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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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25 November 2019 |
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Main ID: |
EUCTR2005-006074-10-GB |
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Date of registration:
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07/02/2006 |
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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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A randomized, double-blind, parallel group clinical trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab (SB240563) (0.55mg/kg, 2.5mg/kg or 10mg/kg) in pediatric subjects with eosinophilic esophagitis, aged 2 to 17 years - Mepolizumab in paediatric eosinophilic oesophagitis
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Scientific title:
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A randomized, double-blind, parallel group clinical trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab (SB240563) (0.55mg/kg, 2.5mg/kg or 10mg/kg) in pediatric subjects with eosinophilic esophagitis, aged 2 to 17 years - Mepolizumab in paediatric eosinophilic oesophagitis |
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Date of first enrolment:
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15/06/2006 |
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Target sample size:
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72 |
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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:2005-006074-10 |
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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: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
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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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. The subject signs a written assent form and the parent/guardian signs a written informed consent form prior to the initiation of any study-related activities.
2. Male or female subjects aged 2 to 17 years who speak, read and write English as age appropriate and/or parent guardian
3. To be eligible for entry in the treatment group of the study, a female must be
a. Not pregnant or nursing
b. Of non-childbearing potential ie a pre-menarcheal female who has not yet entered puberty as evidenced by lack of breast development or who has had a hysterectomy and/or bilateral oophorectomy.
c. If of childbearing potential, subjects must have a negative urine pregnancy test at the screening visit, and agree to use of an acceptable method of contraception from at least the commencement of their last period prior to the first dose of study medication and to continue until the first period after treatment or after the Week 24 Follow-up visit, whichever is longest
4. The subject has isolated eosinophilic oesophagitis defined as:
• Peak esophageal eosinophil counts (highest count of eosinophils per HPF in at least one of all esophageal sites biopsied) of 20 or more eosinophils in a minimum of one HPF at 400X magnification on histology of oesophageal biopsies from distal and mid-oesophagus within 2 weeks of commencing study medication.
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• Inadequate response to or intolerant of therapy for eosinophilic oesophagitis
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. Current evidence of eosinophilic gastrointestinal enteropathy (EGID), other than eosinophilic oesophagitis
2. Current, or suspected evidence of gastroesophageal reflux disease, or other causes of oesophagitis.
3. Current evidence, or history of (anytime in the past):
a. hypereosinophilic syndromes,
b. allergic gastroenteritis,
c. bacterial infections*,
d. parasitic infestations*,
e. collagen vascular disease,
f. vasculitis,
g. allergic drug reaction,
h. graft-versus host disease.
i. chronic idiopathic inflammatory bowel disorders (ulcerative colitis, Crohn's disease, chronic granulomatous disease)
*If the subject has a past history of bacterial or parasite infection/infestation, the investigator must ensure that the bacterial or parasite infaction/infestation was adequately treated and/or that there is no current bacterial or parasite infection/infestation.
4. Current evidence, or history of celiac disease
5. Current evidence of active H. pylori infection.
6. Abnormal 12-lead ECG at Screening which is clinically significant. Note that this exclusion criteria does not apply for subject who are considered for enrolment in the observational cohort
7. Use or administration of any of the prohibited medications listed in Section 9.2 of the protocol from Screening and throughout completion of Week 34 follow-up assessments or immunisation from 6 weeks prior to Screening through the Week 24 visit. Note that this exclusion criteria does not apply for subject who are considered for enrolment in the observational cohort
8. Failure to remain on a stable dose of one (or more) permitted medication(s) for at least 1 month prior to the Screening visit and throughout completion of Week 34 follow-up assessments. Note that this exclusion criteria does not apply for subject who are considered for enrolment in the observational cohort
9. Failure to remain on stable elemental diet or dietary manipulations for at least 3 months prior to the Screening Visit and throughout completion of Week 34 follow-up assessments. Note that this exclusion criteria does not apply for subject who are considered for enrolment in the observational cohort
10. Known history of allergic reaction to previous antibody therapy.
11. Any previous treatment with anti-hIL-5, anti-IgE monoclonal antibody or other biological agents.
12. Use of an investigational drug within 30 days of entering the study. Note that this exclusion criteria does not apply for subject who are considered for enrolment in the observational cohort
13. Evidence of renal disease or serum creatinine > 1.5 times upper limit of normal range (ULN). Note that this exclusion criteria does not apply for subject who are considered for enrolment in the observational cohort
14. Evidence of hepatic disease, impairment or abnormal liver function test i.e. AST, ALT >1.5 times ULN , bilirubin >1.5 times ULN. Note that this exclusion criteria does not apply for subject who are considered for enrolment in the observational cohort
15. Current evidence of HIV, Hepatitis B or C infection.
16. History or suspicion of cu
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Eosinophilic oesophagitis
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Intervention(s)
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Product Name: Mepolizumab
Product Code: SB-240563
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Mepolizumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
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Primary Outcome(s)
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Main Objective: To investigate in paediatric subjects with eosinophilic oesophagitis
1. safety and tolerability of iv mepolizumab (0.55mg/kg, 2.5mg/kg or 10mg/kg),
2. pharmacokinetics of iv mepolizumab (0.55mg/kg, 2.5mg/kg or 10mg/kg),
3. the capacity of iv mepolizumab (0.55mg/kg, 2.5mg/kg or 10mg/kg) to reduce oesophageal eosinophil counts to within normal limits (highest count of eosinophils per HPF of all oesophageal sites biopsied to lower than 5 cells per HPF at X400 magnification)
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Secondary Objective: 1. To obtain dose-response information for design of subsequent studies.
2. To explore the relationship between dose and clinical response:
• Frequency and severity of the cardinal symptoms at Week 12 and Week 24:
a. oeosinophilic esophagitis-related pain,
b. regurgitation,
c. vomiting
d. swallowing disorders,
e. feeding difficulties,
• Time to relapse in subjects who responded at Week 12 as defined by histopathology confirmation with peak eosinophil count (highest count of eosinophils per HPF of all esophageal sites biopsied) of 20 or more eosinophils per HPF at 400 X magnification in esophageal biopsy specimens.
3. To investigate the relationship between pharmacodynamic parameters (e.g. counts of circulating eosinophils, histopathology parameters) and pharmacokinetics.
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Primary end point(s): 1. Safety and tolerability endpoints will be assessed separately for the treatment (up to Week 12) and the follow-up phase Week 13-24)
• Adverse Events: frequency, severity and relationship to study medication
• Changes in laboratory values (including biochemistry, hematology including eosinophil counts (absolute values and percentage of total white blood cells), and urinalysis
• Changes in vital signs
• Changes in 12-lead ECG.
• Levels of anti-mepolizumab antibodies
2. Pharmacokinetics endpoints
• Pharmacokinetic parameters such as V and CL of mepolizumab will be obtained.
3. Histopathology primary endpoint
• Proportion of subjects who achieve a reduction in peak eosinophil counts (highest count of eosinophils per HPF in all esophageal sites biopsied) to lower than 5 eosinophils per HPF at 400X magnification, in esophageal biopsy specimens taken at Week 12.
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Secondary ID(s)
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MEE103219
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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