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NCT01889862 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study to Evaluate the Efficacy & Safety of Self-Administered Injections of BMN165 by Adults With PKU
A Phase 3 study of Phenylketonuria (PKU), sponsored by BioMarin Pharmaceutical.
- Completed
- Registry status
- Phase 3
- Development phase
- 215
- Enrollment target
- 20
- Study locations
NCT01889862 is a Phase 3 study of Phenylketonuria (PKU) that has completed, run by BioMarin Pharmaceutical. The registered enrollment target is 215 participants, above the 146-participant average among 6 other Phenylketonuria (PKU) trials with a reported enrollment target (47% higher). The trial reports 20 study locations across 14 states.
The verdict
NCT01889862, a Phase 3 study of Phenylketonuria (PKU), has completed, sponsored by BioMarin Pharmaceutical.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 215 participants
- Enrollment target
- 20
- Study locations
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 adults with PKU.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BMN165 20mg/day
- DRUG BMN165 40mg/day
Study Locations (20)
California
- University of California, San Diego Clinical and Translational Research Institute - La Jolla
- UCSF Benioff Children's Hospital Oakland - Oakland
Florida
- University of Florida Clinical Research Center - Gainesville
- University of South Florida - Tampa
Kentucky
- University of Kentucky Medical Center - Lexington
- University of Louisville, Kosair Charities Pediatric Clinical Research Unit - Louisville
Missouri
- University of Missouri Health Center - Columbia
- Washington University Center for Applied Research Sciences - St Louis
New Jersey
- Cooper Health Systems - Camden
- Atlantic Health System - Morristown Medical Center - Morristown
New York
- Albany Medical Center - Albany
- Icahn School of Medicine at Mount Sinai Medical Center - New York
Colorado
- Children's Hospital Colorado - Aurora
Georgia
- Emory Universty, Department of Human Genetics, Division of Medical Genetics - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2013-07-29 |
| Est. Completion | 2019-02-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01889862
The ClinicalTrials.gov registry entry for NCT01889862 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 215 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 146-participant average among 6 other Phenylketonuria (PKU) trials with a reported enrollment target (47% higher). The listed sponsor is BioMarin Pharmaceutical, which has 80 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Phenylketonuria (PKU) appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01889862 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Florida, Kentucky.
Frequently Asked Questions
What is clinical trial NCT01889862 about?
NCT01889862 is a clinical study titled "Phase 3 Study to Evaluate the Efficacy & Safety of Self-Administered Injections of BMN165 by Adults With PKU". The BMN 165 clinical development program has been designed to demonstrate the safety and efficacy of BMN 165 in reducing blood Phe concentrations in adults with PKU.
What is the current status of trial NCT01889862?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 215 participants. The study started on 2013-07-29. Estimated completion is 2019-02-05.
What conditions does trial NCT01889862 study?
This clinical trial studies the following conditions: Phenylketonuria (PKU).
What interventions are being tested in trial NCT01889862?
The interventions under investigation include: Placebo (DRUG), BMN165 20mg/day (DRUG), BMN165 40mg/day (DRUG).
Who is sponsoring clinical trial NCT01889862?
This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01889862 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. 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
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.