Phase 3 Study to Evaluate the Efficacy & Safety of Self-Administered Injections of BMN165 by Adults With PKU
Public ClinicalTrials.gov record NCT01889862. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Four-Part, Phase 3, Randomized, Double-Blind, Placebo- Controlled, Four-Arm, Discontinuation Study to Evaluate the Efficacy and Safety of Subcutaneous Injections of BMN 165 Self-Administered by Adults With Phenylketonuria (PKU)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01889862
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 215 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 29, 2013 (Actual)
- Primary completion
- Jan 13, 2016 (Actual)
- Completion
- Feb 5, 2019 (Actual)
- Last update posted
- May 21, 2021
2013 – 2019
United States locations
- U.S. sites
- 29
- U.S. states
- 22
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, San Diego Clinical and Translational Research Institute | La Jolla | California | 92093 | — |
| UCSF Benioff Children's Hospital Oakland | Oakland | California | 94609 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| University of Florida Clinical Research Center | Gainesville | Florida | 32610 | — |
| University of South Florida | Tampa | Florida | 33606 | — |
| Emory Universty, Department of Human Genetics, Division of Medical Genetics | Atlanta | Georgia | 30322 | — |
| Ann and Robert H Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| Indiana CTSI Clinical Research Center | Indianapolis | Indiana | 46202 | — |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | — |
| University of Louisville, Kosair Charities Pediatric Clinical Research Unit | Louisville | Kentucky | 40202 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| Wayne State University Clinical Research Center at the Mott Center | Detroit | Michigan | 48202 | — |
| University of Missouri Health Center | Columbia | Missouri | 65212 | — |
| Washington University Center for Applied Research Sciences | St Louis | Missouri | 63110 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Cooper Health Systems | Camden | New Jersey | 08103 | — |
| Atlantic Health System - Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| Albany Medical Center | Albany | New York | 12208 | — |
| Icahn School of Medicine at Mount Sinai Medical Center | New York | New York | 10029 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | — |
| Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15224 | — |
| Vanderbilt Children's Hospital | Nashville | Tennessee | 37232 | — |
| University of Texas Houston Medical School | Houston | Texas | 77030 | — |
| University of Utah Hospital | Salt Lake City | Utah | 84108 | — |
| University of Washinton | Seattle | Washington | 98195 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01889862, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 21, 2021 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01889862 live on ClinicalTrials.gov.