Status:
COMPLETED
Market Research - Acceptability Study for a New PKU Protein Substitute
Lead Sponsor:
Dr. Schär AG / SPA
Conditions:
PKU
Phenylketonurias
Eligibility:
All Genders
3-16 years
Phase:
NA
Brief Summary
The aim of this study is to demonstrate that a new protein substitute is acceptable and well tolerated in children with PKU.
Eligibility Criteria
Inclusion
- Diagnosis of PKU or PKU variant requiring a protein substitute.
- Subjects who were already taking a phenylalanine-free/low phenylalanine protein substitute and were willing to try the study product for 7 days.
- Patients aged 3 years of age to adulthood.
- Written informed consent obtained from participant or parental caregiver (as appropriate).
Exclusion
- Presence of serious concurrent illness
- Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
- Any patients having taken antibiotics over the previous 2 weeks leading up to the study.
- Patients less than 3 years of age.
Key Trial Info
Start Date :
February 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04318509
Start Date
February 4 2019
End Date
May 19 2019
Last Update
March 24 2020
Active Locations (2)
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1
Birmingham Children's Hospital
Birmingham, United Kingdom, B4 6NH
2
Bristol Royal Hospital for Children
Bristol, United Kingdom, BS2 8BJ