Clinical trials: Paediatrics
Acute Lymphoblastic Leukaemias (ALL), Acute Myeloid Leukaemias (AML)
Treosulfan-based Conditioning in Paediatric Patients With Haematological Malignancies
The primary goal of this study is to evaluate an alternative myeloablative, but reduced toxicity conditioning regimen in children, to describe the safety and efficacy of intravenous (i.v.) Treosulfan administered as part of a…
- Conditions
- Acute Lymphoblastic Leukaemias (ALL), Acute Myeloid Leukaemias (AML), Myelodysplastic Syndromes (MDS), Juvenile Myelomonocytic Leukaemias (JMML)
- Trial name
- NCT02333058
- Testing
- Treosulfan
- Where
- 24 sites in Austria, Czechia and 4 more
- Volunteers
- 70 people
- Sponsor
- medac GmbH
Fibrodysplasia Ossificans Progressiva
A Study to Assess the Effectiveness and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP).
Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by the presence of bone in soft tissue where bone normally does not exist, known as Heterotopic Ossification (HO).
- Trial name
- FALKON (NCT05039515)
- Testing
- IPN60130
- Where
- 25 sites in United States, Argentina and 12 more
- Volunteers
- 113 people
- Sponsor
- Clementia Pharmaceuticals Inc.
Herpes Zoster
A Study to Test GlaxoSmithKline's (GSK) Candidate Vaccine-GSK1437173A for Prevention of Shingles in Children With Kidney Transplant
The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of 2 doses of PED-HZ/su, GSK's vaccine candidate for the prevention of Herpes Zoster (HZ) in immunocompromised paediatric renal transplant…
- Trial name
- NCT04006808
- Testing
- PED-HZ/su
- Where
- 31 sites in Belgium, France and 4 more
- Volunteers
- 184 people
- Sponsor
- GlaxoSmithKline
Gastroesophageal Reflux
Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole in Pediatric Subjects With Symptomatic Gastroesophageal Reflux Disease
The purpose of this study is to assess the pharmacokinetics and safety of dexlansoprazole, once daily (QD), in pediatric subjects with symptomatic Gastroesophageal Reflux Disease.
- Trial name
- NCT01045096
- Testing
- Dexlansoprazole
- Where
- 4 sites in United States
- Volunteers
- 36 people
- Sponsor
- Takeda
Central Precocious Puberty
A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty.
The purpose of the protocol is to assess the efficacy of the triptorelin 6 month PR (Prolonged Release) formulation in suppressing LH (Luteinising hormone) levels to prepubertal levels (defined as a peak LH ≤5 IU/L) after i.v.
- Trial name
- NCT05029622
- Testing
- Triptorelin Pamoate
- Where
- 14 sites in China
- Volunteers
- 66 people
- Sponsor
- Ipsen
Sickle Cell Disease
A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease
The purpose of this study is to determine the correct prasugrel dosage to be given to children with sickle cell disease (SCD).
- Trial name
- Crescent (NCT01476696)
- Testing
- Prasugrel
- Where
- 9 sites in United States
- Volunteers
- 33 people
- Sponsor
- Eli Lilly and Company
Cancer
Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations
This was a 4-part (Part A, Part B, Part C and Part D), Phase I/IIa, multi-center, open label, study in pediatric subjects with refractory or recurrent tumors.
- Trial name
- NCT02124772
- Testing
- Trametinib, Dabrafenib
- Where
- 16 sites in United States, Australia and 3 more
- Volunteers
- 139 people
- Sponsor
- Novartis Pharmaceuticals
Respiratory Syncytial Virus (RSV), Lower Resp Tract Infection
A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection.
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (sisunatovir). Sisunatovir is developed as potential treatment of Respiratory Syncytial Virus (RSV) infections.
- Trial name
- REVIRAL 1 (NCT04225897)
- Testing
- RV521
- Where
- 60 sites in Argentina, Canada and 13 more
- Volunteers
- 51 people
- Sponsor
- Pfizer
Infectious Diseases
BAY 0 9867 Cipro Pediatric Use Study (QUIP)
Objective and subjective musculoskeletal evaluations will be performed to determine differences in the ciprofloxacin versus non-quinolone treated pediatric patients so that we can tell what the natural occurrence of such…
- Trial name
- NCT00761462
- Testing
- Ciprofloxacin, Non-quinolone antibiotic
- Where
- 67 sites in United States, Canada
- Volunteers
- 1,029 people
- Sponsor
- Bayer
B-Cell Pediatric ALL
Study in Pediatrics With Relapsed or Refractory Pediatric Acute Lymphoblastic Leukemia (pALL) or Lymphoblastic Lymphoma
The primary objective of this study is to evaluate the efficacy of moxetumomab pasudotox in pediatric participants with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) or B-cell lymphoblastic lymphoma.
- Trial name
- NCT02227108
- Testing
- Moxetumomab Pasudotox
- Where
- 21 sites in United States, Australia and 6 more
- Volunteers
- 37 people
- Sponsor
- MedImmune LLC
Schizophrenia, Bipolar Disorder
A Study to Evaluate the Safety and the Effects of Risperidone Compared With Other Atypical Antipsychotic Drugs on the Growth and Sexual Maturation in Children
The purpose of this study is to evaluate the effects of risperidone compared with other atypical antipsychotic drugs on the physical maturity, growth and development of children, and the risk of prolactin-related adverse events…
- Conditions
- Schizophrenia, Bipolar Disorder, Autistic Disorder, Conduct and Other Disruptive Behavior Disorders
- Trial name
- NCT01050582
- Testing
- Risperidone, Other atypical antipsychotic drugs
- Where
- 28 sites in United States, Belgium and 4 more
- Volunteers
- 244 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Common Cold, Nasal Congestion
Two Seawater-based Formulations for Relief of Nasal Congestion in Paediatric Subjects
The objective of this clinical trial is to evaluate the tolerance and efficacy of two Stérimar nasal sprays products in children who have nasal congestion due to the common cold.
- Trial name
- NCT05244148
- Testing
- IP1 - Stérimar BLOCKED NOSE Baby nasal spray, IP2 - Stérimar Stop & Protect Cold Baby + standard of care, Standard of Care
- Where
- Italy
- Volunteers
- 9 people
- Sponsor
- Church & Dwight Company, Inc.
Sickle Cell Disease
Study to Evaluate the Effect of GBT440 in Pediatrics With Sickle Cell Disease
This study consists of four parts, Parts A, B, C, and D. Part A is a single dose pharmacokinetic (PK) study in pediatric participants with Sickle Cell Disease ages 6 to 17 years.
- Trial name
- HOPE-KIDS (NCT02850406)
- Testing
- Voxelotor
- Where
- 20 sites in United States, Lebanon and 1 more
- Volunteers
- 147 people
- Sponsor
- Pfizer
Neoplasms
Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Participants With Solid Tumors (SCOOP)
This study will evaluate the combination of a poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor, niraparib, with the programmed cell death protein 1 (PD-1) inhibitor, dostarlimab in the paediatric population.
- Trial name
- NCT04544995
- Testing
- Niraparib (Tablet for oral suspension), Dostarlimab, Niraparib (Tablet)
- Where
- 2 sites in United Kingdom
- Volunteers
- 47 people
- Sponsor
- GlaxoSmithKline
Constipation - Functional
Lubiprostone in Children With Functional Constipation
Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.
- Trial name
- NCT02042183
- Testing
- Lubiprostone
- Where
- 117 sites in United States, Belgium and 5 more
- Volunteers
- 606 people
- Sponsor
- Sucampo Pharma Americas, LLC
Primary Immunodeficiencies (PID)
Retrospective, Observational Chart Review Study Conducted in Poland to Document the Management and Clinical Outcome of CUVITRU and HYQVIA in Pediatric Participants (< 18 Years) With Primary Immunodeficiency (PID)
The purpose of this observational, multi-center, retrospective cohort study is to assess treatment patterns of Cuvitru (SCIG) 20 percent (%) and HyQvia (fSCIG) in polish pediatric participants with PID.
- Trial name
- IG-TATRY (NCT04636502)
- Where
- 5 sites in Poland
- Volunteers
- 96 people
- Sponsor
- Shire
Kidney Transplantation, Heart Transplantation
A Study to Determine Pharmacokinetics of Children Receiving Modigraf (Tacrolimus Granules) Following Solid Organ Transplantation
The purpose of this study is to find out how much of Modigraf is absorbed and used in the body and how fast it leaves the body (Pharmacokinetics).
- Conditions
- Kidney Transplantation, Heart Transplantation, Liver Transplantation
- Trial name
- OPTION (NCT01371331)
- Testing
- Tacrolimus granules
- Where
- 10 sites in Belgium, France and 4 more
- Volunteers
- 52 people
- Sponsor
- Astellas Pharma Europe Ltd.
Glaucoma, Ocular Hypertension
A Phase 1, Open-Label Study of Latanoprost Acid Plasma Concentrations in Pediatric and Adult Glaucoma Patients Treated With Latanoprost.
To evaluate the steady-state systemic plasma concentrations of latanoprost acid following administration of latanoprost 0.005% (1.5 ug) in pediatric and adult subjects with glaucoma or ocular hypertension.
- Trial name
- NCT00638742
- Testing
- latanoprost
- Where
- 13 sites in United States, Denmark and 4 more
- Volunteers
- 47 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Impetigo
Fucidin® Cream in the Treatment of Impetigo
To investigate the clinical and bacteriological efficacy of Fucidin® cream in the treatment of impetigo in paediatric patients. To assess the validity of in vitro susceptibility-testing of S.
- Trial name
- NCT00986856
- Testing
- Fucidin® cream
- Where
- 2 sites in Norway, Sweden
- Volunteers
- 58 people
- Sponsor
- LEO Pharma
Respiratory Failure
Trilogy Comparison Study - Pediatrics
The objective of this study (Part II) will be to compare the performance of the Trilogy device and a conventional ventilator (participant's current device).
- Trial name
- NCT00810459
- Testing
- Trilogy Ventilator, Standard of Care
- Where
- Canada
- Volunteers
- 6 people
- Sponsor
- Philips Respironics