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NCT01842607 · ClinicalTrials.gov registry record · Phase 3
A Study to Determine Long-term Safety of Mepolizumab in Asthmatic Subjects
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 651
- Enrollment target
NCT01842607: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01842607 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 651 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01842607, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 651 participants
- Enrollment target
Study Summary
This is a multi-centre, open-label long-term safety study of 100 milligram (mg) mepolizumab administered subcutaneously (SC) every 4 weeks for 12 months in addition to standard of care in subjects who have severe, refractory asthma and a history of eosinophilic inflammation. Subjects who completed either MEA115588 or MEA115575 will be offered the opportunity to consent for this study.
Primary Outcome
AEs were collected from the Baseline visit until the follow-up visit (approx. 12 weeks post-last dose). Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs were defined as events occurring from the first dose until 28 days after the l
Interventions
- BIOLOGICAL Mepolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 651 participants |
| Start Date | 2013-05-27 |
| Est. Completion | 2015-03-13 |
| Phase | Phase 3 |
What the finished NCT01842607 record still lists
NCT01842607 is an interventional study that assigns participants to a tested intervention. The registered 651 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 1 intervention - of which Mepolizumab is the first listed.
NCT01842607 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01842607 about?
NCT01842607 is a clinical study titled "A Study to Determine Long-term Safety of Mepolizumab in Asthmatic Subjects". This is a multi-centre, open-label long-term safety study of 100 milligram (mg) mepolizumab administered subcutaneously (SC) every 4 weeks for 12 months in addition to standard of care in subjects who have severe, refractory asthma and a history of eosinophilic inflammation. Subjects who completed e...
What is the current status of trial NCT01842607?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 651 participants. The study started on 2013-05-27. Estimated completion is 2015-03-13.
What interventions are being tested in trial NCT01842607?
The interventions under investigation include: Mepolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01842607?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01842607's enrollment target sits among peer trials
651 572nd of 2000 higher than 1,429 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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