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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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EUCTR |
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Last refreshed on:
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16 June 2014 |
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Main ID: |
EUCTR2010-020310-28-AT |
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Date of registration:
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08/11/2010 |
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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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AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS)
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Scientific title:
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AN OPEN-LABEL, MULTI-CENTER CLINICAL TRIAL OF ECULIZUMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC-UREMIC SYNDROME (aHUS) |
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Date of first enrolment:
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16/12/2010 |
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Target sample size:
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15 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020310-28 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Austria
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Belgium
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Germany
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Italy
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Netherlands
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Spain
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Patient’s parent/legal guardian must be willing and able to give written informed
consent and the patient must be willing to give written informed assent [if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees (IRB/IEC)].
2. Pediatric patients with aHUS. Patients may be newly diagnosed, or with previously
diagnosed disease, or post-kidney transplant with the disease.
3. Patients from 1 month up to 18 years of age and body weight = 5 kg.
4. Patient exhibit Thrombocytopenia, hemolysis and elevated Serum Creatinine
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Plasma Therapy for > 5 weeks prior to enrollment.
2. Chronic dialysis
3. Prior eculizumab use or hypersensitivity to eculizumab, to murine proteins or to one of the excipients.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Pediatric patients with Atypical Hemolytic-Uremic Syndrome (aHUS)
MedDRA version: 14.0
Level: LLT
Classification code 10019515
Term: Hemolytic uremic syndrome
System Organ Class: 10005329 - Blood and lymphatic system disorders
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Intervention(s)
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Trade Name: SOLIRIS
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: eculizumab
Current Sponsor code: h5G1.1-mAb
Other descriptive name: Anti-C5 antibody
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
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Primary Outcome(s)
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Secondary Objective: Efficacy
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Main Objective: Assess the efficacy and safety of eculizumab in pediatric patients with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal impairment.
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Primary end point(s): Primary Efficacy Endpoint:
Proportion of patients with complete TMA response.
Primary Safety Endpoint:
Safety assessments.
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Secondary ID(s)
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2010-020310-28-NL
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C10-003
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NCT01193348
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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