Clinical trials: Pediatric Disease
Atopic Dermatitis
Use of a Mobile Health App in Managing Pediatric Atopic Dermatitis
A randomized controlled study in children with AD, divided into three groups: a control group without access to the app, an experimental observational group with the app, and an experimental interventional group with potential…
- Trial name
- NCT06412094
- Testing
- Standard care, Access to the "AtopicApp" mobile application, Virtual oversight through the AtopicApp
- Where
- Russia
- Volunteers
- 66 people
- Sponsor
- Avanta Trading Ltd.
Chronic Idiopathic Urticaria, Atopy
Safety of Desloratadine in Children With Allergy Sensitivity and Chronic Hives, Who Are Poor Metabolizers of Desloratadine (Study P02994)
This study was conducted to evaluate the safety and tolerance of desloratadine after 5 weeks of repetitive dosing in children ages 2 to 12 years old with allergic hypersensitivity or chronic hives.
- Trial name
- NCT00757562
- Testing
- desloratadine
- Volunteers
- 97 people
- Sponsor
- Organon and Co
Type 1 Diabetes, T1D
DASH-Obesity: Explainable AI for Family-Centric Personalized Weight Control in Adolescents and Young Adults With Obesity and Chronic Conditions
This prospective single-arm feasibility study evaluates the Adhera Caring Digital Program for Obesity (ACDP-O), a family-centered digital health intervention designed to support adolescents and young adults with…
- Conditions
- Type 1 Diabetes, T1D, Obesity & Overweight, Obesity Type 2 Diabetes Mellitus
- Trial name
- DASH-Obesity (NCT07638345)
- Testing
- Adhera Caring Digital Program-Obesity (ACDP-O)
- Where
- Spain
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Adhera Health, Inc.
Cystinosis
Cystadrops in Pediatric Cystinosis Patients From Six Months to Less Than Two Years Old (SCOB2)
Cystadrops® is currently indicated in adults and children from 2 years of age diagnosed with cystinosis with corneal crystal accumulation observed.
- Trial name
- SCOB2 (NCT04125927)
- Testing
- Mercaptamine
- Where
- 6 sites in Belgium, France and 3 more
- Volunteers
- 5 people
- Sponsor
- RECORDATI GROUP
Anemia
Iron Sucrose in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients
The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron Sucrose Injection) in NDD-CKD pediatric patients.
- Trial name
- NCT00721188
- Testing
- Venofer
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- American Regent, Inc.
HIV Infections
Dolutegravir Pediatric Liquid Formulation Study
This is an open-label, single-center, single dose, non-randomized, sequential, fixed-sequence study, which will evaluate pharmacokinetics (PK) of dolutegravir (DTG) in healthy adult subjects.
- Trial name
- NCT03921723
- Testing
- Dolutegravir dispersible tablet, Dolutegravir oral suspension, Dolutegravir oral solution
- Where
- United Kingdom
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Attention Deficit Hyperactivity Disorder
Dasotraline Pediatric ADHD Study
This is a 6 week efficacy and safety study of Dasotraline in subjects 6 to 12 years old with ADHD.
- Trial name
- NCT02428088
- Testing
- Dasotraline
- Where
- 43 sites in United States
- Volunteers
- 330 people
- Sponsor
- Sumitomo Pharma America, Inc.
Glycogen Storage Disease Type II Infantile Onset
A Study to Evaluate the Safety, Efficacy, PK, PD and Immunogenicity of Cipaglucosidase Alfa/Miglustat in IOPD Subjects Aged 0 to <18
This is a Phase 3, open-label, multicenter study to evaluate the safety, efficacy, PK, PD, and immunogenicity of cipaglucosidase alfa/miglustat treatment in ERT-experienced and ERT-naïve pediatric subjects with IOPD.
- Trial name
- ROSSELLA (NCT04808505)
- Testing
- Cipaglucosidase alfa, Miglustat
- Where
- 14 sites in United States, Germany and 4 more
- Volunteers
- 36 people
- Sponsor
- Amicus Therapeutics
Generalized Myasthenia Gravis, gMG
Evaluation of PK, PD, Efficacy, Safety, and Immunogenicity of IV Ravulizumab in Pediatric Participants With Generalized Myasthenia Gravis
The primary purpose of this study is to characterize the pharmacokinetics and pharmacodynamics of treatment with ravulizumab intravenous infusion in pediatric participants with gMG.
- Trial name
- NCT05644561
- Testing
- Ravulizumab
- Where
- 11 sites in United States, Italy and 3 more
- Volunteers
- 12 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Pneumococcal Disease
Pneumoniae Epidemiology Study in China
To determine the proportion of hospitalized pneumonia cases in children aged 60 months or less associated with vaccine-preventable Streptococcus pneumoniae serotypes (4, 6B, 9V, 14, 18C, 19F, 23F).
- Trial name
- NCT00471770
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Asthma
Pharmacokinetics and Pharmacodynamics of Mepolizumab Administered Subcutaneously in Children
Mepolizumab is a humanized immunoglobulin G (IgG1) monoclonal antibody (mAb) that exhibits dose proportional and time-independent pharmacokinetics. The study will be conducted in 2 parts.
- Trial name
- NCT02377427
- Testing
- Mepolizumab
- Where
- 16 sites in United States, Japan and 2 more
- Volunteers
- 36 people
- Sponsor
- GlaxoSmithKline
Recurrent Malignant Glioma
Phase I/II Trial of Intracerebral IL13-PE38QQR Infusions in Pediatric Patients With Recurrent Malignant Glioma
IL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a bacteria toxin). IL3-PE38QQR is a protein that exhibits cell killing activity against a variety of IL13-receptor positive tumor cell…
- Trial name
- NCT00378235
- Testing
- IL13-PE38QQR
- Where
- 10 sites in United States
- Sponsor
- INSYS Therapeutics Inc
Polycystic Kidney, Autosomal Recessive
A Safety, Pharmacokinetic, Single Ascending Dose Study of Tesevatinib in Pediatric Subjects With Autosomal Recessive Polycystic Kidney Disease (ARPKD)
This study evaluates safety and tolerability of a single ascending dose of a tesevatinib liquid formulation administered to pediatric subjects with ARPKD.
- Trial name
- NCT03096080
- Testing
- Tesevatinib
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Kadmon Corporation, LLC
Hunter Syndrome
Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter Syndrome
As the HGT-HIT-046 (NCT01506141) and SHP609-302 (NCT02412787) studies are completed and closed, this post-trial access (PTA) program provides TAK-609 to participants in these studies for whom the benefit:risk ratio of continued…
- Trial name
- NCT05795361
- Testing
- Idursulfase-IT
- Where
- 22 sites in United States, Australia and 3 more
- Sponsor
- Takeda
Attention Deficit Hyperactivity Disorder (ADHD)
A Long Term Post-Marketing Study on the EffIcacy and Safety of Osmotic Release Oral System (OROS) Methylphenidate on the Cognitive Functions of Attention Deficit Hyperactivity Disorder (ADHD) Participants
The purpose of this long term post-marketing study is to evaluate the effectiveness and safety of osmotic release oral system methylphenidate hydrochloride (OROS-MPH) in participants with Attention Deficit Hyperactivity Disorder…
- Trial name
- NCT01933880
- Testing
- Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH), No intervention
- Where
- 6 sites in China
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- Xian-Janssen Pharmaceutical Ltd.
Migraine
Efficacy & Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE
To evaluate the efficacy and safety of zolmitriptan nasal spray (ZNS) in the acute treatment of migraine headache in subjects ages 6 to 11 years. Part 1: Approximately 20 weeks (includes screening and double-blind treatment).
- Trial name
- NCT03275922
- Testing
- ZNS
- Where
- 47 sites in United States
- Volunteers
- 374 people
- Sponsor
- Impax Laboratories, LLC
Chronic Hepatitis B
Pharmacokinetics and Safety of Single-Dose Telbivudine in Children and Adolescents With Chronic Hepatitis B
This is a Phase I, open-label, single-dose study to evaluate the pharmacokinetics and safety of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection.
- Trial name
- NCT00907894
- Testing
- LDT600 (Telbivudine)
- Where
- 7 sites in Belgium, Germany and 2 more
- Volunteers
- 22 people
- Sponsor
- Novartis Pharmaceuticals
Gram-negative Bacterial Infections, Bloodstream Infections (BSI)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants
The primary objectives of this study are: To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric participants 3 months to < 18 years of age with suspected or confirmed…
- Conditions
- Gram-negative Bacterial Infections, Bloodstream Infections (BSI), Complicated Intra-abdominal Infection (cIAI), Hospital Acquired Pneumonia (HAP)
- Trial name
- NCT04335539
- Testing
- Cefiderocol, Standard of Care
- Where
- 23 sites in Belgium, Estonia and 7 more
- Volunteers
- 53 people
- Sponsor
- Shionogi
Type 3 Gaucher Disease
Managed Access Program of Venglustat in Pediatric and Adult Patients With Type 3 Gaucher Disease (GD3).
The objective of this program is to provide early access to venglustat for certain patients with Gaucher disease type 3 in response to unsolicited requests from healthcare providers.
- Trial name
- NCT07675031
- Testing
- GZ402671
- Sponsor
- Sanofi
Familial Mediterranean Fever, FMF
Goflikicept for Resolution and Prevention of Attacks in Pediatric and Adolescent Patients With Colchicine-Resistant or Colchicine-Intolerant Familial Mediterranean Fever
The primary objective is to evaluate the main pharmacokinetic (PK) parameters, efficacy, and safety of goflikicept (GFC) in children and adolescents with colchicine-resistant or colchicine-intolerant familial Mediterranean fever…
- Trial name
- NCT07880886
- Testing
- RPH-104
- Where
- 3 sites in Russia
- Volunteers
- 18 people
- Sponsor
- R-Pharm
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