Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01560286
The ClinicalTrials.gov registry entry for NCT01560286 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 97-participant average among 12 other Phenylketonuria trials with a reported enrollment target (75% lower). The listed sponsor is BioMarin Pharmaceutical, which has 80 total studies on file at ClinicalTrials.gov.
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 reports 6 study locations spanning 6 distinct geographic areas - top geographies include 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.
-
A Study to Evaluate the Safety and Efficacy of JNT-517 in Participants With Phenylketonuria (PKU)
RECRUITING · Phase 3
-
Educational, Social Support, and Nutritional Interventions and Their Cumulative Effect on Pregnancy Outcomes and Quality of Life in Teen and Adult Women With Phenylketonuria
RECRUITING · NA
-
A Study of Sepiapterin in Participants With Phenylketonuria (PKU)
RECRUITING · Phase 3
-
Rapid Drug Desensitization Study in Adults Experiencing Hypersensitivity Reactions to Palynziq
RECRUITING · Phase 4
-
A Phase 1/Phase 2 Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of a Single Intravenous Administration of SAR444836 in Adult Participants With Phenylketonuria
ACTIVE NOT RECRUITING · Phase 1
-
First-in-Human, Multiple Part Clinical Study of JNT-517 in Healthy Participants and in Participants With Phenylketonuria
ACTIVE NOT RECRUITING · Phase 1
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.