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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: Completed Phase 3 study of Phenylketonuria (PKU), sponsored by BioMarin Pharmaceutical.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Blood phe concentration in subjects previously exposed to BMN165 who were administered BMN165 20 or 40 mg/day compared with those who were administered a matching placebo.
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 |
What the finished NCT01889862 record still lists
NCT01889862 is an interventional study that assigns participants to a tested intervention. The registered 215 participants enrollment target is mid-sized for trials with a published cap, above the 146-participant average among 6 other Phenylketonuria (PKU) trials with a reported enrollment target (47% higher).
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 names 20 study sites across 14 states, led by 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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