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NCT01924845 · ClinicalTrials.gov registry record · Phase 3
BMN 701 Phase 3 in rhGAA Exposed Subjects With Late Onset Pompe Disease (INSPIRE Study)
A Phase 3 study, sponsored by BioMarin Pharmaceutical.
- Terminated
- Registry status
- Phase 3
- Development phase
- 24
- Enrollment target
NCT01924845 is a Phase 3 study that was terminated before completion, run by BioMarin Pharmaceutical. The registered enrollment target is 24 participants.
The verdict
NCT01924845, a Phase 3 study, was terminated before completion, sponsored by BioMarin Pharmaceutical.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 24 participants
- Enrollment target
Study Summary
Study 701-301 is a single-arm, open-label, switchover study in patients with late-onset Pompe disease who have been receiving treatment with recombinant human acid alpha-glucosidase (rhGAA) for 48 weeks or longer. Ambulatory patients who have mild to moderate respiratory impairment will switch directly to receive BMN 701 20 mg/kg by IV infusion every other week. All participants will receive active drug. No dose of existing therapy will be missed - experimental drug is started immediately.
Interventions
- DRUG BMN 701
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2014-04 |
| Est. Completion | 2016-09-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01924845
The ClinicalTrials.gov registry entry for NCT01924845 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioMarin Pharmaceutical, which has 80 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BMN 701 is the first listed.
NCT01924845 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01924845 about?
NCT01924845 is a clinical study titled "BMN 701 Phase 3 in rhGAA Exposed Subjects With Late Onset Pompe Disease (INSPIRE Study)". Study 701-301 is a single-arm, open-label, switchover study in patients with late-onset Pompe disease who have been receiving treatment with recombinant human acid alpha-glucosidase (rhGAA) for 48 weeks or longer. Ambulatory patients who have mild to moderate respiratory impairment will switch direc...
What is the current status of trial NCT01924845?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2014-04. Estimated completion is 2016-09-12.
What interventions are being tested in trial NCT01924845?
The interventions under investigation include: BMN 701 (DRUG).
Who is sponsoring clinical trial NCT01924845?
This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.
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