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NCT01819727 · ClinicalTrials.gov registry record · Phase 3
An Open-Label Phase 3 Study of BMN 165 for Adults With PKU Not Previously Treated w/ BMN 165
A Phase 3 study, sponsored by BioMarin Pharmaceutical.
- Completed
- Registry status
- Phase 3
- Development phase
- 261
- Enrollment target
NCT01819727 is a Phase 3 study that has completed, run by BioMarin Pharmaceutical. The registered enrollment target is 261 participants.
The verdict
NCT01819727, a Phase 3 study, has completed, sponsored by BioMarin Pharmaceutical.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 261 participants
- Enrollment target
Study Summary
The BMN 165 clinical development program has been designed to demonstrate the safety and efficacy of BMN 165 in reducing blood Phe concentrations in patients 18 to 70 years old with hyperphenylalaninemia due to PKU. Study BMN 165-301 is a Phase 3, open-label, randomized study designed to further characterize the safety of BMN 165 during two induction, titration, and maintenance dose regimens in adults with PKU who have not had previous exposure to BMN 165 (naive). Subjects will be randomized (1:1) to titrate up to one of two dose regimens. Other key features of this study are the dose regimens chosen for induction and titration; the study duration; self administration of study drug; and the chosen tertiary objectives.
Interventions
- DRUG BMN 165
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 261 participants |
| Start Date | 2013-05 |
| Est. Completion | 2015-11-25 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01819727
The ClinicalTrials.gov registry entry for NCT01819727 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 261 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 165 is the first listed.
NCT01819727 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01819727 about?
NCT01819727 is a clinical study titled "An Open-Label Phase 3 Study of BMN 165 for Adults With PKU Not Previously Treated w/ BMN 165". The BMN 165 clinical development program has been designed to demonstrate the safety and efficacy of BMN 165 in reducing blood Phe concentrations in patients 18 to 70 years old with hyperphenylalaninemia due to PKU. Study BMN 165-301 is a Phase 3, open-label, randomized study designed to further cha...
What is the current status of trial NCT01819727?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 261 participants. The study started on 2013-05. Estimated completion is 2015-11-25.
What interventions are being tested in trial NCT01819727?
The interventions under investigation include: BMN 165 (DRUG).
Who is sponsoring clinical trial NCT01819727?
This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.
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