Evaluation of TYR Sphere in France

Not Applicable

Active, not recruiting

• Conditions: Tyrosinemia; AKU

• Registration Number: NCT04761588
• Lead Sponsor: Vitaflo International, Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-2-15
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Diagnosed with tyrosinaemia.<br><br> - Aged = 3 years.<br><br> - In the opinion of the Investigator, can comply with the study protocol and take at<br> least one sachet of the study product per day.<br><br> - Willingly given, written, informed consent from patient or parent/guardian.<br><br> - Willingly given, written assent (if appropriate).<br><br>Exclusion Criteria:<br><br> - Individuals who are allergic to milk, fish and soya (these allergens are inherent in<br> the study product ingredients).<br><br> - Use of additional macro/micronutrient supplements during the evaluation period,<br> unless clinically indicated and prescribed by the Investigator (must be recorded in<br> patient case report form CRF).<br><br> - Women who are pregnant / breastfeeding at the start of the study or planning to<br> become pregnant during the study.<br><br>N.B.: Women who become pregnant during the study will no longer be able to participate<br>and will be withdrawn.<br><br> - Individuals who, in the opinion of the investigator, are unable to comply with the<br> requirements of the protocol.<br><br> - Any co-morbidity, which, in the opinion of the Investigator, would preclude<br> participation in the study.<br><br> - Patients who are currently participating in, plan to participate in, or have<br> participated in an interventional investigational drug, food or medical device trial<br> within 30 days prior to screening visit.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in adherence to recommended amounts of Tyr sphere;Change in gastrointestinal tolerance;Patient evaluation of Tyr sphere's palatability;Change in metabolic control: tyrosine levels;Change in metabolic control: phenylalanine levels

Secondary Outcome Measures

Name	Time	Method
Long term change in growth;Long term change in urine succinylacetone level;Long term change in pre-albumin level;Long term change in serum albumin level