A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema
This trial is active, not recruiting.
|Condition||hereditary angioedema (hae)|
|Start date||November 2011|
|End date||December 2017|
|Trial size||30 participants|
|Trial identifier||NCT01386658, 2011-003825-81, HGT-FIR-086|
HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single subcutaneous (SC) administration of icatibant in approximately 30 pediatric subjects with Hereditary Angioedema (HAE) during an initial acute attack.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Los Angeles, CA||Children's Hospital Los Angeles||no longer recruiting|
|Tampa, FL||University of South Florida||no longer recruiting|
|Shreveport, LA||Breathe America||no longer recruiting|
|Chevy Chase, MD||Institute for Asthma and Allergy, PC||no longer recruiting|
|Boston, MA||Boston Children's Hospital||no longer recruiting|
|St. Louis, MO||Washington University School of Medicine||no longer recruiting|
|Cincinnati, OH||Bernstein Clinical Research Center, LLC||no longer recruiting|
|Toledo, OH||Toledo Institute of Clinical Research||no longer recruiting|
|Oklahoma City, OK||Oklahoma Institute of Allergy and Asthma Clinical Research, LLC||no longer recruiting|
|Lake Oswego, OR||Allergy Asthma Dermatology Research Center||no longer recruiting|
|Hershey, PA||Penn State University||no longer recruiting|
|Dallas, TX||AARA Research Center||no longer recruiting|
|New South Wales, Australia||Campbelltown Hospiital||no longer recruiting|
|Graz, Austria||Medizinische Universität Graz Hautklinik||no longer recruiting|
|Hamilton, Canada||McMaster University||no longer recruiting|
|Bogota D.c., Colombia||Hospital Infantil Universitario de San Jose||no longer recruiting|
|Frankfurt, Germany||Klinikum der Johann Wolfgang Goethe University||no longer recruiting|
|Mainz, Germany||Johannes-Gutenberg University Clinical Research Center||no longer recruiting|
|Walldorf, Germany||HZRM Hämophilie Zentrum Rhein Main GmbH||no longer recruiting|
|Budapest, Hungary||Heim Pal Childrens Hospital||no longer recruiting|
|Haifa, Israel||Bnai Zion Medical Center, Allergy and Immunology Institute||no longer recruiting|
|Tel Aviv, Israel||Tel Aviv Sourasky Medical Center, Pulmonology and Allergy Unit||no longer recruiting|
|Tel Hashomer, Israel||Sheba Medical Center Allergy and Immunology Angioedema Center||no longer recruiting|
|Naples, Italy||University of Naples Federico II, Dipartimento di Medicina Interna||no longer recruiting|
|Madrid, Spain||Unidad de Alergia, Edif. Consultas Externas, Planta Baja HOSPITAL UNIVERSITARIO LA PAZ||no longer recruiting|
|Valencia, Spain||University Hospital, Pediatric Pulmonology and Allergy Unit||no longer recruiting|
|Intervention model||single group assignment|
Single dose of icatibant 0.4 mg/kg subcutaneous(SC) up to a maximal dose of 30 mg
Pharmacokinetic (PK) Profile after a single SC injection (in prepubertal children with an acute attack of HAE and pubertal/postpubertal children with or without an acute attack of HAE)
time frame: Administration through 6 hours
Safety of a single SC dose of icatibant
time frame: Treatment through day 90
Time to onset of relief of symptoms and time to minimal symptoms, as measured byinvestigator- and subject-reported outcomes (only for subjects treated with icatibant during a HAE attack)
time frame: Treatment through 8 hours
Proportion of subjects with worsened intensity of clinical HAE symptoms between 2 and 4 hours after treatment with icatibant for subjects who have experienced HAE attack only
time frame: Treatment through 4 hours
Incidence of rescue medication use for subjects who have experienced HAE attack only
time frame: Treatment through day 90
All participants from 2 years up to 17 years old.
- Two through <18 years of age at the time of first HAE attack.
- Prepubertal and pubertal/postpubertal subjects experiencing and acute cutaneous, abdominal, or laryngeal HAE attack treated with icatibant as part of this study.
- Pubertal/postpubertal subjects with HAE who are treated with icatibant, but not during an attack.
- Documented diagnosis of HAE Type I or II.
- Informed consent (and subject assent as appropriate) signed by the subject's parent(s)or legal guardian(s).
- Diagnosis of angioedema other than HAE.
- Participation in another clinical trial that involves the use of any investigational product (drug or device)within 30 days prior to study enrollment or at any time during the study.
- Any known factor/disease that might interfere with the treatment compliance, study conduct,or result interpretation.
- Congenital or acquired cardiac anomalies that interfere significantly with cardiac function.
- Treatment with ACE inhibitors within 7 days prior to treatment.
- Use of hormonal contraception within the 90 days prior to treatment.
- Androgen use (eg, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within the 90 days prior to treatment.
- Pregnancy or breastfeeding.
- A physical condition that interferes with pubertal status determination.
|Official title||A Multicenter, Open-Label, Non-Randomized Study to Assess the Pharmacokinetics, Tolerability, and Safety of a Single Subcutaneous Administration of Icatibant in Children and Adolescents With Hereditary Angioedema|
|Description||Study HGT-FIR-086 will enroll 30 subjects from 2 to less than 18 years of age, divided into 2 groups: prepubertal and pubertal/postpubertal. At least 10 prepubertal children and at least 20 adolescents (including 10 treated during a HAE attack) must be enrolled in the study. After a qualifying screening period, the PK, safety/tolerability, and efficacy of treatment with SC icatibant will be evaluated in at least 20 subjects (10 prepubertal and 10 pubertal/postpubertal subjects) who present with cutaneous, abdominal, or laryngeal symptoms of an acute attack of HAE. The PK and safety/tolerability of SC icatibant will be evaluated in at least 10 additional pubertal/postpubertal subjects who meet screening criteria and receive treatment with SC icatibant in the absence of a current acute HAE attack. The planned duration of active participation for subjects who present with an initial attack of acute HAE will consist of treatment with a single subcutaneous injection of icatibant on Day 1 through follow up at day 90. After having received initial treatment with icatibant, either during or in the absence of an attack, at least 10 pubertal/postpubertal subjects who subsequently experience an acute HAE attack may continue to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant-treated attacks. The period of active participation in the study for prepubertal subjects will be approximately 90 days, while that for pubertal/postpubertal subjects could be a maximum of approximately 270 or 360 days (3 separate active periods of approximately 90 days for those treated with icatibant during an attack; 4 separate active periods for those treated without an attack), with each active period separated by periods of inactive participation of variable duration.|
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