EUCTR2015-001152-29-CZActive, not recruitingPhase 1
A Long-term Access Programme for Subjects with Severe Asthma who Participated in a GSK-sponsored Mepolizumab Clinical Study
GlaxoSmithKline Research & Development Ltd0 sites550 target enrollmentStarted: August 25, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 550
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •A subject will be eligible for the LAP only if all of the following criteria apply:
- •[1] CLINICAL STUDY PARTICIPATION
- •Subject participated in GSK-sponsored asthma clinical study with mepolizumab as specified in Appendix 2 of the study protocol
- •[2] STUDY COMPLETION
- •2. Subject has either:
- •i. completed the preceding mepolizumab asthma clinical study
- •ii. the subject was withdrawn from study treatment prematurely during the preceding mepolizumab asthma clinical study due to study closure prior to commercial availability
- •[3] PHYSICIAN ASSESSMENT SUPPORTS MEPOLIZUMAB TREATMENT
- •3. The treating physician requesting mepolizumab under this Long-term Access Programme considers the benefits of treatment with mepolizumab outweigh the risks for the individual subject.
- •[4] FEMALE SUBJECTS
- •4. To be eligible for mepolizumab treatment under this Long-term Access Programme, females of childbearing potential (FCBP) must commit to consistent and correct use of an acceptable method of birth control, as summarised in Appendix 4 of the study protocol, beginning with consent, for the duration of the treatment with mepolizumab and for 4 months after the last mepolizumab administration.
- •[5] INFORMED CONSENT
- •5. The subject consents to receiving treatment with mepolizumab under this Long-term Access Programme.
- •Or for paediatrics: parent(s)/guardian able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. If applicable, the subject must be able and willing to give assent to take part in the study according to the local requirement.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 340
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
Exclusion Criteria
- •A subject will not be eligible for the LAP if any of the following criteria apply:
- •[1] MALIGNANCY
- •1. A current malignancy or history of cancer in remission for less than 12 months (Subjects who had localized carcinoma (i.e., basal or squamous cell) of the skin which was resected for cure will not be excluded).
- •[2] OTHER CLINICALLY SIGNIFICANT MEDICAL CONDITIONS
- •2. Subject has other clinically significant medical conditions uncontrolled with standard of-care therapy not associated with asthma, e.g., unstable liver disease, uncontrolled cardiovascular disease, ongoing active infectious disease requiring systemic treatment.
- •[3] PREGNANCY
- •3. Subject is pregnant or breastfeeding. Subjects should not be considered for continued treatment if they plan to become pregnant during the course of treatment with mepolizumab.
- •[4] HYPERSENSITIVITY
- •4. Subject has a known allergy or intolerance to a monoclonal antibody or biologic therapy including mepolizumab.
- •[5] PREMATURE WITHDRAWAL OF STUDY TREATMENT
- •5. Subject had an adverse event (serious or non-serious) considered related to study treatment whilst participating in a clinical study with mepolizumab which resulted in permanent withdrawal of study treatment.
- •[6] OTHER BIOLOGICAL THERAPY
- •6. Subject is receiving treatment with another biological therapy such as a monoclonal antibody therapy or intravenous (IV) immunoglobulin (Ig) therapy.
- •[7] OTHER INVESTIGATIONAL PRODUCTS
- •7. Subjects who have received treatment with an investigational drug within the past 30 days or 5 terminal phase half-lives of the drug whichever is longer, prior to initiation of mepolizumab treatment under this Long-term Access Programme (this also includes investigational formulations of marketed products).
- •[8] OTHER CLINICAL STUDY
- •8. Subject is currently participating in any other interventional clinical study.
Investigators
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