240. Phenylketonuria Clinical trials / Disease details
Clinical trials : 143 / Drugs : 90 - (DrugBank : 10) / Drug target gene : 1 - Drug target pathways : 5
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05096988 (ClinicalTrials.gov) | November 23, 2021 | 14/10/2021 | Evaluation of PKU Sphere Liquid | A Study to Evaluate the Acceptability, Tolerance and Adherence of Children and Adults Consuming PKU Sphere Liquid, a Food for Special Medical Purposes (FSMP), for the Dietary Management of Phenylketonuria (PKU) | Phenylketonurias | Dietary Supplement: PKU sphere liquid | Vitaflo International, Ltd | NULL | Active, not recruiting | 3 Years | N/A | All | 19 | N/A | United Kingdom |
| 2 | NCT04679467 (ClinicalTrials.gov) | January 15, 2020 | 26/11/2020 | Evaluation of PKU Sphere in Italy | An Acceptability Study to Evaluate the Tolerance, Adherence and Metabolic Control of Patients With Phenylketonuria (PKU) Consuming PKU Sphere™, a Glycomacropeptide (GMP) Based Protein Substitute, When Introduced According to a Practical Guide to PKU Sphere. | Phenylketonurias;PKU | Dietary Supplement: PKU sphere | Vitaflo International, Ltd | NULL | Completed | 3 Years | N/A | All | 13 | N/A | Italy |
| 3 | NCT04224142 (ClinicalTrials.gov) | July 29, 2019 | 7/10/2019 | Evaluation of PKU Sphere in Maternal PKU | An Observational Study to Evaluate Metabolic Control and Dietary Management in Women With PKU Taking PKU Sphere During Pre-conception and/or Pregnancy | Maternal Phenylketonuria | Dietary Supplement: PKU sphere | Vitaflo International, Ltd | University College London Hospitals | Recruiting | 16 Years | N/A | Female | 10 | United Kingdom | |
| 4 | NCT03939052 (ClinicalTrials.gov) | July 19, 2019 | 1/5/2019 | Protein Requirements in Adults With Phenylketonuria (PKU) | Protein Requirements in Phenylketonuria (PKU) Patients Compared Using PKU Sphere™ | Glycomacropeptide (GMP) and an L-amino Acid-based Product | Phenylketonuria | Dietary Supplement: Free amino acids intake | University of British Columbia | Vitaflo International, Ltd | Recruiting | 19 Years | 50 Years | All | 6 | N/A | Canada |
| 5 | NCT03771391 (ClinicalTrials.gov) | December 6, 2018 | 7/12/2018 | A 16 Week Study Evaluating the Introduction of a GMP Based Protein Substitute in Participants With PKU | Multicentre Study Project to Evaluate the New Generation of Protein Supplements With Glycomacropeptide (GMP) in Patients With Phenylketonuria (PKU) Aged 10 Years and Older Over a 16 Week Period. | Phenylketonurias | Dietary Supplement: PKU Sphere | Vitaflo International, Ltd | Kreiskliniken Reutlingen;Johannes Gutenberg University Mainz | Active, not recruiting | 10 Years | N/A | All | 15 | N/A | Germany |
| 6 | NCT03419819 (ClinicalTrials.gov) | May 1, 2018 | 3/1/2018 | Evaluation of PKU Sphere | Evaluation of the Acceptability, Tolerance, and Satiety of PKU Sphere, a Glycomacropeptide (GMP) Based Medical Food in Patients With Phenylketonuria (PKU). | Phenylketonurias | Dietary Supplement: PKU Sphere | Vitaflo International, Ltd | Oregon Health and Science University | Completed | 3 Years | N/A | All | 28 | N/A | United States |