Clinical trials: Pediatrics
Hyperphosphatemia
A Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent Chronic Kidney Disease (CKD) Patients With Hyperphosphataemia
This is a Phase 3, Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent CKD Patients…
- Trial name
- NCT02688764
- Testing
- PA21 (Velphoro®), Calcium Acetate (Phoslyra®)
- Where
- 38 sites in United States, France and 5 more
- Volunteers
- 85 people
- Sponsor
- Vifor Fresenius Medical Care Renal Pharma
Tumor Lysis Syndrome
Febuxostat for Tumor Lysis Syndrome Prevention in Hematological Malignancies of Paediatric Patients and Adults
The purpose of this study is to compare the exposure of febuxostat in pediatric patients (≥6<18 years of age) and in adults suffering from hematological malignancies at intermediate to high risk of TLS and to compare the effect…
- Trial name
- FLORET (NCT03605212)
- Testing
- Febuxostat
- Where
- 17 sites in Bulgaria, Hungary and 2 more
- Volunteers
- 30 people
- Sponsor
- Menarini Group
Partial-Onset or Primary Generalized Tonic-Clonic Seizures
Perampanel as Adjunctive Therapy in Pediatrics With Partial Onset Seizures or Primary Generalized Tonic Clonic Seizures
This is an open-label, multicenter study with an Extension Phase to evaluate the safety and tolerability of perampanel oral suspension when administered as an adjunctive therapy in children (ages 4 to less than [<] 12 years) with…
- Trial name
- NCT02849626
- Testing
- Perampanel
- Where
- 91 sites in United States, Belgium and 10 more
- Volunteers
- 180 people
- Sponsor
- Eisai Inc.
Non-Alcoholic Fatty Liver Disease
Gemcabene for the Treatment of Pediatric NAFLD
This is a multicenter, prospective, open-label, Phase 2, proof of concept study to test preliminary efficacy and safety of gemcabene in children with established nonalcoholic fatty liver disease (NAFLD) incompletely treated by…
- Trial name
- NCT03436420
- Testing
- Gemcabene
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Emory University
Pediatrics, Defibrillators, Implantable
Precise Measurement of Pediatric Defibrillation Thresholds
Patients who receive an implantable cardioverter-defibrillator (ICD) usually undergo testing at the end of the ICD procedure to measure the amount of energy able to successfully defibrillate the heart (defibrillation threshold…
- Trial name
- NCT01043562
- Testing
- Defibrillator threshold testing, Observation of post-shock intrinsic cardiac rhythm
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Boston Children's Hospital
Neuroblastoma, Rhabdomyosarcoma
Study to Find a Safe Dose and Show Early Clinical Activity of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent/ Refractory Solid Tumors
The purpose of this study is to find the safe dose of nab-paclitaxel in children with solid tumors, and to see if it works to treat these solid tumors in children and young adults (in Phase 1 ≤ 18 years old and in Phase 2 ≤ 24…
- Conditions
- Neuroblastoma, Rhabdomyosarcoma, Ewing's Sarcoma, Ewing's Tumor
- Trial name
- NCT01962103
- Testing
- nab-paclitaxel
- Where
- 20 sites in United States, Canada and 5 more
- Volunteers
- 107 people
- Sponsor
- Celgene
Hypertension
Effect of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children With High Blood Pressure
The purpose of this 12-week active controlled trial is to evaluate the safety and efficacy of valsartan 80/160/320 mg (weight stratified) compared with enalapril 10/20/40 mg (weight stratified) on sitting systolic blood pressure…
- Trial name
- NCT00433836
- Testing
- Valsartan, Enalapril
- Where
- 11 sites in United States, Belgium and 9 more
- Volunteers
- 300 people
- Sponsor
- Novartis Pharmaceuticals
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics
The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in subjects age 2 - 80 years, for the span of 170 hours (7 days).
- Trial name
- NCT04436822
- Testing
- Continuous Glucose Monitoring
- Where
- 18 sites in United States, China
- Volunteers
- 317 people
- Sponsor
- Medtronic MiniMed, Inc.
Gram-negative Bacterial Infections, Bloodstream Infections (BSI)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants
The primary objectives of this study are: To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric participants 3 months to < 18 years of age with suspected or confirmed…
- Conditions
- Gram-negative Bacterial Infections, Bloodstream Infections (BSI), Complicated Intra-abdominal Infection (cIAI), Hospital Acquired Pneumonia (HAP)
- Trial name
- NCT04335539
- Testing
- Cefiderocol, Standard of Care
- Where
- 23 sites in Belgium, Estonia and 7 more
- Volunteers
- 53 people
- Sponsor
- Shionogi
Major Depressive Disorder
The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder
Depression affects approximately 2.5% of children and 8% of adolescents. Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat…
- Trial name
- NCT00107120
- Testing
- Escitalopram
- Where
- 28 sites in United States
- Volunteers
- 312 people
- Sponsor
- Forest Laboratories
Glaucoma
A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma
The purpose of this study is to assess the safety and efficacy of a new formulation of bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of paediatric patients with glaucoma.
- Trial name
- NCT01426113
- Testing
- bimatoprost ophthalmic solution formulation A, timolol ophthalmic solution, bimatoprost vehicle
- Where
- 9 sites in United States, France and 5 more
- Volunteers
- 6 people
- Sponsor
- Allergan
Congenital Heart Disease
Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children
The purpose of this study is to determine whether ACE inhibitors alter the fibrinolytic, inflammatory, and hemodynamic response to cardiopulmonary bypass in infants and children with congenital heart disease.
- Trial name
- NCT00848250
- Testing
- Angiotensin Converting Enzyme Inhibitor, No ACE Inhibitor
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Vanderbilt University Medical Center
Concussions, PCS
Predicting Persistent Postconcussive Problems in Pediatrics (5P)
Concussion, a mild traumatic injury common in children and adolescents, is a complex pathophysiological process affecting the brain.
- Trial name
- 5P (NCT01873287)
- Where
- 9 sites in Canada
- Volunteers
- 3,063 people
- Sponsor
- Children's Hospital of Eastern Ontario
Pediatrics, Muscle Spasticity
BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity
This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric upper limb spasticity.
- Conditions
- Pediatrics, Muscle Spasticity, Cerebral Palsy, Stroke
- Trial name
- NCT01603615
- Testing
- Botulinum Toxin Type A
- Where
- 48 sites in United States, Canada and 7 more
- Volunteers
- 220 people
- Sponsor
- Allergan
Pediatric Obesity, Insulin Resistance
High-fat Meal Challenge in Pediatrics
The objective is to determine if how physical fitness, measured using a treadmill maximal oxidative capacity test, is associated with the capacity to metabolize a high-fat meal in pediatrics (ages 8-17 years).
- Trial name
- NCT05230433
- Testing
- High-fat Challenge
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Dartmouth-Hitchcock Medical Center
B Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia
CD19 /22 CAR T Cells (AUTO3) for the Treatment of B Cell Acute Lymphoblastic Leukemia (ALL)
The purpose of this study is to test the safety and efficacy of AUTO3, a CAR T cell treatment targeting CD19 and CD22 in paediatric or young adult patients with relapsed or refractory B cell acute lymphoblastic leukaemia.
- Conditions
- B Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Refractory Childhood Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia
- Trial name
- AMELIA (NCT03289455)
- Testing
- AUTO3 (CD19/22 CAR T cells
- Where
- 3 sites in United Kingdom
- Volunteers
- 23 people
- Sponsor
- Autolus Limited
Depressive Disorder, Major
Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)
Investigation of the efficacy and safety of a new potential treatment of Major depressive disorder (MDD) in paediatric participants (age 7 to 11 years).
- Trial name
- NCT02709655
- Testing
- Vortioxetine 10 mg/day, Vortioxetine 20 mg/day, Fluoxetine 20mg/day
- Where
- 98 sites in United States, Bulgaria and 17 more
- Volunteers
- 683 people
- Sponsor
- H. Lundbeck A/S
Cystic Fibrosis
Effect of Hypertonic Saline on Mucus Clearance in Children Ages 5-12 With Cystic Fibrosis
Previous work demonstrated that inhaled hypertonic saline (HS) reduces exacerbation frequency and improves lung function in adults with cystic fibrosis (CF).
- Trial name
- NCT01031706
- Testing
- Hypertonic Saline
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- University of North Carolina, Chapel Hill
Congenital Bleeding Disorder, Congenital FXIII Deficiency
Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency
This trial will be conducted in Asia, Europe and the United States of America (USA). The aim of this clinical trial is to investigate long-term safety of rFXIII when administered for prevention of bleeding episodes in children…
- Trial name
- mentor™5 (NCT01253811)
- Testing
- catridecacog
- Where
- 4 sites in United States, Israel and 1 more
- Volunteers
- 6 people
- Sponsor
- Novo Nordisk A/S
Anemia
Age of Blood in Children in Pediatric Intensive Care Units
ABC PICU is a randomized clinical trial that will compare the clinical consequences of RBC storage duration in 1538 critically ill children.
- Trial name
- ABC-PICU (NCT01977547)
- Testing
- Short storage RBC age
- Where
- 37 sites in United States, Canada and 3 more
- Volunteers
- 1,538 people
- Sponsor
- Washington University School of Medicine