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NCT01691859 · ClinicalTrials.gov registry record · Phase 3
MEA112997 Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 347
- Enrollment target
NCT01691859: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01691859 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 347 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01691859, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 347 participants
- Enrollment target
Study Summary
This is a multi-centre, open-label long term safety study of 100 milligrams (mg) mepolizumab administered subcutaneously (SC) in addition to standard of care in subjects who participated in the MEA112997 study. At each clinic visit, adverse events will be assessed and exacerbations will also be reviewed.
Primary Outcome
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a medicinal product (MP), whether or not considered related to MP. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with use of MP. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or pr
Interventions
- DRUG Mepolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 347 participants |
| Start Date | 2012-09-28 |
| Est. Completion | 2017-05-31 |
| Phase | Phase 3 |
What the finished NCT01691859 record still lists
NCT01691859 is an interventional study that assigns participants to a tested intervention. The registered 347 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 (55% lower).
The record links to 0 conditions, and to 1 intervention - of which Mepolizumab is the first listed.
NCT01691859 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01691859 about?
NCT01691859 is a clinical study titled "MEA112997 Open-label Long Term Extension Safety Study of Mepolizumab in Asthmatic Subjects". This is a multi-centre, open-label long term safety study of 100 milligrams (mg) mepolizumab administered subcutaneously (SC) in addition to standard of care in subjects who participated in the MEA112997 study. At each clinic visit, adverse events will be assessed and exacerbations will also be revi...
What is the current status of trial NCT01691859?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 347 participants. The study started on 2012-09-28. Estimated completion is 2017-05-31.
What interventions are being tested in trial NCT01691859?
The interventions under investigation include: Mepolizumab (DRUG).
Who is sponsoring clinical trial NCT01691859?
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 NCT01691859's enrollment target sits among peer trials
347 1048th of 2000 higher than 952 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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