A Study to Evaluate Subcutaneously Administered rAvPAL-PEG in Patients With Phenylketonuria for 24 Weeks

ClinicalTrials.gov ID: NCT01560286

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Official title

A Phase II, Multi-center, Open-label, Dose-finding Study to Evaluate Safety, Efficacy and Tolerability of Subcutaneously (SC) Administered rAvPAL-PEG in Patients With PKU for 24 Weeks

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT01560286
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: BioMarin Pharmaceutical; Industry
Enrollment: 24 participants

Conditions and interventions

Conditions

Phenylketonuria

Interventions

BMN 165 (rAvPAL-PEG) Biological

Biological

Eligibility (public fields only)

Age range: 16 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: May 2012 (Type not available)
Primary completion: Sep 2013 (Actual)
Completion: Jul 2015 (Actual)
Last update posted: Aug 6, 2019

2012 – 2015

United States locations

U.S. sites: 6
U.S. states: 6
U.S. cities: 6

Facility	City	State	ZIP	Site status
The Children's Hospital	Aurora	Colorado	80048	—
University of Florida, Gainesville	Gainesville	Florida	32610	—
Children's Hospital Boston	Boston	Massachusetts	02115	—
Nebraska Medical Center	Omaha	Nebraska	68198	—
Albany Medical Center	Albany	New York	12208	—
University of Utah Hospital	Salt Lake City	Utah	84132	—

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 NCT01560286, 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 Aug 6, 2019 · Synced Nov 15, 2026