Clinical trials: Pediatric Safety and Effectiveness
AML, Childhood, Relapse/Recurrence
Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation
The purpose of this study is to evaluate the efficacy and safety of avapritinib in relapsed or refractory pediatric core binding factor acute myeloid leukemia with KIT mutation.
- Conditions
- AML, Childhood, Relapse/Recurrence, Refractory AML, Core Binding Factor Acute Myeloid Leukemia
- Trial name
- NCT06316960
- Testing
- Avapritinib, Azacitidine Injection, Decitabine Injection
- Where
- 12 sites in China
- Volunteers
- 50 people
- Sponsor
- Children's Hospital of Soochow University
Secondary Hyperparathyroidism-Chronic Kidney Disease
Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
Primary Objective: Evaluated the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH). Secondary Objectives: Evaluated the safety profile of Hectorol® capsules versus Rocaltrol®…
- Trial name
- NCT02859896
- Testing
- Doxercalciferol (GZ427397), Calcitriol
- Where
- 23 sites in United States, Chile
- Volunteers
- 21 people
- Sponsor
- Sanofi
Relapsed or Refractory Pediatric Malignant Solid Tumors (Including Neuroblastoma, Rhabdomyosarcoma, Ewing Sarcoma, Osteosarcoma)
Liposomal Irinotecan, Vincristine, Temozolomide, and Anlotinib for R/R Pediatric Solid Tumors
This is a prospective, single-center, single-arm interventional trial conducted at Tianjin Medical University Cancer Institute and Hospital.
- Trial name
- NCT07444918
- Testing
- Liposomal Irinotecan, Vincristine, Temozolomide, and Optional Anlotinib
- Volunteers
- 33 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Multiple Sclerosis, Relapsing-Remitting
A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis
This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric…
- Trial name
- NCT03958877
- Testing
- BIIB017 (peginterferon beta-1a), Interferon beta type 1a
- Where
- 65 sites in United States, Argentina and 20 more
- Volunteers
- 152 people
- Sponsor
- Biogen
MRI, Pediatric Sedation
Intranasal Dexmedetomidine Versus Oral Midazolam as Premedication for Propofol Sedation in Pediatric Patients Undergoing Magnetic Resonance Imaging
A magnetic resonance imaging (MRI) examination usually takes 30 to 45 minutes and requires the patient to remain perfectly still during the entire acquisition process to ensure quality.
- Conditions
- MRI, Pediatric Sedation, Midazolam, Dexmedetomidine
- Trial name
- NCT05192629
- Testing
- Dexmedetomidine, Midazolam
- Where
- Belgium
- Volunteers
- 250 people
- Sponsor
- Brugmann University Hospital
Gaucher's Disease Type I, Gaucher's Disease Type III
Safety and Efficacy of Eliglustat With or Without Imiglucerase in Pediatric Patients With Gaucher Disease (GD) Type 1 and Type 3
Primary Objective: Evaluated the safety and pharmacokinetics of eliglustat in pediatric participants (≥2 to <18 years old). Secondary Objective: Evaluated the efficacy of eliglustat and quality of life in pediatric participants…
- Trial name
- ELIKIDS (NCT03485677)
- Testing
- Eliglustat GZ385660, Imiglucerase GZ437843
- Where
- 21 sites in Argentina, Canada and 8 more
- Volunteers
- 57 people
- Sponsor
- Sanofi
Rhabdomyosarcoma, Pediatric Cancer
Effectiveness of Pucotenlimab Combined With Standard Chemotherapy Regimen
This study comprises both Phase I and Phase II research. This phase focuses on safety, tolerability, and pharmacokinetics using a "3+3" dose escalation design with three dose groups: 1 mg/kg, 3 mg/kg, and 6 mg/kg.
- Trial name
- NCT06456892
- Testing
- Pucotenlimab
- Where
- China
- Volunteers
- 82 people
- Sponsor
- Sun Yat-sen University
Heterozygous Familial Hypercholesterolemia (HeFH)
A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
This study is designed to learn if enlicitide decanoate is safe and effective to treat children and adolescents with heterozygous familial hypercholesterolemia (HeFH) and high amounts of low-density lipoprotein cholesterol…
- Trial name
- NCT07058077
- Testing
- Enlicitide Decanoate
- Where
- 47 sites in United States, Australia and 17 more
- Volunteers
- 153 people
- Sponsor
- Merck Sharp & Dohme LLC
ADHD, ADD
Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder
The purpose of this study is to determine which dosages of dexmethylphenidate HCl extended-release capsules may represent effective treatment for ADHD in children 6-12 years of age.
- Trial name
- NCT00301236
- Testing
- Dexmethylphenidate HCl extended-release capsules
- Where
- 25 sites in United States
- Volunteers
- 252 people
- Sponsor
- Novartis
Pediatric Cancer
Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Patients
The purpose is to evaluate the effectiveness and safety of fosaprepitant plus ondansetron with dexamethasone or placebo plus ondansetron with dexamethasone in preventing chemotherapy-induced nausea and vomiting (CINV) with MEC/HE…
- Trial name
- NCT04508400
- Testing
- Fosaprepitant,ondansetron, dexamethasone
- Where
- China
- Volunteers
- 108 people
- Sponsor
- Sun Yat-sen University
Chronic Kidney Diseases
N-acetyl Cysteine: the Effectiveness and Safety in a Cohort of Pediatric Patients With Chronic Kidney Disease
Anemia is a common comorbidity of CKD and is associated with a decreased quality of life and increased healthcare resource utilization.
- Trial name
- NCT04916080
- Testing
- N-acetyl cysteine
- Where
- 2 sites in Egypt
- Volunteers
- 50 people
- Sponsor
- Beni-Suef University
Crohn's Disease
A Study to Test Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Crohn's Disease
The purpose of the study is to assess efficacy, safety and tolerability of 2 dose regimens of certolizumab pegol
- Trial name
- NCT04643483
- Testing
- Certolizumab pegol, Adalimumab
- Sponsor
- UCB Biopharma SRL
Pediatric Cancer
Safety and Efficacy of PEG-rhG-CSF in Preventing Neutropenia in Children With Tumor After Chemotherapy
The purpose is to evaluate the safety of PEG-rhG-CSF in the prevention of neutropenia in children with tumor after chemotherapy, and then evaluate the effectiveness of PEG-rhG-CSF in preventing neutropenia in children with tumor…
- Trial name
- NCT04547829
- Testing
- pegylated recombinant human granulocyte-colony stimulating factor
- Where
- China
- Volunteers
- 108 people
- Sponsor
- Sun Yat-sen University
HIV-1, HIV Infection
DOR/ISL in Pediatric Participants With HIV-1, <18 Years of Age and ≥ 35 kg
This is a phase 2 study of the pharmacokinetics, safety, and efficacy of oral doravirine/islatravir (100 mg/0.25 mg) [MK-8591A] in pediatric participants with human immunodeficiency virus type 1 (HIV-1) infection who are…
- Trial name
- NCT07862569
- Testing
- DOR/ISL
- Volunteers
- 45 people
- Sponsor
- Merck Sharp & Dohme LLC
Pediatric Central Nervous System Tumors, Medulloblastoma
Safety and Efficacy of Vertebral Body-Sparing Craniospinal Irradiation With Proton Therapy in Pediatric Tumors
his is a single-center, prospective observational study in children and adolescents with central nervous system tumors who need whole-brain and whole-spine radiation therapy (craniospinal irradiation, CSI).
- Conditions
- Pediatric Central Nervous System Tumors, Medulloblastoma, Germinoma, Ependymoma
- Trial name
- VBS-CSI-PT-PED (NCT07589361)
- Testing
- Vertebral Body-Sparing Craniospinal Proton Irradiation
- Volunteers
- 38 people
- Sponsor
- Ruijin Hospital
HIV-infected Children
Pediatric Study for Appropriate Dose of Ritonavir Boosted Lopinavir in Thai HIV-infected Children (PEARL)
To compare the safety and efficacy of low-dose versus standard dose lopinavir/ritonavir containing HAART regimen in virological suppress, HIV RNA viral load < 50 copies/ml at 48 week
- Trial name
- NCT01307124
- Testing
- kaletra
- Where
- 10 sites in Thailand
- Volunteers
- 199 people
- Sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
Type 2 Diabetes Mellitus
Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)
This study evaluated the safety and efficacy of ertugliflozin (MK-8835) in pediatric participants with T2DM on metformin with/without insulin.
- Trial name
- NCT04029480
- Testing
- Ertugliflozin 5 mg, Ertugliflozin 15 mg, Insulin
- Where
- 104 sites in United States, Belgium and 20 more
- Volunteers
- 166 people
- Sponsor
- Merck Sharp & Dohme LLC
Disorder of Consciousness
Safety and Efficacy of tDCS in Pediatric DoC
Background: Despite established evidence supporting the use of tDCS in the adult patient with disorders of consciousness, its use in paediatric patients with brain injury is still limited.
- Trial name
- tDCS-DoC-Ped (NCT05929274)
- Testing
- tDCS
- Sponsor
- Giovanna Cristella
Caudal Block
Methylprednisolone Versus Dexamethasone in Pediatric Caudal Block
This randomized, double-blind, controlled bi-center study was designed to compare the postoperative analgesic efficacy of dexamethasone and methylprednisolone in caudal block for children undergoing hypospadias surgical repair…
- Trial name
- NCT05717374
- Testing
- caudal block using dexamethasone, caudal block using methylprednisolone
- Where
- Egypt
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Mansoura University
Aspergillosis, Invasive Pulmonary Aspergillosis
Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects
This study aims to compare the safety, tolerability, and efficacy of voriconazole and anidulafungin in combination versus voriconazole alone in pediatric subjects aged 2 to 17 years with invasive aspergillosis.
- Conditions
- Aspergillosis, Invasive Pulmonary Aspergillosis, Neuroaspergillosis
- Trial name
- NCT01188759
- Testing
- Voriconazole, Anidulafungin
- Sponsor
- Pfizer
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