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NCT00097370 · ClinicalTrials.gov registry record · Phase 3
Open-Label Extension Of Intravenous Mepolizumab In Patients With Hypereosinophilic Syndrome
A Phase 3 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 3
- Development phase
- 78
- Enrollment target
NCT00097370: Clinical Trial Phase 3 study, sponsored by GlaxoSmithKline.
NCT00097370 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 78 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00097370, a Phase 3 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 78 participants
- Enrollment target
Study Summary
This is an open label study of mepolizumab 750 mg intravenous in those subjects who participated in study 100185 to evaluate the long term safety and efficacy of mepolizumab in subjects with hypereosinophilic syndrome. The study will also evaluate the optimal dosing frequency for clinical use, the effects on corticosteroid reduction, and decrease of signs and symptoms of Hypereosinophilic Syndrome.
Primary Outcome
An AE is any untoward medical occurrence in clinical investigation participants temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs are summarized by Treatment phase. Safety and tolerability of the study drug was assessed by number of participants with any AE
Interventions
- DRUG mepolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2004-09-30 |
| Est. Completion | 2010-09-29 |
| Phase | Phase 3 |
Why NCT00097370 stopped before completion
NCT00097370 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which mepolizumab is the first listed.
NCT00097370 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00097370 about?
NCT00097370 is a clinical study titled "Open-Label Extension Of Intravenous Mepolizumab In Patients With Hypereosinophilic Syndrome". This is an open label study of mepolizumab 750 mg intravenous in those subjects who participated in study 100185 to evaluate the long term safety and efficacy of mepolizumab in subjects with hypereosinophilic syndrome. The study will also evaluate the optimal dosing frequency for clinical use, the e...
What is the current status of trial NCT00097370?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 78 participants. The study started on 2004-09-30. Estimated completion is 2010-09-29.
What interventions are being tested in trial NCT00097370?
The interventions under investigation include: mepolizumab (DRUG).
Who is sponsoring clinical trial NCT00097370?
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 NCT00097370's enrollment target sits among peer trials
78 1769th of 2000 higher than 230 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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