Clinical trials: Only Child
Pulmonary Arterial Hypertension
Investigational Trial to Evaluate Safety and Tolerability of Treprostinil in Children Diagnosed With PAH
The goal of this clinical trial is to evaluate safety and tolerability of preservative-free parenteral treprostinil in paediatric patients with PAH (PH Group 1) who are below 18 years of age.
- Trial name
- NCT06350032
- Testing
- preservative-free parenteral treprostinil
- Where
- 5 sites in Austria, France and 3 more
- Volunteers
- 20 people
- Sponsor
- AOP Orphan Pharmaceuticals AG
ADHD, Autism
Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders
A study to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages 6 to <13 years with CNS disorders.
- Conditions
- ADHD, Autism, Bipolar I Disorder, Conduct Disorder
- Trial name
- NCT03292848
- Testing
- Brexpiprazole
- Where
- 9 sites in United States
- Volunteers
- 24 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Acute Lymphocytic Leukaemia, Acute Myeloid Leukaemia Refractory
First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
This is an open-label, multicenter, Phase 1/Phase 2, dose escalation and dose expansion study to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-leukemic activity of SAR443579 in various hematological…
- Conditions
- Acute Lymphocytic Leukaemia, Acute Myeloid Leukaemia Refractory, Myelodysplastic Syndromes, Blastic Plasmacytoid Dendritic Cell Neoplasia
- Trial name
- NCT05086315
- Testing
- SAR443579
- Where
- 23 sites in United States, Australia and 3 more
- Volunteers
- 101 people
- Sponsor
- Sanofi
Hepatic Impairment
Pharmacokinetics Study of FIA586 in Participants With Mild and Moderate Hepatic Impairment
This is a Phase I study designed to characterize the pharmacokinetics (PK), safety, and tolerability of a single oral dose of FIA586 in participants with mild and moderate hepatic impairment (HI) compared to matched healthy…
- Trial name
- NCT04993157
- Testing
- FIA586
- Where
- 2 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Aortic Coarctation, Pulmonary Artery Stenosis
First-in-human Clinical Trial to Assess Safety and Efficacy of the CardiaZn Bioresorbable Stent in Children With Pulmonary Artery Stenosis and Aortic Coarctation
This study evaluates the safety and effectiveness of the CardiaZn stent, a novel bioresorbable stent designed specifically for infants and children with congenital cardiovascular conditions.
- Trial name
- Pediasorb (NCT07628101)
- Testing
- CardiaZn Bioresorbable Stent
- Volunteers
- 45 people
- Sponsor
- PediaStent LLC
Idiopathic Short Stature (ISS)
Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature
The present randomized trial was initially intended to study the benefits of a combined treatment with growth hormone (GH) and a gonadotropin-releasing hormone (GnRH) agonist for pubertal children with idiopathic short stature.
- Trial name
- Phoenix (NCT00355030)
- Testing
- somatropin, leuprorelin
- Where
- 19 sites in France, Netherlands
- Volunteers
- 91 people
- Sponsor
- Eli Lilly and Company
Acquired Immunodeficiency Syndrome
A Study of Single Dose Nevirapine (NVP) Combined With Combivir® for the Prevention of Mother to Child Transmission (pMTCT) - Treatment Options Preservation Study (TOPS)
To determine whether a regimen of single dose nevirapine combined with either 4 or 7 days of Combivir®, compared to a regimen of single dose nevirapine, for the prevention of mother to child transmission can reduce the rate of…
- Trial name
- NCT00144183
- Testing
- Nevirapine (NVP), Zidovudine (ZCV), 3TC
- Where
- 5 sites in South Africa
- Volunteers
- 407 people
- Sponsor
- Boehringer Ingelheim
Leukaemia, Lymphoblastic, Acute
Observational Study of Nelarabine in Children and Young Adults
This international, multicentre, single arm, phase IV study will assess the safety and efficacy of nelarabine in children and young adults with relapsed or refractory T-lineage acute lymphoblastic leukaemia (T-ALL) or…
- Trial name
- NCT00866671
- Testing
- nelarabine
- Where
- 31 sites in Denmark, France and 7 more
- Volunteers
- 28 people
- Sponsor
- GlaxoSmithKline
Hepatic Impairment
A Trial to Evaluate the Pharmacokinetics of ABL001 in Healthy and Hepatic Impaired Subjects
The main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child-Pugh classification) on the pharmacokinetics (PK) of ABL001 after a single oral dose.
- Trial name
- NCT02857868
- Testing
- ABL001
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Pain
A Study to Evaluate Ibuprofen (IBU) 62.5 mg and Acetaminophen (APAP) 125 mg/5 ml in an Oral Liquid Suspension Fixed-Dose Combination Product in Children Aged 6 to 11 Years
The purpose of this study will be to characterize the pharmacokinetic (PK) profile of the Fixed-Dose Combination (FDC) IBU 62.5 milligram (mg)/APAP 125 mg per 5 milliliter (mL) suspension in children 6 to 11 years of age…
- Trial name
- NCT07632274
- Testing
- Test Product
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- HALEON
Healthy
Pharmacokinetics of Nilotinib in Subjects With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function
This study will be a formal assessment of the impact of hepatic function impairment on the pharmacokinetics of nilotinib
- Trial name
- NCT00418626
- Testing
- Nilotinib
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Achondroplasia
A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children With Achondroplasia
To Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children with Achondroplasia
- Trial name
- NCT05353192
- Testing
- Recombinant human growth hormone
- Where
- China
- Volunteers
- 39 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Secondary Hyperparathyroidism
A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric participants between ≥ 2 to < 18 years of age, with chronic…
- Trial name
- NCT03969329
- Testing
- Etelcalcetide
- Where
- 23 sites in Belgium, Czechia and 10 more
- Volunteers
- 24 people
- Sponsor
- Amgen
Type 2 Diabetes Mellitus
PK Study of Dapagliflozin in Pediatric Subjects With T2DM
The primary purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin in pediatric subjects with type 2 diabetes mellitus (T2DM)
- Trial name
- NCT01525238
- Testing
- Dapagliflozin
- Where
- 17 sites in United States, Mexico
- Volunteers
- 53 people
- Sponsor
- AstraZeneca
Neoplasms
A Study of BXQ-350 in Children and Young Adults With Relapsed Solid Tumors
This study will evaluate the safety of BXQ-350 and determine the maximum tolerated dose (MTD) in children and young adults with relapsed solid tumors, including recurrent malignant brain tumors.
- Trial name
- KOURAGE (NCT03967093)
- Testing
- BXQ-350
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Bexion Pharmaceuticals, Inc.
Asthma
A Study of the Bronchodilator Effect of Formoterol Fumarate Used in Combination With Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P06476 AM2)
A study to compare the bronchodilatory effect of a single dose of Mometasone Furoate/Formoterol Fumarate (MF/F) pressurized metered dose inhaler (MDI) delivered with and without an AeroChamber Plus® with Flow-Vu® Anti-Static…
- Trial name
- NCT01258803
- Testing
- Formoterol Fumarate DPI, Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer, Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
- Volunteers
- 92 people
- Sponsor
- Organon and Co
Influenza
Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V
The study aims to evaluate the immunogenicity of a single full (0.5 mL) dose and a 0.25 mL 2-dose regime of Inflexal V in unprimed children aged 6 - <36 months, using the EMA guideline for the re-registration of the seasonal…
- Trial name
- NCT01229397
- Testing
- Inflexal V
- Where
- 2 sites in Italy
- Volunteers
- 205 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
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
Diphtheria, Tetanus
To Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years
The study objective is to assess the immunogenicity and safety of DTaP-IPV combination vaccine administered as a boosting dose to healthy 4 to 6-year-old children who received three doses of primary immunization against…
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- Aladdin (NCT04618640)
- Testing
- DTaP-IPV combination vaccine
- Where
- 26 sites in South Korea
- Volunteers
- 249 people, healthy volunteers welcome
- Sponsor
- Boryung Biopharma Co., Ltd.
Hypertension
Olmesartan Pediatric Pharmacokinetic (PK) Study
Determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with hypertension in ages 12 months - 16 years
- Trial name
- NCT00151814
- Testing
- Olmesartan medoxomil
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- Daiichi Sankyo