EUCTR2007-000838-39-PL
Active, not recruiting
Phase 1
Expanded access program for mepolizumab in subjects with HES
ConditionsHypereosinophilic syndrome (HES)MedDRA version: 20.0Level: PTClassification code 10048643Term: Hypereosinophilic syndromeSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
DrugsNucala
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hypereosinophilic syndrome (HES)
- Sponsor
- GlaxoSmithKline Research & Development Ltd
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. In accordance with local procedures, written informed consent/assent can be obtained from the subject or legally authorized representative
- •2\. \= 12 years of age at the time of signing the informed consent/assent
- •3\. Meets the diagnostic criteria for HES as defined by:
- •\- Eosinophilia \>1500 cells/µl for at least 6 months with evidence of symptoms and
- •signs of organ system involvement or dysfunction that can be directly related to
- •eosinophilia (with no evidence of parasitic, allergic or other recognised causes of
- •eosinophilia such as connective tissues disease, malignancy)
- •\- Eosinophilia of \>1500 cells/µl for less than 6 months and meet the other criteria
- •for HES accompanied by clear evidence of eosinophil tissue infiltration and with
- •exclusion of secondary causes of eosinophilia as above.
Exclusion Criteria
- •1\. Subjects without HES but with other conditions associated with eosinophilic
- •pathological processes such as Eosinophilic Granulomatosis with Polyangiitis
- •\[EGPA], Wegener’s Granulomatosis, atopic disorders, parasitic infections,
- •eosinophilic gastroenteropathies.
- •2\. Female subjects of childbearing potential who are not using a highly effective
- •method of contraception:
- •Consistent and correct use of an acceptable method of birth control for one month
- •prior to the start of the investigational product and until 16 weeks after the last
- •dose (see Section 12\.2 of the protocol for a list of acceptable methods of contraception).
- •3\. Pregnant or lactating females
Outcomes
Primary Outcomes
Not specified
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