Clinical trials: Pediatric Safety and Effectiveness
Sialorrhea, Neurodevelopmental Disorders
Double-blind, Placebo-controlled, Randomized Clinical Trial Comparing the Efficacy and Safety of Sialanar Plus orAl rehabiLitation Against Placebo Plus Oral Rehabilitation for chIldren and Adolescents With seVere Sialorrhoea and Neurodisabilties,
Double blind, placebo-controlled, randomised trial, multicentre in France with open-label tolerability phase. The double-blind placebo-controlled study duration will be scheduled for 3 months with the final visit of the…
- Trial name
- SALIVA (NCT04873115)
- Testing
- Sialanar, Oral Rehabilitation
- Where
- France
- Volunteers
- 80 people
- Sponsor
- Proveca Pharma Limited
Status Asthmaticus
Early Noninvasive Positive Pressure Ventilation in Children With Status Asthmaticus
Status asthmaticus is recognized as a common cause of morbidity in children in the United States. In recent years, hospitalization rates have reached an all time high.
- Trial name
- NCT01188473
- Testing
- NPPV plus standard of care
- Where
- United States
- Sponsor
- Southern Illinois University
IgAVN, IgA Vasculitis
Telitacicept in the Treatment of Pediatric IgA Vasculitis-Associated Nephritis
To further evaluate the efficacy and safety of Telitacicept in the treatment of pediatric IgA vasculitis nephritis (IgAVN) within real-world settings, this study employs a multicenter, retrospective and prospective observational…
- Trial name
- NCT07354503
- Testing
- Collect clinical data from the patients., This study exclusively prospectively collected clinical data from the patients and did not involve any therapeutic interventions
- Volunteers
- 300 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Hypertension
Efficacy, Safety, & Pharmacokinetics of Candesartan Cilexetil in Hypertensive Paediatric Subjects 6 to < 17 Years of Age
The objectives of this study are to describe candesartan cilexetil antihypertensive effects in terms of achieved blood pressure and hypertension control rates and the relationship between subject characteristics and…
- Trial name
- NCT00244595
- Testing
- candsartan cilexetil
- Where
- 44 sites in United States, Belgium and 2 more
- Volunteers
- 235 people
- Sponsor
- AstraZeneca
Equinus Contracture
A Needle Technique for Achilles Tendon Lengthening in Pediatric Patients: A Prospective Study on Efficacy, Safety, and Feasibility
For years, we have used a minimally invasive and biological variant of Achilles tendon lengthening using a needle inserted into the Achilles tendon so that it is weakened and can be gradually stretched to the desired length.
- Trial name
- NCT06912061
- Testing
- Needle tendon lengthening technique
- Where
- Norway
- Volunteers
- 50 people
- Sponsor
- Vestre Viken Hospital Trust
Pain, Postoperative, Developmental Dislocation of Hip
Efficacy and Safety of Quadratus Lumborum Block Versus Pericapsular Nerve Group Block in Pediatric Hip Surgery
Surgical procedure including hip joint surgery is extremely painful and associated with considerable postoperative pain in children despite the use of systemic opioids.
- Trial name
- TQL (NCT05349656)
- Testing
- TQL block, PENG block
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Alexandria University
Crohn's Disease
A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD)
This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in pediatric patients with moderately to severely active CD who are treated as recommended in the local product label.
- Trial name
- CAPE (NCT02130362)
- Where
- 148 sites in United States, Bosnia and Herzegovina and 20 more
- Volunteers
- 1,446 people
- Sponsor
- AbbVie
Infections, Pediatrics
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections
This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil in children with skin infections receiving antibiotic therapy in the hospital.
- Trial name
- NCT01400867
- Testing
- Ceftaroline fosamil, Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam, Cephalexin or Clindamycin or Linezolid
- Where
- 71 sites in United States, Argentina and 8 more
- Volunteers
- 163 people
- Sponsor
- Forest Laboratories
Relapse B Acute Lymphoblastic Leukemia, Refactory Childhood Acute Lymphoblastic Leukemia
Clinical Trial of CMD63 Chimeric Antigen Receptor T-cell (CAR T-cell) in Children With Acute Lymphoblastic Leukemia (ALL)
A Phase 1 clinical trial to evaluate the safety and early efficacy of Chimeric Antigen Receptor T-cell (CAR T-cell) with IL-7Rα signaling targeting CD19 in children with relapsed and refractory B-cell Acute Lymphoblastic Leukemia…
- Trial name
- CMD63 (NCT07078929)
- Testing
- CD19-IL7Ra CAR-T cells
- Where
- 3 sites in Thailand
- Volunteers
- 16 people
- Sponsor
- Chulalongkorn University
Evidence of Liver Transplantation, Rejection
Safety and Efficacy of Alemtuzumab in Pediatric Intestinal Transplantation
This open-label clinical trial will evaluate the safety and efficacy of Alemtuzumab (Campath, Bayer Corp., Pittsburgh) in children (0-17) and adults (18-25) receiving intestinal transplant.
- Conditions
- Evidence of Liver Transplantation, Rejection, ALEMTUZUMAB
- Trial name
- NCT01208337
- Testing
- Alemtuzumab
- Volunteers
- 23 people
- Sponsor
- University of Pittsburgh
Asthma
A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma
A Safety, Efficacy, and Tolerability Study of Daily Dosing with Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to <48 Months with Asthma.
- Trial name
- NCT00809757
- Testing
- Levalbuterol, Levalbuterol UDV TID
- Where
- 46 sites in United States
- Volunteers
- 197 people
- Sponsor
- Sumitomo Pharma America, Inc.
Pediatric Cholestasis
A4250, an IBAT Inhibitor in Pediatric Cholestasis
This study will evaluate A4250 (IBATinhibitor) as a treatment option in pediatric patients with chronic cholestasis with main emphasis on safety evaluation and on effects on pruritus
- Trial name
- NCT02630875
- Testing
- A4250
- Where
- 7 sites in Denmark, France and 3 more
- Volunteers
- 24 people
- Sponsor
- Albireo
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
Plaque Psoriasis
A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis
The main aim of this study is to see how well the medicine zasocitinib works, how safe it is, and how children and teenagers aged 4 to under 18 with moderate-to-severe plaque psoriasis respond to it.
- Trial name
- NCT07250802
- Testing
- Zasocitinib
- Where
- 39 sites in United States, China and 5 more
- Volunteers
- 110 people
- Sponsor
- Takeda
Newly Diagnosed Pediatric ITP
Safety, Tolerability and Efficacy of Single Dose Low Cost Minipool Intravenous Immunoglobulins in Moderately Severe Newly Diagnosed ITP
To demonstrate the efficacy of new product IVIG prepared by minipool technology as assessed by Bleeding Score and platelet count at 3 days, 1 week, 2 weeks and 4 weeks.
- Trial name
- NCT02669277
- Testing
- IVIG prepared by minipool technology, standard IVIG product
- Where
- Egypt
- Volunteers
- 72 people
- Sponsor
- Ain Shams University
Molluscum Contagiosum
A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of Molluscum Contagiosum
This trial will examine the safety, tolerability and efficacy of one strength of East Indian sandalwood oil (EISO) in a cream base compared to a placebo for treatment of molluscum contagiosum in pediatric subjects.
- Trial name
- NCT02024581
- Testing
- 10% East Indian sandalwood oil cream
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- ViroXis Corporation
Allergic Asthma
Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Omalizumab in Japanese Children (6 - 15 Years)
The primary purpose of this study is to examine whether the geometric mean of serum free IgE level at 24 weeks of the treatment period in Japanese pediatric patients (6 to 15 years of age) reaches under 25 ng/mL (target level).
- Trial name
- NCT01155700
- Testing
- omalizumab
- Where
- 17 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Novartis Pharmaceuticals
Anemia of Chronic Kidney Disease
Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease
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) after conversion from an Erythropoiesis Stimulating Agent…
- Trial name
- CONVERSION (NCT05082571)
- Testing
- vadadustat
- Where
- United States
- Sponsor
- Akebia Therapeutics
Beta-Thalassemia, Thalassemia
Evaluation of Safety and Efficacy of CTX001 in Pediatric Participants With Transfusion-Dependent β-Thalassemia (TDT)
This is a single-dose, open-label study in pediatric participants with TDT. The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (CTX001).
- Conditions
- Beta-Thalassemia, Thalassemia, Genetic Diseases, Inborn, Hematologic Diseases
- Trial name
- NCT05356195
- Testing
- CTX001
- Where
- 6 sites in United States, Canada and 3 more
- Volunteers
- 16 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Magnetic Resonance Imaging
DOTAREM Pharmacokinetics and Safety Study in Pediatric Subjects Aged < 2 Years
The main purpose of the study is to evaluate the pharmacokinetics of DOTAREM® in the body of children aged less than 2 years thanks to several blood samples (3 ml in total) taken following the administration of DOTAREM®.
- Trial name
- NCT02411201
- Testing
- DOTAREM
- Where
- 9 sites in Austria, France and 2 more
- Volunteers
- 51 people
- Sponsor
- Guerbet
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