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NCT01560286 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Subcutaneously Administered rAvPAL-PEG in Patients With Phenylketonuria for 24 Weeks
A Phase 2 study of Phenylketonuria, sponsored by BioMarin Pharmaceutical.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 6
- Study locations
NCT01560286: Completed Phase 2 study of Phenylketonuria, sponsored by BioMarin Pharmaceutical.
NCT01560286 is a Phase 2 study of Phenylketonuria that has completed, run by BioMarin Pharmaceutical. The registered enrollment target is 24 participants, below the 97-participant average among 12 other Phenylketonuria trials with a reported enrollment target (75% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01560286, a Phase 2 study of Phenylketonuria, has completed, sponsored by BioMarin Pharmaceutical.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 6
- Study locations
Study Summary
The primary objective of the study is to evaluate the effect of dosing regimens of multiple subcutaneous (SC) doses of rAvPAL-PEG to induce an early and sustained Phe reduction while decreasing the frequency and severity of hypersensitivity reactions in patients with PKU.
Primary Outcome
All patients will have their plasma Phenylalanine (Phe) assessed. Please note that "Pharmacokinetics Sub-study" was not performed, and thus no results are available.
Conditions Studied
Interventions
- BIOLOGICAL BMN 165 (rAvPAL-PEG)
Study Locations (6)
Colorado
- The Children's Hospital - Aurora
Florida
- University of Florida, Gainesville - Gainesville
Massachusetts
- Children's Hospital Boston - Boston
Nebraska
- Nebraska Medical Center - Omaha
New York
- Albany Medical Center - Albany
Utah
- University of Utah Hospital - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-05 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
What the finished NCT01560286 record still lists
NCT01560286 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 97-participant average among 12 other Phenylketonuria trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Phenylketonuria appearing as the primary indexed condition, and to 1 intervention - of which BMN 165 (rAvPAL-PEG) is the first listed.
NCT01560286 lists 6 locations in 6 states (Colorado, Florida, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT01560286 about?
NCT01560286 is a clinical study titled "A Study to Evaluate Subcutaneously Administered rAvPAL-PEG in Patients With Phenylketonuria for 24 Weeks". The primary objective of the study is to evaluate the effect of dosing regimens of multiple subcutaneous (SC) doses of rAvPAL-PEG to induce an early and sustained Phe reduction while decreasing the frequency and severity of hypersensitivity reactions in patients with PKU.
What is the current status of trial NCT01560286?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2012-05. Estimated completion is 2015-07.
What conditions does trial NCT01560286 study?
This clinical trial studies the following conditions: Phenylketonuria.
What interventions are being tested in trial NCT01560286?
The interventions under investigation include: BMN 165 (rAvPAL-PEG) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01560286?
This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01560286 being conducted?
This trial has 6 study locations across Colorado, Florida, Massachusetts, Nebraska, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Phenylketonuria
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01560286's enrollment target sits among peer trials
24 11th of 12 higher than 2 of 12 other Phenylketonuria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phenylketonuria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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