Clinical trials: Pediatric Population
Non-Hodgkin Lymphoma
Phase II Open Label Trial to Determine Safety & Efficacy of Tisagenlecleucel in Pediatric Non-Hodgkin Lymphoma Patients
The purpose of the study was to assess the efficacy and safety of tisagenlecleucel in pediatric, adolescent and young adult patients with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) including Burkitt Lymphoma and…
- Trial name
- BIANCA (NCT03610724)
- Testing
- Tisagenlecleucel, lymphodepleting chemotherapy, Bridging Therapy
- Where
- 26 sites in United States, Australia and 12 more
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
Postoperative Infection
Safety of 1 g and 2 g of Cefazolin in Pediatric Subjects
This is a Phase 4, open-label, single-dose, parallel-group, multicenter, safety study of cefazolin (1 g or 2 g) in pediatric subjects between 10 and 17 years of age (inclusive) scheduled for surgery.
- Trial name
- NCT03231228
- Testing
- Cefazolin 1 g Infusion, Cefazolin 2 g Infusion
- Where
- 5 sites in United States
- Volunteers
- 61 people
- Sponsor
- B. Braun Medical Inc.
Somatostatin Receptor Positive, NETs
Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors
The purpose of the study is to determine the appropriate pediatric dosage and evaluate the pharmacokinetics (PK) and safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as a monotherapy or following…
- Conditions
- Somatostatin Receptor Positive, NETs, Lymphoma, Solid Tumor
- Trial name
- KinLET (NCT06441331)
- Testing
- Lutetium Lu 177-Edotreotide, Amino Acid Solution
- Where
- 9 sites in United States, France and 1 more
- Volunteers
- 20 people
- Sponsor
- ITM Solucin GmbH
Urinary Bladder, Overactive
A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug
Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults.
- Trial name
- LION (NCT01565707)
- Testing
- Solifenacin Succinate Suspension, Urotherapy
- Where
- 46 sites in United States, Belgium and 14 more
- Volunteers
- 189 people
- Sponsor
- Astellas Pharma Europe B.V.
Growth Hormone Deficiency, Pediatric, hGH (Human Growth Hormone)
A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
A 52 week trial of TransCon hGH, a long-acting growth hormone product, versus human growth hormone therapy. TransCon hGH will be given once-a-week, human growth hormone (hGH) will be given daily.
- Conditions
- Growth Hormone Deficiency, Pediatric, hGH (Human Growth Hormone), Endocrine System Diseases, Hormones
- Trial name
- NCT02781727
- Testing
- Once weekly subcutaneous injection of TransCon hGH, Once daily subcutaneous injection of Genotropin
- Where
- 53 sites in United States, Armenia and 12 more
- Volunteers
- 162 people
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
Hyperammonemia, Methylmalonic Acidemia
An Observational Study of Carbaglu® for the Treatment of MMA and PA in Adults and Pediatrics
To obtain short-term and long-term clinical safety information, in pediatric and adult patients with PA and MMA treated with Carbaglu®.
- Conditions
- Hyperammonemia, Methylmalonic Acidemia, Propionic Acidemia
- Trial name
- NCT05040178
- Testing
- Carglumic Acid
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- RECORDATI GROUP
Influenza
A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine in a Pediatric Population
The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus Vaccine in a pediatric population aged greater than or…
- Trial name
- NCT00959049
- Testing
- CSL's Influenza Virus Vaccine (Afluria), Influenza Virus Vaccine (Fluzone)
- Where
- 23 sites in United States
- Volunteers
- 1,474 people, healthy volunteers welcome
- Sponsor
- Seqirus
Metachromatic Leukodystrophy (MLD)
A Study to Learn About Metachromatic Leukodystrophy (MLD) in Children in Spain
The main aim of this study is to learn about metachromatic leukodystrophy (MLD) in children and teenagers in Spain. This includes checking the number of new MLD cases and the frequency of children with MLD in 2022 in Spain.
- Trial name
- mECHromatic (NCT05755568)
- Testing
- No Intervention
- Where
- 10 sites in Spain
- Sponsor
- Takeda
Allergic Rhinoconjunctivitis, Birch Pollen Allergy
Safety and Efficacy of STALORAL® Birch 300 IR in a Paediatric Population With Birch Pollen-induced ARC w/o Asthma
Allergic rhinoconjunctivitis due to birch pollen is a seasonal problem which manifests as a combination of nasal symptoms (such as congestion, runny nose, sneezing, itching of the nose) and ocular symptoms (such as red, itchy and…
- Trial name
- YOBI (NCT05668390)
- Testing
- STALORAL® Birch 300 IR
- Where
- 62 sites in Austria, Bulgaria and 10 more
- Volunteers
- 553 people
- Sponsor
- Stallergenes Greer
Asthma
Pediatric Study to Evaluate Treatment of Persistent Moderate or Severe Asthma With the Association Fluticasone 250 mcg/Dose and Salmeterol 50 mcg/Dose - ADERE PROJECT
Prospective, parallel-group, randomized study to evaluate the compliance to the treatment of children aged between 6 and 14 years old with persistent moderate or severe asthma, receiving the association Fluticasone 250 mcg/dose…
- Trial name
- ADERE (Ped) (NCT01476059)
- Testing
- Telephone follow-up, No telephone follow-up
- Volunteers
- 472 people
- Sponsor
- GlaxoSmithKline
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
Fragile X Syndrome
A Study of RO4917523 in Pediatric Patients With Fragile X Syndrome
This randomized, double-blind, placebo-controlled, parallel-arm study will evaluate the safety and exploratory efficacy and pharmacokinetics of RO4917523 in pediatric patients with fragile X syndrome.
- Trial name
- NCT01750957
- Testing
- RO4917523
- Where
- 20 sites in United States
- Volunteers
- 47 people
- Sponsor
- Hoffmann-La Roche
Japanese Encephalitis
Open-label, Randomized Study in a Pediatric Population in a JEV (Japanese Encephalitis Virus)-Endemic Country
This is a randomized, open-label Phase 3 study including children aged >9 months to <17 years and 7 months who have been vaccinated with IXIARO in study IC51-323.
- Trial name
- NCT01296360
- Testing
- IXIARO
- Where
- 3 sites in Philippines
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Valneva Austria GmbH
FLT3-mutated Acute Myeloid Leukemia
A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML
This study will evaluate the safety, efficacy and pharmacokinetics of midostaurin in combination with standard chemotherapy in pediatrics patients with newly diagnosed FLT3-mutated Acute Myeloid Leukemia.
- Trial name
- NCT03591510
- Testing
- Midostaurin, Fludarabine, Cytarabine
- Where
- 15 sites in Czechia, Germany and 8 more
- Volunteers
- 22 people
- Sponsor
- Novartis Pharmaceuticals
Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis
Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS
The primary objective of this study is to demonstrate equivalence of the pharmacokinetic (PK) profile of MSB11022 administered by either an auto-injector (AI) or a pre-filled syringe (PFS) as single subcutaneous (s.c.) injection…
- Conditions
- Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
- Trial name
- NCT04018599
- Testing
- 40 mg MSB11022
- Where
- 2 sites in United States
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- Fresenius Kabi SwissBioSim GmbH
Attention Deficit Hyperactivity Disorder, Attention Deficit Disorders With Hyperactivity
A Study to Evaluate Pharmacokinetics, Safety and Tolerability After a Single Dose Administration of of JNJ-31001074 in Children (6-11 Years) With Attention Deficit Hyperactivity Disorder (ADHD)
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the body) after a single dose of JNJ-31001074.
- Trial name
- NCT00890240
- Testing
- JNJ-31001074
- Volunteers
- 18 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Uncomplicated Plasmodium Falciparum Malaria
Efficacy, Safety and Tolerability of KAF156 in Combination With Lumefantrine Solid Dispersion Formulation (LUM-SDF) in Pediatric Population With Uncomplicated Plasmodium Falciparum Malaria
This study aimed to determine the efficacy, safety and tolerability of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in pediatric patients (6 months to < 18 years of…
- Trial name
- KALUMI (NCT04546633)
- Testing
- KAF156, LUM-SDF, Coartem
- Where
- 9 sites in Burkina Faso, Côte d’Ivoire and 3 more
- Volunteers
- 295 people
- Sponsor
- Novartis Pharmaceuticals
Atopic Dermatitis
Study Comparing Product 0405 to a Vehicle Control in the Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Subjects
The purpose of this study is to evaluate the safety and efficacy of product 0405 in pediatric subjects with Mild to Moderate Atopic Dermatitis.
- Trial name
- NCT02176538
- Testing
- Product 0405
- Sponsor
- Fougera Pharmaceuticals Inc.
Anemia of Chronic Kidney Disease
Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents
This study will assess the safety and efficacy of once daily dosing of vadadustat for the treatment of pediatric participants with anemia of chronic kidney disease (CKD) naive to erythropoiesis-stimulating agent (ESA) treatment.
- Trial name
- CORRECTION (NCT05082584)
- Testing
- Vadadustat
- Where
- United States
- Sponsor
- Akebia Therapeutics
Rhinitis, Allergic, Perennial
Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study.
The primary objective of this study is to characterize, as accurately as possible, the estimation of the difference in pre-pubescent growth velocities between subjects treated continuously for one year with FFNS 110mcg QD, the…
- Trial name
- NCT00570492
- Testing
- Fluticasone furoate nasal spray
- Where
- 74 sites in United States, Argentina and 5 more
- Volunteers
- 474 people
- Sponsor
- GlaxoSmithKline