Clinical trials: Pediatric Safety and Effectiveness
Hodgkin Lymphoma, Adult, Hodgkin Disease Recurrent
Phase 2 Study Evaluating Autologous CD30.CAR-T Cells in Patients With Relapsed/Refractory Hodgkin Lymphoma (CHARIOT)
This is a two-part, Phase 2, multicenter, open-label, single arm study to evaluate the safety and efficacy of autologous CD30.CAR-T in adult and pediatric subjects with relapsed or refractory CD30+ classical Hodgkin Lymphoma.
- Conditions
- Hodgkin Lymphoma, Adult, Hodgkin Disease Recurrent, Hodgkin Disease Refractory, Hodgkin Disease, Pediatric
- Trial name
- NCT04268706
- Testing
- CD30.CAR-T, Fludarabine, Bendamustine
- Where
- 5 sites in United States
- Volunteers
- 97 people
- Sponsor
- Tessa Therapeutics
Thrombotic Microangiopathies, Hematopoietic Stem Cell Transplantation
Efficacy and Safety Study of Narsoplimab in Pediatric Patients With High-Risk Hematopoietic Stem Cell Transplant TMA
The purpose of this study is to evaluate the safety and efficacy of narsoplimab in pediatric patients with thrombotic microangiopathies (TMA) following hematopoietic stem cell transplant (HSCT).
- Trial name
- NCT05855083
- Testing
- Biological: narsoplimab
- Where
- 16 sites in United States, Germany and 3 more
- Volunteers
- 18 people
- Sponsor
- Omeros Corporation
Burns
RES® Prepared With RECELL® Compared to Standard of Care Dressings of Partial-thickness Burns in Ages 1-16 Years
A prospective, parallel-arm, randomized (1:1) multicenter trial to demonstrate that RECELL treatment of partial-thickness burn injuries, can safely and effectively increase the incidence of Day 10 healing compared with a…
- Trial name
- NCT03626701
- Testing
- RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device, Mepilex® Ag Wound Dressing, Conventional autografting (only when indicated)
- Where
- 9 sites in United States
- Volunteers
- 19 people
- Sponsor
- Avita Medical
Rheumatic Diseases, Pediatric Rheumatological Condition (i.e., Arthritis, SLE, Kawasaki's Disaese)
Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA CAR-NK Cell Injection for the Treatment of Refractory Pediatric Rheumatic Diseases
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA CAR-NK cell injection in patients with refractory pediatric rheumatic diseases.
- Conditions
- Rheumatic Diseases, Pediatric Rheumatological Condition (i.e., Arthritis, SLE, Kawasaki's Disaese), Systemic Lupus Erythematosus (SLE), Connective Tissue Disease-associated Interstitial Lung Disease
- Trial name
- Cell therapy (NCT07490041)
- Testing
- KN5601
- Where
- China
- Volunteers
- 36 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Steroid-Sensitive Nephrotic Syndrome
Efficacy and Safety of Rituximab in the First Episode of Pediatric Idiopathic Nephrotic Syndrome
The main objective is to demonstrate, from the initial episode of nephrotic syndrome (NS) in children with standard prednisolone treatment, once complete remission has occurred, that the use of Rituximab (a single intravenous…
- Trial name
- RTXFIRPedINS (NCT04783675)
- Testing
- Rituximab
- Where
- 8 sites in China
- Volunteers
- 44 people
- Sponsor
- Children's Hospital of Fudan University
Short Bowel Syndrome
Characterization of the Long-term Safety, Efficacy, and Pharmacodynamics Revestive® in the Management of Short Bowel Syndrome Pediatric Patients
The purpose of this study is to evaluate if the treatment could maximize intestinal absorption, minimize the inconvenience of diarrhea, and avoid, reduce or eliminate the need for parenteral support (PS) to achieve normal growth…
- Trial name
- REVE (NCT03562130)
- Testing
- Teduglutide
- Where
- France
- Volunteers
- 25 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Tinea Capitis
Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules and pruritus are the primary clinical signs…
- Trial name
- NCT00117767
- Testing
- Terbinafine hydrochloride (HCl), Griseofulvin
- Where
- United States
- Volunteers
- 720 people
- Sponsor
- Novartis Pharmaceuticals
Hypofibrinogenemia, Congenital, Afibrinogenemia, Congenital
Human Fibrinogen Concentrate (FGTW) in Pediatric Patients With Congenital Fibrinogen Deficiency
The aim of the study is to evaluate clinical pharmacology, efficacy and safety of FGTW in pediatric patients with congenital fibrinogen deficiency.
- Trial name
- NCT02094430
- Testing
- biological: human fibrinogen concentrate
- Where
- 4 sites in France, Lebanon and 2 more
- Volunteers
- 16 people
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Neurogenic Detrusor Overactivity
A Two-week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (2 - 15 Years) With Neurogenic Detrusor Overactivity
This study will evaluate the pharmacodynamics and pharmacokinetics of darifenacin liquid oral suspension in children, ages 2-15 years, with neurogenic detrusor overactivity.
- Trial name
- NCT00712322
- Testing
- Darifenacin
- Where
- 12 sites in United States, Colombia
- Volunteers
- 35 people
- Sponsor
- Warner Chilcott
Epilepsy With Partial-onset Seizures
Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures
The purpose of this trial is to assess the efficacy, safety and tolerability of lacosamide administered as add-on therapy with 1 to 3 anti-seizure medications.
- Trial name
- NCT02477839
- Testing
- Lacosamide
- Where
- 88 sites in United States, Argentina and 24 more
- Volunteers
- 255 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Ulcerative Colitis
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).
- Trial name
- NCT02065557
- Testing
- Adalimumab
- Where
- 60 sites in United States, Australia and 12 more
- Volunteers
- 101 people
- Sponsor
- AbbVie
Type 1 Diabetes Mellitus
Real-world Study on the Effectiveness and Safety of Control-IQ Technology in Teenagers With Type 1 Diabetes Engaging in Regular Physical Activity
We hypothesize that the use of the Control-IQ system positively influences glycemic control in teenagers with type 1 diabetes during physical activity.
- Trial name
- PED-CIQAcT1ve (NCT06876207)
- Testing
- Tandem t:slim X2 with Control-IQ technology
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Bruno Bombaci
BKV Infection, CMV Infection
Evaluation of Safety and Efficacy of Virus Specific T-Cell Administration in Pediatric Patients With Systemic Viral Infection Following Allogeneic Hematopoietic Stem Cell Transplantation.
The goal of this prospective clinical study is to evaluate the safety and efficacy of Multi-Virus Specific T cells (LB-DTK-MV) in pediatric patients with systemic viral infection, including CMV, EBV, and BKV, after allogeneic…
- Conditions
- BKV Infection, CMV Infection, EBV Infection
- Trial name
- NCT07685457
- Testing
- LB-DTK-MV
- Where
- South Korea
- Volunteers
- 6 people
- Sponsor
- LucasBio
Cerebral Palsy, Neurological Conditions
Safety and Efficacy Study of Oral Glycopyrrolate Liquid for the Treatment of Pathologic (Chronic Moderate to Severe) Drooling in Pediatric Patients 3 to 18 Years of Age With Cerebral Palsy or Other Neurologic Conditions
This is an open-label clinical research study of an oral glycopyrrolate liquid for the treatment of chronic moderate to severe drooling in patients with cerebral palsy or other neurological conditions.
- Conditions
- Cerebral Palsy, Neurological Conditions, Mental Retardation, Sialorrhea
- Trial name
- NCT00491894
- Testing
- Oral Glycopyrrolate Liquid
- Where
- 7 sites in United States
- Volunteers
- 137 people
- Sponsor
- Shionogi
Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial
Observation of Side Effects and Effectiveness of Desloratadine (Aerius) Syrup in Filipino Children (Study P05634)
The purpose of this study is to observe the side effects of desloratadine syrup and how effective it is in relieving symptoms of allergic rhinitis or hives in Filipino children.
- Conditions
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial, Urticaria
- Trial name
- NCT00761527
- Testing
- Desloratadine Syrup
- Volunteers
- 2,980 people
- Sponsor
- Organon and Co
B-cell Acute Lymphoblastic Leukemia, Acute Lymphocytic Leukemia, Pediatric
CD19 T-CAR for Treatment of Children and Young Adults With r/r B-ALL
The purpose of this study is to evaluate the safety and efficiency of autologous CD19 CAR-T lymphocytes in a cohort of pediatric and young adult patients with relapsed /refractory B-lineage acute lymphoblastic leukemia
- Trial name
- NCT03467256
- Testing
- Chimeric Antigen Receptor T-Cell Therapy, Fludarabine, Cyclophosphamide
- Where
- Russia
- Volunteers
- 18 people
- Sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Pediatric Migraine
Randomized Study in Children and Adolescents With Migraine: Acute Treatment
The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.
- Trial name
- NCT04649242
- Testing
- Rimegepant/BHV3000
- Where
- 246 sites in United States, Canada and 7 more
- Volunteers
- 2,100 people
- Sponsor
- Pfizer
Pompe Disease (Late-onset)
ZIP Study-OL Study of Safety, PK, Efficacy, PD, Immunogenicity of ATB200/AT2221 in Pediatrics Aged 0 to < 18 y.o. w/LOPD
This is a Phase 3, open-label, multicenter study to evaluate the safety, PK, efficacy, PD, and immunogenicity of Cipaglucosidase Alfa/Miglustat treatment in enzyme replacement therapy (ERT)-experienced and ERT-naïve pediatric…
- Trial name
- NCT03911505
- Testing
- Cipaglucosidase Alfa, Miglustat
- Where
- 17 sites in United States, Australia and 4 more
- Volunteers
- 21 people
- Sponsor
- Amicus Therapeutics
Food Allergy
Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients
It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with low-dose sesame protein compared with standard treatment (elimination diet) in patients with sesame allergy.
- Trial name
- NCT06261554
- Testing
- Dietary Supplement: Low dose OIT
- Where
- Poland
- Volunteers
- 39 people
- Sponsor
- Medical University of Warsaw
Anesthesia, Pediatric Cancer
the Efficacy and Safety of Sugammadex in Children 0-2 Years Old
Sugammadex is a selective antidote to muscle relaxants rocuronium bromide and vecuronium bromide. Sugammadex is a modified gamma-cyclodextrin, a compound that selectively binds rocuronium bromide and vecuronium bromide.
- Conditions
- Anesthesia, Pediatric Cancer, Pediatric Tumor, Pediatric Hepatoblastoma
- Trial name
- NCT03728543
- Testing
- Sugammadex
- Where
- Russia
- Volunteers
- 62 people
- Sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
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