A Study to Evaluate Subcutaneously Administered rAvPAL-PEG in Patients With Phenylketonuria for 24 Weeks
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01560286 |
Recruitment Status :
Completed
First Posted : March 22, 2012
Results First Posted : February 27, 2019
Last Update Posted : August 6, 2019
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Sponsor:
BioMarin Pharmaceutical
Information provided by (Responsible Party):
BioMarin Pharmaceutical
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Phenylketonuria |
Intervention |
Biological: BMN 165 (rAvPAL-PEG) |
Enrollment | 24 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | BMN 165 (rAvPAL-PEG) |
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[Not Specified] |
Period Title: Overall Study | |
Started | 24 |
Completed | 24 |
Not Completed | 0 |
Baseline Characteristics
Arm/Group Title | rAvPAL-PEG | |
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All 24 Enrolled Subjects | |
Overall Number of Baseline Participants | 24 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 24 participants | |
29.3 (11.43) | ||
Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 24 participants |
< 18 years |
1 4.2%
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> or = 18 years |
23 95.8%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 24 participants | |
Female |
13 54.2%
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Male |
11 45.8%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 24 participants | |
Hispanic or Latino |
0 0.0%
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Not Hispanic or Latino |
24 100.0%
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Unknown or Not Reported |
0 0.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 24 participants |
American Indian or Alaska Native |
0 0.0%
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Asian |
0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
0 0.0%
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White |
24 100.0%
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Other |
0 0.0%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 24 participants |
24 100.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Sr. Medical Director, Clinical Science |
Organization: | BioMarin Pharmaceutical Inc |
Phone: | 415-475-5854 |
EMail: | Ari.Gershman@bmrn.com |
Responsible Party: | BioMarin Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT01560286 |
Other Study ID Numbers: |
165-205 |
First Submitted: | March 5, 2012 |
First Posted: | March 22, 2012 |
Results First Submitted: | June 22, 2018 |
Results First Posted: | February 27, 2019 |
Last Update Posted: | August 6, 2019 |