201956: A Long-term Access Programme for Subjects with Severe Asthma who Participated in a GSK-sponsored Mepolizumab Clinical Study
- Conditions
- severe asthma10006436
- Registration Number
- NL-OMON43801
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
• Participated in GSK-sponsored asthma clinical study with mepolizumab as specified in the protocol, appendix 2.
• either:
1. completed the treatment period in the mepolizumab asthma clinical study to which they were originally enrolled
or
2. if the subject was withdrawn from study treatment prematurely during the mepolizumab asthma clinical study to which they were originally enrolled but the subject has completed the study assessments at the study visit that would have been the end of the respective treatment period.
• The treating physician considers the benefits of treatment with mepolizumab outweigh the risks for the individual subject.
• Adequate contraception for females of childbearing potential.
• 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.
• Treatment with another biological therapy.
• Treatment with an investigational drug within the past 30 days or 5 terminal phase half-lives.
• Current participation in any other interventional clinical study.
• Pregnancy or breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>NA</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>