Clinical trials: Pediatric Disease
Asthma
Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.
Primary objective: To demonstrate the efficacy of ciclesonide, compared to placebo, at 80 μg twice daily (BID) or 40 μg BID for 12 weeks in patients with persistent asthma.
- Trial name
- NCT00392288
- Testing
- Ciclesonide
- Where
- 6 sites in United States, Hungary and 4 more
- Volunteers
- 528 people
- Sponsor
- AstraZeneca
Enterovirus Infections
A Study to Evaluate the Immunogenicity and Safety of EV71 Vaccine in Pediatric Subjects
The objectives of this study are to evaluate the immune response and safety profiles of two injections of EV71 vaccine administrated with or without adjuvant Al(OH)3 at 0.5-μg and 1-μg dose in children aged 3 to 6 years old and 2…
- Trial name
- NCT03268083
- Testing
- EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose), EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose), EV71 vaccine ([1 μg total protein ] per dose)
- Where
- 4 sites in Taiwan
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Enimmune Corporation
Crohn Disease
A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease
The purpose of study is to test the effect of an experimental medication GED-0301(mongersen) and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease.
- Trial name
- NCT02974322
- Testing
- GED-0301
- Where
- 311 sites in United States, Australia and 28 more
- Sponsor
- Celgene
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease
The primary objective of the study was to evaluate the safety and tolerability of cinacalcet after a single oral dose in children aged 28 days to less than 6 years with chronic kidney disease receiving dialysis.
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Secondary Hyperparathyroidism
- Trial name
- NCT01290029
- Testing
- Cinacalcet
- Where
- 10 sites in United States, Germany and 1 more
- Volunteers
- 14 people
- Sponsor
- Amgen
CAH - Congenital Adrenal Hyperplasia
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 (Crinecerfont) in Pediatric Participants With Congenital Adrenal Hyperplasia
This is a Phase 2, open-label, multiple-dose, study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-74788 (crinecerfont) in pediatric participants (14 to 17 years of age) with a…
- Trial name
- NCT04045145
- Testing
- Crinecerfont
- Where
- 6 sites in United States
- Volunteers
- 8 people
- Sponsor
- Neurocrine Biosciences
Sialorrhea
Efficacy and Safety Study of MYOBLOC in the Treatment of Sialorrhea in Pediatric Subjects
This study will evaluate the efficacy and safety of MYOBLOC for the treatment of chronic sialorrhea in pediatric subjects.
- Trial name
- NCT05097079
- Testing
- MYOBLOC Low Dose, MYOBLOC High Dose
- Sponsor
- Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC
Cataract in Child
FLACS in Pediatric Patients Using FEMTO LDV-Z8
This study is a single center prospective observational case series. The framework of this clinical investigation is post market clinical follow up of pediatric FLACS using the Femto LDV Z8.
- Trial name
- NCT05241756
- Testing
- FLACS using FEMTO LDV-Z8
- Where
- Belgium
- Volunteers
- 12 people
- Sponsor
- Ziemer Ophthalmic Systems AG
Growth Hormone Deficiency
Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial)
This is a multi-national trial. The goals of the trial are to study LUM-201 as a possible treatment for Pediatric Growth Hormone Deficiency (PGHD) and investigate a predictive enrichment marker (PEM) strategy to select subjects…
- Trial name
- OraGrowtH210 (NCT04614337)
- Testing
- LUM-201, rhGH Norditropin® pen (34 µg/kg)
- Where
- 43 sites in United States, Australia and 4 more
- Volunteers
- 104 people
- Sponsor
- Lumos Pharma
Hypertension
An Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age
The purpose of this study is to evaluate in a randomized, double-blind fashion, the long-term safety, tolerability and efficacy profile of aliskiren compared to the active comparator enalapril in children, 6 - 17 years old with…
- Trial name
- NCT01151410
- Testing
- Aliskiren, Enalapril
- Where
- 36 sites in United States, Guatemala and 5 more
- Volunteers
- 208 people
- Sponsor
- Novartis Pharmaceuticals
Alpha-Mannosidosis
Trial on Safety and Efficacy of Velmanase Alfa Treatment in Pediatric Patients With Alpha-Mannosidosis
The main objectives of the study are to evaluate safety and efficacy of repeated treatment with recombinant human alfa-mannosidase of patients with alfa-mannosidosis aged less than 6 years
- Trial name
- rhLaman-08 (NCT02998879)
- Testing
- Velmanase Alfa (e.g. Lamazym)
- Where
- 6 sites in Austria, Denmark and 3 more
- Volunteers
- 5 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Hyperphosphatemia Related to Chronic Kidney Disease
Study to Evaluate the Safety and Tolerability of Ferric Citrate in Children With Hyperphosphatemia Related to Chronic Kidney Disease
This study will be conducted to assess the safety and tolerability of ferric citrate in pediatric participants with hyperphosphatemia related to chronic kidney disease (CKD).
- Trial name
- NCT04523727
- Testing
- ferric citrate
- Where
- 14 sites in United States
- Volunteers
- 45 people
- Sponsor
- Keryx Biopharmaceuticals
Sarcoma, Neutropenia
Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy
Physicians are conducting a clinical trial for patients with pediatric sarcoma. Sarcoma is a type of bone cancer that can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced.
- Trial name
- NCT00035620
- Testing
- pegfilgrastim, filgrastim
- Volunteers
- 44 people
- Sponsor
- Amgen
Hemophilia A
Safety and Efficacy of BAY94-9027 in Previously Treated Male Children With Haemophilia A
Hemophilia A is an inherited blood disorder in which one protein, Factor VIII, needed to form blood clots is missing or not present in sufficient levels.
- Trial name
- NCT01775618
- Testing
- BAY94-9027
- Where
- 37 sites in United States, Argentina and 15 more
- Volunteers
- 73 people
- Sponsor
- Bayer
Infection, Human Immunodeficiency Virus, HIV Infections
Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects
This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to < 2 years…
- Trial name
- NCT00071760
- Testing
- GW433908, ritonavir
- Where
- 15 sites in United States, Argentina and 5 more
- Volunteers
- 59 people
- Sponsor
- ViiV Healthcare
Melanoma
A Study to Evaluate Treatment With Nivolumab Alone and Nivolumab Combined With Ipilimumab in Children With Melanoma
The purpose of this study is to describe real-world safety outcomes in children with melanoma who are treated with nivolumab alone or nivolumab in combination with ipilimumab for unresectable or metastatic melanoma, or treated…
- Trial name
- NCT06163170
- Testing
- Nivolumab +/- ipilimumab, Nivolumab
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Bristol-Myers Squibb
Cytomegalovirus (CMV) Infection
Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)
The primary objective of this study is to evaluate the pharmacokinetics (PK) of letermovir (LET) in pediatric participants. Participants will be enrolled in the following 3 age groups: Age Group 1: From 12 to <18 years of age…
- Trial name
- NCT03940586
- Testing
- Letermovir oral granules, Letermovir tablet, Letermovir intravenous
- Where
- 40 sites in United States, Australia and 9 more
- Volunteers
- 65 people
- Sponsor
- Merck Sharp & Dohme LLC
Bipolar Depression
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as…
- Trial name
- NCT06372964
- Testing
- Lumateperone
- Where
- 68 sites in United States, Colombia and 2 more
- Volunteers
- 384 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Migraine
AMG 334 20160172 Pediatric Migraine PK Study.
AMG 334 20160172 Pediatric Migraine PK Study.
- Trial name
- NCT03499119
- Testing
- AMG 334 Dose 1, AMG 334 Dose 2, AMG 334 Dose 3
- Where
- 14 sites in United States
- Volunteers
- 53 people
- Sponsor
- Amgen
Lupus Nephritis
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with…
- Trial name
- POSTERITY (NCT05039619)
- Testing
- Obinutuzumab, Mycophenolate Mofetil, Acetaminophen/paracetamol
- Where
- 44 sites in United States, Brazil and 10 more
- Volunteers
- 40 people
- Sponsor
- Hoffmann-La Roche
Acute Otitis Media (AOM), Strep Pharyngitis
Evaluation of the Medentum Diagnostik Platform for Pediatric ENT Conditions and Asthma
This study evaluates the diagnostic performance, usability, and clinical utility of the Medentum Diagnostik platform, a multisensor device with integrated software and artificial intelligence, in pediatric patients with asthma…
- Conditions
- Acute Otitis Media (AOM), Strep Pharyngitis, Asthma Exacerbation, Pediatric Asthma
- Trial name
- NCT07500532
- Testing
- Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of AOM and strep pharyngitis, Diagnostik home-based platform: multisensor device, software application, and artificial-intelligence algorithms that predict diagnosis of wheeze/asthma exacerbation, Routine Asthma Management (in-person and telehealth visits)- Control Group
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Medentum Innovations