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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
NCT01359969 |
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Date of registration:
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19/05/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients
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Scientific title:
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Open-label, Phase II, Single Arm Study to Evaluate the Safety, Immunogenicity, Pharmacokinetics and Efficacy of rhC1INH for the Treatment of Acute Attacks in Pediatric Patients With Hereditary Angioedema, From 2-13 Years of Age |
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Date of first enrolment:
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January 17, 2012 |
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Target sample size:
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57 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT01359969 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Czech Republic
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Czechia
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Germany
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Hungary
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Israel
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Italy
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Macedonia, The Former Yugoslav Republic of
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North Macedonia
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Poland
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Romania
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Slovakia
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United States
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Contacts
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Name:
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Anurag Relan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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VP Clinical Research & Medical Affairs at Pharming |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- From 2 up to and including 13 years of age
- Clinical and laboratory confirmed diagnosis of HAE (baseline C1INH activity <50% of
normal)
- Signed written Informed Consent Form (ICF)(parental permission) signed by the legal
guardian(s)
- Clinical symptoms of an acute HAE attack
- Onset of eligible symptoms within 5 hours from the moment at which medical evaluation
to determine eligibility has occurred
- Attack severity moderate or greater, as rated by the investigator
Exclusion Criteria:
- A diagnosis of acquired C1INH deficiency (AAE)
- A medical history of allergy to rabbits or rabbit-derived products or positive
anti-rabbit epithelium (dander) immunoglobuline E (IgE) test
Age minimum:
2 Years
Age maximum:
13 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hereditary Angioedema
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Intervention(s)
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Drug: rhC1INH
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Primary Outcome(s)
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Time to Beginning of Relief Based on Visual Analogue Scale (VAS) Was Defined as the Time, in Minutes, From Time of Infusion to the Beginning of Relief.
[Time Frame: The assessment of the angioedema signs by the VAS and TEQ will be performed just before start of infusion, and at T30m, T1h, T2h, T4h, T8h and T24h after study medication infusion VAS score decrease of = 20 mm from baseline.]
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Secondary Outcome(s)
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Time to Minimal Symptoms Based on Patient's VAS Scores; Time From the Start of the Infusion of Study Medication to the First Assessment Time at Which the Overall Severity VAS Reaches a Value of Less Than 20 mm for All Locations
[Time Frame: The assessment of the angioedema signs by the VAS and TEQ will be performed just before start of infusion, and at T30m, T1h, T2h, T4h, T8h and T24h after study medication infusion all locations where VAS Scores were recorded.]
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Secondary ID(s)
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C1 1209
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2011-000987-92
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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