Status:
COMPLETED
Evaluation of PKU Sphere in Italy
Lead Sponsor:
Vitaflo International, Ltd
Conditions:
Phenylketonurias
PKU
Eligibility:
All Genders
3+ years
Phase:
NA
Brief Summary
20 participants with PKU will build-up their dietary intake of PKU sphere over 2-16 weeks, depending on their level of metabolic control whilst doing so. Participants will complete a gastrointestinal ...
Detailed Description
20 participants with phenylketonuria (PKU) will introduce PKU sphere into their diet. PKU sphere is a food for special medical purposes (as defined by Regulation (EU) No 609/2013 on food for specific ...
Eligibility Criteria
Inclusion
- Patients diagnosed with PKU or hyperphenylalaninemia via new born screening and early treated, requiring \>50% of protein intake from protein substitute.
- Aged 3 years and above.
- Female patients of childbearing potential must have a negative urine pregnancy test prior to completing the screening procedures.
- Willingly given, written, informed consent from the participant, 18 or more years, or from the parent/guardian for participants \< 18 years.
- Willingly given, written assent (if appropriate) for those \< 18 years.
Exclusion
- Pregnant, planning pregnancy or breastfeeding.
- Intake of sapropterin dihydrochloride (Kuvan), PEG PAL or large neutral amino acids within 30 days prior to screening visit.
- Patients currently taking their maximum recommended amount of protein substitute from a GMP based protein substitute.
- Patients who are unable/unwilling to replace their current GMP protein substitute (if any) with PKU sphere.
- Patients with known soya, milk or fish allergies / intolerance.
- Individuals, who in the opinion of the investigator, are unable to comply with the requirements of the protocol.
- Any co-morbidity, which in the opinion of the Investigator, would preclude participation in the study.
- Patients who are currently participating in, plan to participate in, or have participated in an interventional investigational drug, food or medical device trial within 30 days prior to screening visit.
Key Trial Info
Start Date :
January 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04679467
Start Date
January 15 2020
End Date
July 31 2022
Last Update
February 16 2024
Active Locations (4)
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1
Sant'Orsola-Malpighi Polyclinic (adults)
Bologna, Italy
2
Sant'Orsola-Malpighi Polyclinic (paediatrics)
Bologna, Italy
3
Ospedale San Paolo
Milan, Italy
4
A.O.R.N. Santobono-Pausilipon - Ospedale Santobono
Napoli, Italy