities and mild abdominal attacks
6. Are unable or unwilling to give informed consent (parent or caregiver)
7. Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or would preclude the patient from successful completion of the study
2 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shire
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
Takeda
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-022716-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DX-88/26
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.