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NCT01366521 · ClinicalTrials.gov registry record · Phase 2
Dose Ranging Pharmacokinetics and Pharmacodynamics Study With Mepolizumab in Asthma Patients With Elevated Eosinophils
A Phase 2 study of Asthma, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 11
- Study locations
NCT01366521 is a Phase 2 study of Asthma that has completed, run by GlaxoSmithKline. The registered enrollment target is 70 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (96% lower). The trial reports 11 study locations across 7 states.
The verdict
NCT01366521, a Phase 2 study of Asthma, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 11
- Study locations
Study Summary
A multi-center, randomized, open-label, parallel-group, repeat dose study in asthma patients with elevated eosinophils. Eligible subjects will receive 3 doses (28 days apart) of mepolizumab given intravenous (IV) or subcutaneously (SC). Blood samples for safety, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity analysis, as well as safety/tolerability assessments will be collected throughout the study
Conditions Studied
Interventions
- BIOLOGICAL Mepolizumab
Study Locations (11)
Other
- GSK Investigational Site - Tallinn
- GSK Investigational Site - Tartu
- GSK Investigational Site - Marseille
- GSK Investigational Site - Montpellier
- GSK Investigational Site - Pessac
North Carolina
- GSK Investigational Site - Winston-Salem
Pennsylvania
- GSK Investigational Site - Pittsburgh
Bavaria
- GSK Investigational Site - Gauting
Hesse
- GSK Investigational Site - Frankfurt am Main
Saxony-Anhalt
- GSK Investigational Site - Magdeburg
State of Berlin
- GSK Investigational Site - Berlin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2011-02 |
| Est. Completion | 2012-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01366521
The ClinicalTrials.gov registry entry for NCT01366521 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (96% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 1 intervention - of which Mepolizumab is the first listed.
NCT01366521 reports 11 study locations spanning 7 distinct geographic areas - top geographies include Other, North Carolina, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01366521 about?
NCT01366521 is a clinical study titled "Dose Ranging Pharmacokinetics and Pharmacodynamics Study With Mepolizumab in Asthma Patients With Elevated Eosinophils". A multi-center, randomized, open-label, parallel-group, repeat dose study in asthma patients with elevated eosinophils. Eligible subjects will receive 3 doses (28 days apart) of mepolizumab given intravenous (IV) or subcutaneously (SC). Blood samples for safety, pharmacokinetics (PK), pharmacodynami...
What is the current status of trial NCT01366521?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2011-02. Estimated completion is 2012-03.
What conditions does trial NCT01366521 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT01366521?
The interventions under investigation include: Mepolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01366521?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01366521 being conducted?
This trial has 11 study locations across North Carolina, Pennsylvania, Bavaria, Hesse, Saxony-Anhalt. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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