Sapropterin Dihydrochloride

• Recruiting NCT NCT02947750

  Neurovascular Transduction During Exercise in Chronic Kidney Disease

  Not yet reported Emory University 150 participants Est. completion 2027-04-30 3 sites
  Other conditions: Renal Insufficiency, Chronic
  View official trial listing →
• Recruiting NCT NCT02966665

  : Vascular Function in Health and Disease

  Not yet reported D. Walter Wray 420 participants Est. completion 2030-08 1 site
  Heart failure Other conditions: Chronic Obstructive Pulmonary Disease, Pulmonary Artery Hypertension, Hypertension
  View official trial listing →
• Recruiting NCT NCT05434195

  Clinical Antenatal Randomised Study to CharactErise Key Roles of TetrahydroFOLate in HyperTensive Pregnancies

  Not yet reported University of Oxford 128 participants Est. completion 2026-10 2 sites
  Other conditions: Pre-Eclampsia, Pregnancy Induced Hypertension, Pregnancy Related
  View official trial listing →
• Recruiting NCT NCT06312748

  Novel Approaches for Improving Vascular Function in Veterans With HFpEF

  Not yet reported VA Office of Research and Development 90 participants Est. completion 2030-09-30 1 site
  Heart failure Other conditions: Inflammation
  View official trial listing →
• Recruiting NCT NCT07728032

  Impact Of A Phe-Restricted Diet On Gut Health In Children With PKU

  Birmingham Women's and Children's NHS Foundation Trust 148 participants Est. completion 2026-12 1 site
  Other conditions: Phenylketonuria
  View official trial listing →
• Completed NCT NCT00027157

  Determination of Variances in Exhaled Nitric Oxide Output in Normal Healthy Male Volunteers Consuming High and Low Nitrate/Nitrite Diets

  National Heart, Lung, and Blood Institute (NHLBI) 18 participants Est. completion 2003-04 1 site
  Other conditions: Healthy
  View official trial listing →
• Completed NCT NCT00104247

  Study to Evaluate the Safety and Efficacy of Phenoptin™ in Subjects With Phenylketonuria Who Have Elevated Phenylalanine Levels

  Not yet reported BioMarin Pharmaceutical 89 participants Est. completion 2006-02 13 sites
  Other conditions: Phenylketonurias
  View official trial listing →
• Completed NCT NCT00104260

  Study to Evaluate the Response to and Safety of an 8-Day Course of Phenoptin™ Treatment in Subjects With Phenylketonuria

  Not yet reported BioMarin Pharmaceutical 700 participants Est. completion 2005-11 13 sites
  Other conditions: Phenylketonurias
  View official trial listing →
• Completed NCT NCT00208780

  Effects of Tetrahydrobiopterin on Blood Pressure

  Not yet reported Emory University 24 participants Est. completion 2005-12 1 site
  Other conditions: Hypertension
  View official trial listing →
• Completed NCT NCT00225615

  A Phase 3, Multicenter, Open-Label Extension Study of Phenoptin in Subjects With PKU Who Have Elevated Phenylalanine Levels

  Not yet reported BioMarin Pharmaceutical 100 participants Est. completion 2006-06 14 sites
  Other conditions: Phenylketonurias
  View official trial listing →
• Terminated NCT NCT00244218

  Response to Phenylketonuria to Tetrahydrobiopterin (BH4)

  Not yet reported The University of Texas Medical Branch, Galveston 57 participants Est. completion 2015-01 1 site
  Other conditions: Phenylketonuria
  View official trial listing →
• Completed NCT NCT00260000

  Study of BH4, a New and Simple Treatment of Mild PKU

  Not yet reported The Kennedy Institute-National Eye Clinic 15 participants Est. completion 2005-12 1 site
  Other conditions: Phenylketonuria
  View official trial listing →
• Completed NCT NCT00272792

  Study of Phenoptin to Increase Phenylalanine Tolerance in Phenylketonuric Children on a Phenylalanine-restricted Diet

  Not yet reported BioMarin Pharmaceutical 45 participants Est. completion 2006-11 9 sites Stand-alone
  Other conditions: Phenylketonurias
  View official trial listing →
• Completed NCT NCT00325962

  A Study of the Effects of 6R-BH4 on Blood Pressure in Subjects With Poorly Controlled Systemic Hypertension

  Not yet reported BioMarin Pharmaceutical 84 participants Est. completion 2008-12 24 sites
  Other conditions: Hypertension
  View official trial listing →
• Completed NCT NCT00332189

  Study of Phenoptin in Subjects With Phenylketonuria Who Participated in Protocols PKU-004 or PKU-006

  Not yet reported BioMarin Pharmaceutical 111 participants Est. completion 2009-08 14 sites
  Other conditions: Phenylketonuria
  View official trial listing →
• Completed NCT NCT00355264

  Safety and Efficacy Study of Phenoptin in Subjects With Hyperphenylalaninemia Due to BH4 Deficiency

  Not yet reported BioMarin Pharmaceutical 12 participants Est. completion 2009-06 10 sites
  Other conditions: Tetrahydrobiopterin Deficiencies, Hyperphenylalaninemia, Non-Phenylketonuric
  View official trial listing →
• Completed NCT NCT00403494

  A Phase 2 Study of the Effects of Sapropterin Dihydrochloride on Symptomatic Peripheral Arterial Disease

  Not yet reported BioMarin Pharmaceutical 190 participants Est. completion 2009-01 20 sites Stand-alone
  Alcohol use disorder
  View official trial listing →
• Status unknown NCT NCT00423280

  Effect of 6R-BH4 Treatment in Coronary Artery Disease (OXBIO Study)

  Not yet reported University of Oxford 66 participants Est. completion 2009-02 1 site
  Cardiovascular disease
  View official trial listing →
• Terminated NCT NCT00432822

  Long-Term Tetrahydrobiopterin Treatment in PKU Patients of 0-18 Years - Study on Phenylalanine Tolerance and Safety

  Not yet reported, Not yet reported Orphanetics Pharma Entwicklungs GmbH 50 participants
  Other conditions: Phenylalanine Hydroxylase Deficiencies
  View official trial listing →
• Completed NCT NCT00435331

  6R-BH4 Pulmonary Arterial Hypertension Study

  Not yet reported Vanderbilt University 14 participants Est. completion 2008-10 1 site Stand-alone
  Other conditions: Pulmonary Arterial Hypertension
  View official trial listing →
• Completed NCT NCT00445978

  A Phase 2 Study of the Effects of 6R-BH4 in Subjects With Sickle Cell Disease

  Not yet reported BioMarin Pharmaceutical 32 participants Est. completion 2009-06 12 sites Stand-alone
  Other conditions: Sickle Cell Disease
  View official trial listing →
• Approved For Marketing NCT NCT00484991

  Sapropterin Expanded Access Program

  BioMarin Pharmaceutical 36 sites
  Other conditions: Phenylketonuria
  View official trial listing →
• Completed NCT NCT00532844

  A Phase 2, Pharmacokinetic (PK) Study of 6R-BH4 Alone or 6R-BH4 With Vitamin C in Subjects With Endothelial Dysfunction

  Not yet reported BioMarin Pharmaceutical 52 participants Est. completion 2009-03 1 site Stand-alone
  Other conditions: Endothelial Dysfunction
  View official trial listing →
• Completed NCT NCT00625820

  Tetrahydrobiopterin in Patients With Chronic Kidney Disease (CKD) and Albuminuria

  Not yet reported University of Michigan 17 participants Est. completion 2008-09 1 site
  Other conditions: Kidney Disease, Albuminuria
  View official trial listing →
• Completed NCT NCT00688844

  Nutritional and Neurotransmitter Changes in PKU Subjects on BH4

  Emory University 58 participants Est. completion 2010-10 2 sites
  Other conditions: Phenylketonuria
  View official trial listing →
• Completed NCT NCT00728676

  Study to Evaluate the Effects of Kuvan on Individuals With Phenylketonuria (PKU) With Maladaptive Behaviors

  Shoji Yano 10 participants Est. completion 2010-05 1 site
  Other conditions: Phenylketonuria
  View official trial listing →
• Completed NCT NCT00730080

  Sapropterin in Individuals With Phenylketonuria

  Washington University School of Medicine 45 participants Est. completion 2018-05 1 site
  Other conditions: Phenylketonuria
  View official trial listing →
• Completed NCT NCT00778206

  PKUDOS: Phenylketonuria (PKU) Demographic, Outcomes, and Safety Registry

  BioMarin Pharmaceutical 1887 participants Est. completion 2021-01-29 45 sites
  Other conditions: Phenylketonuria, Hyperphenylalaninaemia
  View official trial listing →
• Completed NCT NCT00789568

  A Phase 1 Study to Evaluate Effects of Sapropterin Dihydrochloride on QTc Intervals in Healthy Adult Subjects

  Not yet reported BioMarin Pharmaceutical 56 participants Est. completion 2009-10 1 site Stand-alone
  Other conditions: Phenylketonuria
  View official trial listing →
• Terminated NCT NCT00802893

  Oral 6R-BH4 for the Treatment of Isolated Systolic Hypertension and Endothelial Dysfunction

  Not yet reported Johns Hopkins University 3 participants Est. completion 2009-05 1 site
  Other conditions: Isolated Systolic Hypertension, Endothelial Dysfunction
  View official trial listing →
• Terminated NCT NCT00827762

  Behavioral Effects of Kuvan in Children With Mild Phenylketonuria

  Washington University School of Medicine 2 participants Est. completion 2010-01 4 sites
  Other conditions: Phenylketonuria
  View official trial listing →
• Completed NCT NCT00838435

  Effect of Kuvan on Neurocognitive Function, Blood Phenylalanine Level, Safety, and Pharmacokinetics in Children With PKU

  Not yet reported BioMarin Pharmaceutical 95 participants Est. completion 2018-09-14 19 sites Stand-alone
  Other conditions: Phenylketonuria
  View official trial listing →
• Completed NCT NCT00841100

  Kuvan Therapy in Phenylketonuria (PKU): The Effect of Blood Phenylalanine Concentration on Kuvan Response

  Not yet reported University of Miami 21 participants Est. completion 2011-07-19 1 site Stand-alone
  Other conditions: Phenylketonuria
  View official trial listing →
• Completed NCT NCT00850070

  Sapropterin as a Treatment for Autistic Disorder

  Not yet reported The Children's Health Council 46 participants Est. completion 2011-10 1 site
  Other conditions: Autistic Disorder
  View official trial listing →
• Completed NCT NCT00919295

  Study of Indoleamine 2,3-dioxygenase Activity, Serum Levels of Cytokines, BDNF, BH4 and Mirtazapine Efficacy in Fibromyalgia Syndrome

  Not yet reported Mahidol University 80 participants Est. completion 2011-12 1 site
  Other conditions: Fibromyalgia Syndrome
  View official trial listing →
• Withdrawn NCT NCT00935753

  Trial of Kuvan in Lesch-Nyhan Disease

  Not yet reported, Not yet reported University of California, San Diego Est. completion 2010-02 1 site Stand-alone
  Other conditions: Behavioral Manifestations of Lesch-Nyhan Disease
  View official trial listing →
• Completed NCT NCT00943579

  Open-Label Extension Study of Kuvan for Autism

  Not yet reported, Not yet reported The Children's Health Council 41 participants Est. completion 2012-03 1 site Stand-alone
  Other conditions: Autistic Disorder
  View official trial listing →
• Completed NCT NCT00964236

  The Effects of Kuvan on Functional Brain Connectivity in Individuals With Phenylketonuria (PKU)

  University of Missouri-Columbia 20 participants Est. completion 2011-08 1 site
  Other conditions: Phenylketonuria
  View official trial listing →
• Completed NCT NCT00986973

  Fluorodeoxyglucose Positron Emission Tomography (FDG PET) Findings in Patients With Phenylketonuria Before and After KUVAN Therapy

  Not yet reported Children's Hospital of Philadelphia 6 participants Est. completion 2011-09 1 site Stand-alone
  Other conditions: Phenylketonuria
  View official trial listing →
• Completed NCT NCT01016392

  Observational Study on the Long Term Safety of Kuvan® Treatment in Patients With Hyperphenylalaninemia (HPA) Due to Phenylketonuria (PKU) or BH4 Deficiency

  BioMarin Pharmaceutical 627 participants Est. completion 2021-05-31 69 sites
  Other conditions: Hyperphenylalaninemia (HPA) Due to Phenylketonuria (PKU) or Tetrahydrobiopterin (BH4) Deficiency
  View official trial listing →
• Completed NCT NCT01082328

  Response to Kuvan® in Subjects With Phenylketonuria (PKU) in a 4 Weeks Testing Period

  Not yet reported Merck KGaA, Darmstadt, Germany 59 participants Est. completion 2012-05 1 site Stand-alone
  Other conditions: Phenylketonuria
  View official trial listing →
• Completed NCT NCT01114737

  Safety and Therapeutic Effects of Sapropterin Dihydrochloride on Neuropsychiatric Symptoms in Phenylketonuria (PKU) Patients

  Not yet reported BioMarin Pharmaceutical 206 participants Est. completion 2013-03 36 sites Stand-alone
  Other conditions: Phenylketonuria
  View official trial listing →
• Completed NCT NCT01135186

  Impact of KUVAN® on Gastric Relaxation in Women With Diabetic Gastroparesis.

  Not yet reported Stanford University 9 participants Est. completion 2012-11 1 site
  Other conditions: Gastroparesis
  View official trial listing →
• Completed NCT NCT01141595

  Tetrahydrobiopterin Treatment in Children With Idiopathic Cognitive Developmental Disorders

  Not yet reported The University of Texas Health Science Center, Houston 10 participants Est. completion 2011-09 1 site Stand-alone
  Other conditions: Autism Spectrum Disorder
  View official trial listing →
• Completed NCT NCT01274026

  Evaluation of Behavior, Executive Function, Neurotransmitter Function and Genomic Expression Kuvan Nonresponders

  Tulane University School of Medicine 21 participants Est. completion 2013-12 1 site
  Other conditions: Phenylketonuria, Behavior and Behavior Mechanisms, PAH Gene Expression
  View official trial listing →
• Completed NCT NCT01356966

  Exercise Intolerance in Renal Failure

  Not yet reported Emory University 74 participants Est. completion 2014-05 2 sites
  Other conditions: Kidney Failure, Chronic
  View official trial listing →
• Completed NCT NCT01376908

  Kuvan® in Phenylketonuria Patients Less Than 4 Years Old

  Not yet reported BioMarin Pharmaceutical 56 participants Est. completion 2017-02-17 22 sites Stand-alone
  Other conditions: Phenylketonuria
  View official trial listing →
• Terminated NCT NCT01395394

  Phenylketonuria, Oxidative Stress, and BH4

  Not yet reported Emory University 12 participants Est. completion 2013-06 1 site Stand-alone
  Other conditions: Phenylketonuria
  View official trial listing →
• Completed NCT NCT01398943

  Nitric Oxide Bioavailability in Chronic Obstructive Pulmonary Disease (COPD)

  Not yet reported Augusta University 60 participants Est. completion 2015-06 1 site
  Other conditions: Pulmonary Disease, Chronic Obstructive
  View official trial listing →
• Withdrawn NCT NCT01412437

  Neuroimaging and Neurocognitive Assessment and Response to Sapropterin Dihydrochloride Treatment in Phenylketonuria

  Not yet reported Children's National Research Institute Est. completion 2012-12 1 site Stand-alone
  Other conditions: PKU
  View official trial listing →
• Completed NCT NCT01425528

  Study of Kuvan Treatment in Adults With GTPCH Deficiency

  Not yet reported, Not yet reported University of Utah 12 participants Est. completion 2013-08 1 site Stand-alone
  Other conditions: GTP Cyclohydrolase Deficiency
  View official trial listing →
• Completed NCT NCT01439555

  Endothelial Facilitation in Alzheimer's Disease

  Not yet reported University of Massachusetts, Worcester 11 participants Est. completion 2017-11 1 site
  Other conditions: Alzheimer's Disease
  View official trial listing →
• Completed NCT NCT01456286

  Randomized Controlled Trial to Assess the Effects of Sapropterin on Hepatic and Systemic Hemodynamics in Patients With Liver Cirrhosis and Portal Hypertension

  Not yet reported, Not yet reported Fundacion Clinic per a la Recerca Biomédica 42 participants Est. completion 2013-10 2 sites
  Other conditions: Liver Cirrhosis, Portal Hypertension
  View official trial listing →
• Terminated NCT NCT01541397

  Bone Mineral Density in Adults With Hyperphenylalaninemia on Kuvan Therapy

  Not yet reported The University of Texas Health Science Center, Houston 6 participants Est. completion 2012-08 1 site Stand-alone
  Other conditions: Hyperphenylalaninemia, Phenylketonuria
  View official trial listing →
• Completed NCT NCT01617070

  Effects of Kuvan on Melatonin Secretion

  Not yet reported University of Southern California 10 participants Est. completion 2014-12 1 site Stand-alone
  Other conditions: Phenylketonuria (PKU)
  View official trial listing →
• Withdrawn NCT NCT01650909

  The Effects of Sapropterin Dihydrochloride Supplementation on in Vivo Redox Status in Patients With Classical PKU

  Stanford University
  Other conditions: Classical Phenylketonuria(PKU)
  View official trial listing →
• Completed NCT NCT01706965

  Kuvan in People With Schizophrenia and Schizoaffective Disorder

  Not yet reported, Not yet reported New York State Psychiatric Institute 27 participants Est. completion 2016-06 1 site Stand-alone
  Other conditions: Schizophrenia, Schizoaffective Disorder
  View official trial listing →
• Completed NCT NCT01732471

  Phase 3 Open-label Study to Evaluate the Response and Safety of Kuvan® in Subjects With Phenylketonuria

  Not yet reported Merck KGaA, Darmstadt, Germany 90 participants Est. completion 2013-10 1 site Stand-alone
  Other conditions: Phenylketonuria
  View official trial listing →
• Completed NCT NCT01772758

  Cystic Fibrosis and Endothelial Function: At Rest and During Exercise

  Not yet reported Augusta University 64 participants Est. completion 2016-06-21 1 site Stand-alone
  Other conditions: Cystic Fibrosis
  View official trial listing →
• Terminated NCT NCT01806051

  A Pilot Study on Diurnal Variation

  Not yet reported Dr. Linda Randolph 6 participants Est. completion 2014-05 1 site Stand-alone
  Other conditions: Phenylketonuria (PKU)
  View official trial listing →
• Completed NCT NCT01869972

  Biological Variation of Phenylalanine in Patients With Hyperphenylalaninemia

  Hamilton Health Sciences Corporation 32 participants Est. completion 2015-12 2 sites
  Other conditions: Phenylketonuria, Hyperphenylalaninemia
  View official trial listing →
• Completed NCT NCT01965912

  Kuvan®'s Effect on the Cognition of Children With Phenylketonuria

  Not yet reported BioMarin Pharmaceutical 34 participants Est. completion 2023-01-04 12 sites Stand-alone
  Other conditions: Phenylketonuria
  View official trial listing →
• Terminated NCT NCT01977820

  Sapropterin on Cognitive Abilities in Young Adults With Phenylketonuria

  Not yet reported BioMarin Pharmaceutical 2 participants Est. completion 2014-11 2 sites
  Other conditions: Phenylketonuria
  View official trial listing →
• Completed NCT NCT02009904

  Simple Breath Test to Examine Phenylalanine Metabolism

  University of British Columbia 20 participants Est. completion 2016-09 1 site
  Other conditions: Phenylketonuria (PKU)
  View official trial listing →
• Completed NCT NCT02012582

  Phase 2 a Study to Assess Safety and Pharmacokinetics of VAS203 in Patients With Traumatic Brain Injury

  Not yet reported veriNOS operations GmbH 32 participants Est. completion 2012-09 6 sites
  Other conditions: Traumatic Brain Injury
  View official trial listing →
• Completed NCT NCT02042196

  Sex Hormones and Atherosclerosis Prevention in Perimenopausal Women

  Not yet reported University of Colorado, Denver 100 participants Est. completion 2016-05-02 1 site Stand-alone
  Other conditions: Menopause, Aging
  View official trial listing →
• Completed NCT NCT02297347

  The Brain and Neuropsychological Functioning in Adults With Sapropterin Dihydrochloride Treated Phenylketonuria

  Boston Children's Hospital 10 participants Est. completion 2017-04 1 site
  Other conditions: Phenylketonuria
  View official trial listing →
• Completed NCT NCT02353312

  Rhode Island Diastolic Dysfunction - Heart Failure

  Not yet reported Providence VA Medical Center 28 participants Est. completion 2018-12 1 site Stand-alone
  Heart failureCardiovascular disease
  View official trial listing →
• Completed NCT NCT02530996

  Systemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and Treatment

  Not yet reported, Not yet reported VA Office of Research and Development 12 participants Est. completion 2019-12-31 1 site
  Other conditions: Rheumatologic Disease
  View official trial listing →
• Completed NCT NCT02677870

  The Effectiveness of Kuvan in Amish PKU Patients

  Not yet reported University Hospitals Cleveland Medical Center 7 participants Est. completion 2019-01-01 1 site
  Other conditions: Phenylketonuria
  View official trial listing →
• Completed NCT NCT02774226

  Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease

  Not yet reported Augusta University 15 participants Est. completion 2018-07-30 1 site Stand-alone
  Other conditions: Chronic Obstructive Pulmonary Disease (COPD)
  View official trial listing →
• Completed NCT NCT02794168

  Efficacy of VAS203 (Ronopterin) in Patients With Moderate and Severe Traumatic Brain Injury

  Not yet reported veriNOS operations GmbH 224 participants Est. completion 2020-06-30 29 sites
  Other conditions: Traumatic Brain Injury
  View official trial listing →
• Completed NCT NCT02992236

  Effects of the NO-synthase Inhibitor VAS203 on Renal Function in Healthy Volunteers

  Not yet reported veriNOS operations GmbH 16 participants Est. completion 2016-11 1 site
  Other conditions: Renal Function Impairment in Healthy Volunteers
  View official trial listing →
• Completed NCT NCT03136029

  Exercise and NO in HFrEF

  Not yet reported VA Office of Research and Development 68 participants Est. completion 2025-07-31 1 site
  Heart failure
  View official trial listing →
• Withdrawn NCT NCT03493412

  Effects of Tetrahydrobiopterin (BH4) on Leg Blood Flow and Exercise Capacity in Patients With Peripheral Artery Disease

  Not yet reported University of Nebraska Est. completion 2019-10-01 Stand-alone
  Other conditions: Peripheral Artery Disease, Peripheral Arterial Disease
  View official trial listing →
• Completed NCT NCT03519711

  A Study of PTC923 (CNSA-001) in Primary Tetrahydrobiopterin (BH4) Deficient Participants With Hyperphenylalaninemia

  Not yet reported, Not yet reported PTC Therapeutics 8 participants Est. completion 2020-10-02 4 sites
  Other conditions: BH4 Deficiency, Hyperphenylalaninemia
  View official trial listing →
• Completed NCT NCT03680573

  The Effect of Antioxidants on Skin Blood Flow-BH4

  Not yet reported The University of Texas at Arlington 16 participants Est. completion 2018-05-05 1 site
  Cardiovascular disease Other conditions: Cardiovascular Risk Factor, Vasoconstriction
  View official trial listing →
• Completed NCT NCT03820804

  Nutritional Status in Phenylketonuria

  Universidade do Porto 94 participants Est. completion 2019-09-10 1 site
  Other conditions: Phenylketonurias
  View official trial listing →
• Completed NCT NCT03841383

  Association Between Coronary Flow Reserve and BH4 Levels in High CV Risk

  IRCCS San Raffaele 55 participants Est. completion 2019-07-10 2 sites
  Other conditions: Hypertension,Essential
  View official trial listing →
• Completed NCT NCT03864029

  Retrospective Observational Safety Effectiveness With Kuvan in hpA

  BioMarin Pharmaceutical 26 participants Est. completion 2018-07-25 1 site
  Other conditions: Tetrahydrobiopterin Deficiency
  View official trial listing →
• Withdrawn NCT NCT04014712

  O2 Transport and Utilization in Health and Lung Disease

  Not yet reported University of Massachusetts, Amherst Est. completion 2022-08 1 site
  Other conditions: COPD, Tetrahydrobiopterin Deficiency, Oxidative Stress
  View official trial listing →
• Withdrawn NCT NCT04054973

  L-arginine Study for Persistent Symptoms of Schizophrenia

  Not yet reported University of Massachusetts, Worcester Est. completion 2021-12-31 1 site Stand-alone
  Other conditions: Schizo Affective Disorder, Schizophrenia
  View official trial listing →
• Status unknown NCT NCT04227080

  BH4 Responsiveness in PAH Deficiency PKU Patients

  Not yet reported Taipei Veterans General Hospital, Taiwan 40 participants Est. completion 2022-06
  Other conditions: Pku Phenylketonuria, PAH Deficiency
  View official trial listing →
• Completed NCT NCT04368624

  PKU Skin Stripping

  Children's Hospital Medical Center, Cincinnati 86 participants Est. completion 2021-04 1 site
  Other conditions: Phenylketonurias
  View official trial listing →
• Active, not recruiting NCT NCT04800692

  The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudication

  Not yet reported Louis Messina 10 participants Est. completion 2027-12 1 site
  Alcohol use disorder Other conditions: Peripheral Artery Disease, Peripheral Vascular Diseases
  View official trial listing →
• Status unknown NCT NCT05114226

  A Study for Assessing the Efficacy and Safety of Tetrahydrobiopterin in Radiation-Induced Skin Injury

  Not yet reported West China Second University Hospital 45 participants Est. completion 2024-01-01 1 site
  Other conditions: Radiation-Induced Dermatitis
  View official trial listing →
• Status unknown NCT NCT05138887

  A Study for Assessing the Efficacy and Safety of BH4 in Radiation Enteritis

  Not yet reported West China Second University Hospital 366 participants Est. completion 2024-03-01 1 site
  Other conditions: Radiation Enteritis
  View official trial listing →
• Status unknown NCT NCT05299203

  BH4 in the Prevention and Treatment of Radiation-induced Skin Reactions for Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)

  Not yet reported West China Hospital 18 participants Est. completion 2023-05 Stand-alone
  Other conditions: Head and Neck Squamous Cell Carcinoma
  View official trial listing →
• Completed NCT NCT05847361

  BH4 Blood Levels Variations in Pre Eclamptic Women

  University Tunis El Manar 300 participants Est. completion 2023-12-06 1 site
  Other conditions: Pre Eclampsia, Eclampsia, Antepartum, HELLP Syndrome (HELLP), Unspecified Trimester, Acute Renal Failure, Abruptio Placentae; Complicating Pregnancy
  View official trial listing →
• Status unknown NCT NCT06396637

  PD-1 Antibody and Sapropterin Dihydrochloride in Patients With PDAC

  Not yet reported Sun Yat-sen University 20 participants Est. completion 2025-04-30 1 site Stand-alone
  Other conditions: Pancreatic Adenocarcinoma Metastatic
  View official trial listing →
• Completed NCT NCT06481709

  Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects

  Not yet reported APR Applied Pharma Research s.a. 16 participants Est. completion 2024-08-31 1 site
  Other conditions: Bioavailability
  View official trial listing →
• Completed NCT NCT06987773

  Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects Under Fed Conditions

  Not yet reported APR Applied Pharma Research s.a. 42 participants Est. completion 2025-10-28 1 site
  Other conditions: Bioequivalence
  View official trial listing →
• Active, not recruiting NCT NCT07255599

  Evaluation of BH4 Responsiveness in Our PKU Patients

  Not yet reported Sohag University 20 participants Est. completion 2026-09-01 1 site
  Other conditions: Phenylketonuria (PKU)
  View official trial listing →
• Not yet recruiting NCT NCT07574034

  A Single Patient Study of Sapropterin for Multisystem Smooth Muscle Dysfunction Syndrome

  Not yet reported Gregor Andelfinger 1 participants Est. completion 2030-06-01 1 site Stand-alone
  Other conditions: Multisystemic Smooth Muscle Dysfunction Syndrome
  View official trial listing →
• Enrolling by invitation NCT NCT07703020

  Prevalence and Determinants of Obesity in PKU Patients

  Christel Tran 100 participants Est. completion 2029-02-01 1 site
  Other conditions: Phenylketonuria (PKU)
  View official trial listing →

Not yet reported.

Not yet reported.

• ClinicalTrials.gov — NCT07728032

Also known as: Sapropterin Dihydrochloride, Kuvan

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