Phenylketonuria (PKU) (DBCOND0058086)

Identifiers

Synonyms
Phenylketonurias / Pku Phenylketonuria / PKU / Phenylketonuria / Phenylalaninaemia / Phenylalaninemia / Classical phenylketonuria / Classical phenylketonuria (disorder) / Phenylketonuria I / Phenylpyruvic oligophrenia

Associated Data

Indicated Drugs and Targets
Not Available
Clinical Trials
IdentifierTitleDrug(s)PurposePhaseStatus
NCT06332807
AAV Gene Therapy Clinical Study in Adult Classic PKU (PHEdom)No drug interventionstreatment1 / 2recruiting
NCT06337864
Effect of Large Neutral Amino Acids in Adults with Classical PhenylketonuriaNo drug interventionstreatmentNot Availablenot_yet_recruiting
NCT02445521
Testing of Four Home Phenylalanine Monitoring Prototype DevicesNo drug interventionsNot AvailableNot Availablecompleted
NCT03792451
Nutrition Status of Adults Treated With PegvaliaseNot AvailableNot Availablecompleted
NCT05356377
Preliminary Study of Brain Effects of Palynziq-Related Changes in Phenylalanine in Individuals With PKUNot AvailableNot Availableenrolling_by_invitation
NCT00104247
Study to Evaluate the Safety and Efficacy of Phenoptin™ in Subjects With Phenylketonuria Who Have Elevated Phenylalanine Levelstreatment3completed
NCT04433728
Life With Phenylketonuria. Adult Neurological Outcome of PCU Screened Patients From 1971 to 2002.No drug interventionsNot AvailableNot Availableunknown_status
NCT05487378
Evaluation of Phe Fluctuation in PKU Pts Treated With PKU GOLIKE Versus Standard Amino Acid Protein Substitute.No drug interventionstreatmentNot Availablecompleted
NCT05222178
Safety and Efficacy of HMI-103 in Participants With Classical PKU Due to PAH Deficiencytreatment1terminated
NCT05096988
Evaluation of PKU Sphere LiquidNo drug interventionstreatmentNot Availablecompleted
NCT04969809
Comparison of Atherogenic Risk Factors and Efficacy of Nutritional Treatment Among Adult Phenylketonuria PatientsNo drug interventionstreatmentNot Availablenot_yet_recruiting
NCT05174559
Additional Dietary Large Neutral Amino Acids (LNAA) for Improved Symptoms in Adult Classical Phenylktonuria (PKU)No drug interventionstreatmentNot Availableactive_not_recruiting
NCT06560736
Development of Novel Psychological Assessment Tools and Anxiety Intervention for PhenylketonuriaNo drug interventionstreatmentNot Availablenot_yet_recruiting
NCT05249218
Impact of Fruit and Vegetables in PKUNo drug interventionsotherNot Availablecompleted
NCT01209819
Bone Mineral Density in Adults With HyperphenylalaninemiaNo drug interventionsNot AvailableNot Availablecompleted
NCT05971563
Amino Acid Kinetics of GMP-AA in Healthy Human VolunteersNo drug interventionsotherNot Availableactive_not_recruiting
NCT04768348
Natural History Clinical Study in Adult PKUNo drug interventionsNot AvailableNot Availableterminated
NCT03777826
Effects of Synergy on Nutrient Intake and Acceptability in Phenylketonuria (PKU)No drug interventionstreatmentNot Availablecompleted
NCT03333720
Compliance, Tolerance and Acceptability of a Tablet Protein Substitute for the Dietary Management of PhenylketonuriaNo drug interventionssupportive_careNot Availablewithdrawn
NCT04076176
The Effects of CGMP in Children and Adults With PKUNo drug interventionstreatmentNot Availablecompleted
NCT04251494
A Study Into the Future Cardiovascular Disease (CVD) Risk of Phenylketonuria (PKU) Patients on a Low Phenylalanine Treatment Diet (LPD).No drug interventionsNot AvailableNot Availableunknown_status
NCT04898829
Evaluation of PKU Explore FranceNo drug interventionssupportive_careNot Availableactive_not_recruiting
NCT00272792
Study of Phenoptin to Increase Phenylalanine Tolerance in Phenylketonuric Children on a Phenylalanine-restricted Diettreatment3completed
NCT04375592
Acceptability and Tolerance of a Ready-to-use Protein Substitute in Tablet Form for the Dietary Management of PhenylketonuriaNo drug interventionsNot AvailableNot Availablecompleted
NCT04679467
Evaluation of PKU Sphere in ItalyNo drug interventionssupportive_careNot Availablecompleted
NCT03820804
Nutritional Status in PhenylketonuriaNot AvailableNot Availablecompleted
NCT06061614
Safety and Efficacy Study of NGGT002 in PKU Adult SubjectsNo drug interventionstreatment0recruiting
NCT05497050
The Effect of Nursing Empowerment ProgramNo drug interventionssupportive_careNot Availablecompleted
NCT03655223
Early Check: Expanded Screening in NewbornsNo drug interventionsNot AvailableNot Availableenrolling_by_invitation
NCT03856203
Nutrition Status of Adults With PKU Before and During Treatment With PegvaliaseNo drug interventionsNot AvailableNot Availablecompleted
NCT06332105
Evaluation of Low Phenylalanine FormulasNo drug interventionstreatmentNot Availableactive_not_recruiting
NCT03167697
Evaluating the Efficacy of PKU Synergy in Patients Expressing Phenylketonuria or HyperphenylalaninemiaNo drug interventionssupportive_careNot Availablecompleted
NCT04943393
Remote Neurocognitive and Psychological Assessment in PKUNo drug interventionsNot AvailableNot Availablecompleted
NCT04318509
Market Research - Acceptability Study for a New PKU Protein SubstituteNo drug interventionsotherNot Availablecompleted
NCT05998109
PheCheck Feasibility StudyNo drug interventionsNot AvailableNot Availablerecruiting
NCT03952156
Gene Therapy Clinical Study in Adult PKUNo drug interventionstreatment1 / 2terminated
NCT00225615
A Phase 3, Multicenter, Open-Label Extension Study of Phenoptin in Subjects With PKU Who Have Elevated Phenylalanine Levelstreatment3completed
NCT04210206
Short-term Effects of Good Metabolic Control on Cognitive Function, Wellbeing, and Metabolic Parameters in Adult Patients With PhenylketonuriaNo drug interventionstreatmentNot Availableterminated
NCT05128149
Metabolic Control and Patient Well-being in Phenylketonuria: do Guidelines Make a Difference?No drug interventionsNot AvailableNot Availablerecruiting
NCT05229549
Study to Evaluate the Effect on Nitrogen Retention of Two Different Posology Schemes of PKU GOLIKE PLUS 3-16 and Free AAs in Patients With PhenylketonuriaNo drug interventionstreatmentNot Availableterminated
NCT05827536
Open-label, Randomized, 2-way Crossover, Monocentric, Controlled Study to Evaluate the Effect on Daily PHE Fluctuation of PKU GOLIKE Versus SoC in Patients With PKU.No drug interventionstreatmentNot Availablerecruiting
NCT04272736
PKU Low Calorie Drink StudyNo drug interventionssupportive_careNot Availablenot_yet_recruiting
NCT04452513
A Prospective Clinical Study of Phenylketonuria (PKU)No drug interventionsNot AvailableNot Availablecompleted
NCT03419819
Evaluation of PKU SphereNo drug interventionstreatmentNot Availablecompleted
NCT04368624
PKU Skin StrippingNo drug interventionsNot AvailableNot Availablecompleted
NCT04110496
Safety and Tolerability of RTX-134 in Adults With PhenylketonuriaNo drug interventionstreatment1terminated
NCT04404530
Nutritional Impacts of Palynziq on Patients With Phenylketonuria (PKU)Not AvailableNot Availablerecruiting
NCT05051657
Evaluation of the Express Plus RangeNo drug interventionssupportive_careNot Availablerecruiting
NCT04309331
Market Research - Acceptability Trial for a New PKU Amino Acid Based Protein SubstituteNo drug interventionsotherNot Availablecompleted
NCT00104260
Study to Evaluate the Response to and Safety of an 8-Day Course of Phenoptin™ Treatment in Subjects With Phenylketonuriatreatment2completed
NCT04302194
Early Dietary Treated Patients With Phenylketonuria Can Achieve Normal Growth and Mental Development.No drug interventionsNot AvailableNot Availableunknown_status
NCT03771391
A 16 Week Study Evaluating the Introduction of a GMP Based Protein Substitute in Participants With PKUNo drug interventionstreatmentNot Availablecompleted
NCT04248062
Patient and Observer Reported Outcome Measurements in Inborn Errors of MetabolismNo drug interventionsNot AvailableNot Availablecompleted
NCT04256655
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of CDX 6114 in PKU PatientsNo drug interventionstreatment1withdrawn
NCT04227080
BH4 Responsiveness in PAH Deficiency PKU Patientstreatment4unknown_status
NCT06628128
A Study to Evaluate the Long-Term Safety and Efficacy of JNT-517 in Participants with Phenylketonuriatreatment3not_yet_recruiting
NCT01806051
A Pilot Study on Diurnal VariationNot AvailableNot Availableterminated
NCT03694353
Safety and Efficacy of Self Administered Injections of Pegvaliase (>40mg/Day Dose) in Adults With PKUtreatment3completed
NCT03309345
Body Composition, Energy Intake and Expenditure in People With PhenylketonuriaNo drug interventionsNot AvailableNot Availableunknown_status
NCT04086511
PANDA: PKU Amino Acid EvaluationNo drug interventionsNot AvailableNot Availablecompleted
NCT05270837
Study to Evaluate the Safety and Efficacy of Pegvaliase in Adolescents (Ages 12-17) With Phenylketonuriatreatment3active_not_recruiting
NCT01617070
Effects of Kuvan on Melatonin Secretiontreatment4completed
NCT06305234
A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade)Not AvailableNot Availablerecruiting
NCT03505125
A Non-Interventional Interview Study of Phenylketonuria (PKU) AdultsNo drug interventionsNot AvailableNot Availablecompleted
NCT01889862
Phase 3 Study to Evaluate the Efficacy & Safety of Self-Administered Injections of BMN165 by Adults With PKUtreatment3completed
NCT04480567
AAV Gene Therapy Study for Subjects With PKUtreatment1 / 2active_not_recruiting
NCT02009904
Simple Breath Test to Examine Phenylalanine MetabolismNo drug interventionsNot AvailableNot Availablecompleted
NCT05813678
A Long-term, Post-marketing Safety Study of Palynziq in Patients With PKU (PALace)Not AvailableNot Availablerecruiting
NCT02440932
Impact of Phenylketonuria-type Diet on Appetite, Appetite Hormones and Diet Induced ThermogenesisNo drug interventionsNot AvailableNot Availablecompleted
NCT06629987
Determining the Most Efficient Screening Cut Off Levels for Phenylketonuria (PKU)No drug interventionsNot AvailableNot Availablecompleted
NCT05062226
GMP Case Studies of Tolerance, Safety and Acceptability in PKU and TYRNo drug interventionsotherNot Availablecompleted
NCT01904708
Moderate Intensity Exercise and PhenylketonuriaNo drug interventionsbasic_scienceNot Availableterminated
NCT02212288
Antioxidant Signature in Adult Patients With PhenylketonuriaNo drug interventionsNot AvailableNot Availablecompleted
NCT03913156
Feeding Patterns and Practices in Young Children With PKU During the First Two Years of LifeNo drug interventionsotherNot Availablecompleted
NCT01412437
Neuroimaging and Neurocognitive Assessment and Response to Sapropterin Dihydrochloride Treatment in PhenylketonuriadiagnosticNot Availablewithdrawn
NCT05995717
Evaluation of PKU UPNo drug interventionstreatmentNot Availablerecruiting
NCT01619722
Study of a National Cohort of Adult Patients With PhenylketonuriaNo drug interventionsNot AvailableNot Availablecompleted
NCT05166161
A Long-Term Safety Study of PTC923 in Participants With Phenylketonuriatreatment3recruiting
NCT06302348
A Study of Sepiapterin in Participants With Phenylketonuria (PKU)treatment3recruiting
NCT00924703
Long-Term Extension of Previous rAvPAL-PEG Protocols in Subjects With PKU (PAL-003)treatment2completed
NCT03516487
Safety and Tolerability of SYNB1618 in Healthy Adult Volunteers and Adult Subjects With PhenylketonuriaNo drug interventionstreatment1 / 2completed
NCT00892554
The Effect of Supplemental Docosahexaenoic Acid (DHA) on Neurocognitive Outcomes in Teen and Adult Women With Phenylketonuria(PKU)No drug interventionspreventionNot Availablecompleted
NCT01082328
Response to Kuvan® in Subjects With Phenylketonuria (PKU) in a 4 Weeks Testing Periodtreatment4completed
NCT01732471
Phase 3 Open-label Study to Evaluate the Response and Safety of Kuvan® in Subjects With Phenylketonuriatreatment3completed
NCT02677870
The Effectiveness of Kuvan in Amish PKU Patientstreatment4completed
NCT00006142
Study of a Phenylalanine Restricted Diet During Pregnancy to Prevent Symptoms in Offspring of Patients With PhenylketonuriaNo drug interventionspreventionNot Availablecompleted
NCT00065299
Low Phenylalanine Diet for Mothers With Phenylketonuria (PKU)No drug interventionstreatmentNot Availablecompleted
NCT03168399
Evaluation of PKU ExploreNo drug interventionstreatmentNot Availablecompleted
NCT05781399
First-in-Human, Multiple Part Clinical Study of JNT-517 in Healthy Participants and in Participants With Phenylketonuriatreatment1recruiting
NCT01659749
Educational, Social Support, and Nutritional Interventions and Their Cumulative Effect on Pregnancy Outcomes and Quality of Life in Teen and Adult Women With PhenylketonuriaNo drug interventionspreventionNot Availablerecruiting
NCT01428258
Phase 2 Study of Glycomacropeptide Versus Amino Acid Diet for Management of PhenylketonuriaNo drug interventionstreatmentNot Availablecompleted
NCT00838435
Effect of Kuvan on Neurocognitive Function, Blood Phenylalanine Level, Safety, and Pharmacokinetics in Children With PKUtreatment3completed
NCT05764239
Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3)No drug interventionstreatment3terminated
NCT05894122
Evaluation of Capillary Blood Collection Devices (Mitra® and HemaPEN®)No drug interventionsNot AvailableNot Availablerecruiting
NCT03058848
Evaluation of PKU StartNo drug interventionstreatmentNot Availablecompleted
NCT01924026
Neurocognitive Outcomes in Mild Hyperphenylalaninemia (MHP)MHP StudyNo drug interventionsNot AvailableNot Availablecompleted
NCT01274026
Evaluation of Behavior, Executive Function, Neurotransmitter Function and Genomic Expression Kuvan NonrespondersNot AvailableNot Availablecompleted
NCT04085666
Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of CDX-6114 in Patients With Phenylketonuria (PKU)No drug interventionsother1completed
NCT00986973
Fluorodeoxyglucose Positron Emission Tomography (FDG PET) Findings in Patients With Phenylketonuria Before and After KUVAN TherapytreatmentNot Availablecompleted
NCT01819727
An Open-Label Phase 3 Study of BMN 165 for Adults With PKU Not Previously Treated w/ BMN 165treatment3completed
NCT00728676
Study to Evaluate the Effects of Kuvan on Individuals With Phenylketonuria (PKU) With Maladaptive BehaviorsNo drug interventionsNot AvailableNot Availablecompleted
NCT00484991
Sapropterin Expanded Access ProgramNot AvailableNot Availableapproved_for_marketing
NCT00730080
Sapropterin in Individuals With PhenylketonuriaNot AvailableNot Availablecompleted
NCT05972629
A Phase 1/Phase 2 Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of a Single Intravenous Administration of SAR444836 in Adult Participants With PhenylketonuriaNo drug interventionstreatment1 / 2recruiting
NCT01212744
Safety, Tolerability, and Efficacy Study of rAvPAL-PEG Administered Daily in Subjects With Phenylketonuria (PKU)treatment2completed
NCT01917344
The Brain, Neurological Features and Neuropsychological Functioning in Adults With Phenylketonuria: A Pilot StudyNo drug interventionsdiagnosticNot Availablecompleted
NCT00688844
Nutritional and Neurotransmitter Changes in PKU Subjects on BH4Not AvailableNot Availablecompleted
NCT03858101
SNAP: Study Nutrients in Adult PKUNo drug interventionsNot AvailableNot Availablecompleted
NCT00789568
A Phase 1 Study to Evaluate Effects of Sapropterin Dihydrochloride on QTc Intervals in Healthy Adult Subjectstreatment1completed
NCT00909012
Quantitative Requirements of Docosahexaenoic Acid for Neural Function in Children With PhenylketonuriaNo drug interventionsbasic_scienceNot Availablecompleted
NCT01965912
Kuvan®'s Effect on the Cognition of Children With Phenylketonuriatreatment4completed
NCT02915510
GMP Drink for PKU StudyNo drug interventionssupportive_careNot Availablecompleted
NCT03097250
MRI Spectroscopy and Neuropsychological Functioning in PhenylketonuriaNo drug interventionsNot AvailableNot Availablecompleted
NCT04348708
Long-Term Follow Up Study of Subjects Previously Administered HMI 102No drug interventionsNot AvailableNot Availableenrolling_by_invitation
NCT01376908
Kuvan® in Phenylketonuria Patients Less Than 4 Years Oldtreatment3completed
NCT02176603
Observational Study of Endothelial Dysfunction in PhenylketonuriaNo drug interventionsNot AvailableNot Availablecompleted
NCT02555579
Simplified Diet Approach in PhenylketonuriaNo drug interventionstreatmentNot Availablecompleted
NCT00925054
Dose-Finding Study to Evaluate the Safety, Efficacy, & Tolerability of Multiple Doses of rAvPAL-PEG in Subjects With PKUtreatment2completed
NCT04879277
Study of Low-grade Systemic Inflammation in Adult Patients With PhenylketonuriaNo drug interventionsscreeningNot Availablecompleted
NCT02297347
The Brain and Neuropsychological Functioning in Adults With Sapropterin Dihydrochloride Treated PhenylketonuriaNo drug interventionsNot AvailableNot Availablecompleted
NCT01541397
Bone Mineral Density in Adults With Hyperphenylalaninemia on Kuvan TherapytreatmentNot Availableterminated
NCT06147856
A Dose-finding Study to Evaluate mRNA-3210 in Participants With PhenylketonuriaNo drug interventionstreatment1 / 2active_not_recruiting
NCT01114737
Safety and Therapeutic Effects of Sapropterin Dihydrochloride on Neuropsychiatric Symptoms in Phenylketonuria (PKU) Patientstreatment3completed
NCT03939052
Protein Requirements in Adults With Phenylketonuria (PKU)No drug interventionssupportive_careNot Availablecompleted
NCT00260000
Study of BH4, a New and Simple Treatment of Mild PKUtreatment2completed
NCT01465100
Liver Cell Transplant for PhenylketonuriaNo drug interventionstreatment1 / 2terminated
NCT00841100
Kuvan Therapy in Phenylketonuria (PKU): The Effect of Blood Phenylalanine Concentration on Kuvan Responsetreatment2completed
NCT00309400
The Early History of Universal Screening for Metabolic DisordersNo drug interventionsNot AvailableNot Availablecompleted
NCT02468570
A Phase 3 Substudy to Evaluate Executive Function in Adults With PKU Who Are Participating in the Phase 3 Study, 165-302No drug interventionsNot AvailableNot Availablecompleted
NCT04534842
Efficacy and Safety of SYNB1618 and SYNB1934 in Adult Patients With Phenylketonuriatreatment2completed
NCT00778206
PKUDOS: Phenylketonuria (PKU) Demographic, Outcomes, and Safety RegistryNot AvailableNot Availablecompleted
NCT00964236
The Effects of Kuvan on Functional Brain Connectivity in Individuals With Phenylketonuria (PKU)Not AvailableNot Availablecompleted
NCT00244218
Response to Phenylketonuria to Tetrahydrobiopterin (BH4)treatment1terminated
NCT01096758
Follow-up of Adult Phenylketonuria (PKU) PatientsNo drug interventionsNot AvailableNot Availablecompleted
NCT01560286
A Study to Evaluate Subcutaneously Administered rAvPAL-PEG in Patients With Phenylketonuria for 24 Weekstreatment2completed
NCT06289348
Announcement of Rare Metabolic Diseases in Systematic Newborn Screening: the Phenylketonuria Experience.No drug interventionsNot AvailableNot Availablenot_yet_recruiting
NCT05948020
Efficacy and Safety of Orally Administered Engineered Probiotics (CBT102-A) for the Treatment of Children With PhenylketonuriaNo drug interventionstreatmentNot Availablerecruiting
NCT01977820
Sapropterin on Cognitive Abilities in Young Adults With Phenylketonuriatreatment2terminated
NCT00634660
Safety and Tolerability Study of rAvPAL-PEG to Treat Phenylketonuriatreatment1completed
NCT01395394
Phenylketonuria, Oxidative Stress, and BH4Not Available2terminated
NCT01965691
Protein Requirements in Children With Phenylketonuria (PKU)No drug interventionssupportive_careNot Availablecompleted
NCT00827762
Behavioral Effects of Kuvan in Children With Mild PhenylketonuriaNot AvailableNot Availableterminated
NCT00332189
Study of Phenoptin in Subjects With Phenylketonuria Who Participated in Protocols PKU-004 or PKU-006treatment3completed
NCT05099640
A Study of PTC923 in Participants With PhenylketonuriaNo drug interventionstreatment3completed
NCT01869972
Biological Variation of Phenylalanine in Patients With HyperphenylalaninemiaNo drug interventionsNot AvailableNot Availablecompleted
NCT03788343
Phenylalanine and Its Impact on CognitionNo drug interventionssupportive_care4completed