NCT03505125
Phenylketonuria, Phenylketonuria (PKU)
The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. and has not been edited.
The 165-901 study is designed to identify the appropriate tools for use in future interventional studies on the neurocognitive effects of pegvaliase on adults with PKU.
All
18 Years to 70 Years
No
Observational
63
2018-03-31
2020-01-14
Gainesville, Florida, United States
Decatur, Georgia, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Vancouver, British Columbia, Canada
Paris, Cedex 15, France
Tours, Cedex 9, France
Jena, Thuringia, Germany
Leipzig, , Germany
Padova, , Italy
Roma, , Italy
Ankara, , Turkey
İzmir, , Turkey
London, England, United Kingdom
Patients eligible to participate in this study must meet all of the following criteria:
1. ≥18 and ≤70 years of age at the time of consent;
2. Clinically-confirmed diagnosis of Phenylketonuria (PKU);
3. Blood Phe test completed within eight weeks prior to screening date or blood Phe test completed within eight weeks post screening date;
4. Able to read, understand, and speak fluently the language(s) of their designated country sufficiently to participate in an interview and/or complete all assessments;
5. Willing and able to participate in a telephone interview lasting approximately 90 minutes;
6. Willing to be audio-recorded during the interview session;
7. Willing and able to provide written informed consent indicating that they understand the purpose and procedures required for the study and are willing to participate.
Patients meeting any of the following criteria will not be included in the study:
1. Currently pregnant;
2. Current or previous exposure to pegvaliase treatment or participation in a pegvaliase clinical trial;
3. Has a significant cognitive impairment, hearing difficulty, visual impairment, acute psychopathology, medical condition, or insufficient knowledge of the interview language that, in the opinion of the investigator or interviewer, would interfere with his or her ability to provide written consent and participate/complete an interview
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