Clinical trials: Pediatric Safety and Effectiveness
Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia, Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
Study Evaluating Brexucabtagene Autoleucel (KTE-X19) in Pediatric and Adolescent Participants With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
The primary objectives of this study are to evaluate the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in pediatric and adolescent participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia…
- Trial name
- ZUMA-4 (NCT02625480)
- Testing
- Brexucabtagene Autoleucel (KTE-X19), Fludarabine, Cyclophosphamide
- Where
- 30 sites in United States, Belgium and 9 more
- Volunteers
- 95 people
- Sponsor
- Kite, A Gilead Company
Ewing Sarcoma
Evaluation of Xaluritamig in Adults, Adolescents and Children With Relapsed or Refractory Ewing Sarcoma (EWS)
The main objectives of this trial are to determine the recommended dose for expansion of xaluritamig (dose confirmation part only) and to determine the safety and tolerability of xaluritamig in adult, adolescent and pediatric…
- Trial name
- NCT07297979
- Testing
- Xaluritamig
- Where
- 13 sites in United States, Australia
- Volunteers
- 50 people
- Sponsor
- Amgen
Hereditary Angioedema
Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With HAE Type I or II
KVD900-303 is an open-label, multicenter clinical trial in patients aged 2 to 11 years old with HAE Type I or II.
- Trial name
- KONFIDENT-KID (NCT06467084)
- Testing
- KVD900 150 mg, KVD900 300 mg, KVD900 600 mg
- Where
- 24 sites in United States, Canada and 5 more
- Volunteers
- 36 people
- Sponsor
- KalVista Pharmaceuticals, Ltd.
Septicemia, Bacterial Infections
Efficacy and Safety of Colistin Based Antibiotic Therapy
To evaluate the efficacy and safety of antibiotic combinations containing Colistin in the treatment of children with multidrug-resistant gram negative infections admitted in the pediatric surgery intensive care unit.
- Trial name
- NCT04764058
- Testing
- Tienam 500, Infusion
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Ain Shams University
Pediatric Malignant Solid Tumor and Epithelioid Sarcoma
A Study of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma.
This is a multicenter, open-label, uncontrolled Phase I/II study to evaluate the efficacy, safety, and pharmacokinetics of ONO-4538HSC in pediatric patients with malignant solid tumors and in patients with epithelioid sarcoma…
- Trial name
- NCT07734116
- Testing
- ONO-4538HSC
- Where
- 15 sites in Japan
- Volunteers
- 50 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Hemophilia A
Study of Pharmacokinetics, Efficacy, and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients With Hemophilia A
The purpose of this study is to evaluate whether rAHF-PFM is effective and safe in the treatment of children with hemophilia A. The study consists of 2 parts.
- Trial name
- NCT00157040
- Testing
- Antihemophilic factor, recombinant, manufactured protein-free
- Where
- 12 sites in United States, Canada and 1 more
- Volunteers
- 50 people
- Sponsor
- Baxalta now part of Shire
Acute Lymphoblastic Leukemia, Pediatric
Safety and Efficacy of Curcumin in Children With Acute Lymphoblastic Leukemia
Assessment of of the biological effects of curcumin on microbiota in children with acute lymphoblastic leukemia
- Trial name
- CurcumPedALL (NCT05045443)
- Testing
- Curcumin, Standard of Care
- Where
- Egypt
- Volunteers
- 30 people
- Sponsor
- Ain Shams University
Healthy
Efficacy of Recruitment Maneuver in Pediatric Patients Under General Anesthesia
During general anesthesia lung collapses and atelectasis occurs. Preservation of atelectasis can cause pulmonary disfunction. The goal of safe anesthesia is to protect the lungs intraoperatively.
- Trial name
- NCT03745443
- Testing
- increase and decrease positive end-expiratory pressure
- Where
- Serbia
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Mother and Child Health Institute of Serbia Dr Vukan Cupic
Kidney Transplantation
Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Cyclosporine Microemulsion and Steroids in Pediatric de Novo Renal Transplant Patients
The aim of this pilot study is to evaluate efficacy and tolerability of EC-MPS b.i.d, with Cyclosporine microemulsion and steroids in pediatric de novo renal transplant patients. Safety and doses variations are also evaluated.
- Trial name
- NCT00154206
- Testing
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Where
- Switzerland
- Volunteers
- 15 people
- Sponsor
- Novartis Pharmaceuticals
Adverse Drug Reactions
Influence of CYP2C19 Genotype on Safety and Efficacy of Voriconazole in Pediatric Patients With Hematologic Malignancy
Voriconazole is a drug used to treat invasive fungal infections. The amount of voriconazole in a person's blood helps to determine how effectively it treats an infection, and how safe it is.
- Trial name
- NCT04743544
- Testing
- Voriconazole
- Where
- Turkey (Türkiye)
- Volunteers
- 62 people
- Sponsor
- Dokuz Eylul University
Irritable Bowel Syndrome With Constipation (IBS-C)
Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years
This is a randomized, double-blind, placebo-controlled study to assess the efficacy, safety and tolerability of tenapanor (25 mg and 50 mg) in pediatric patients (≥12 and <18 years old) with IBS-C when administered twice daily…
- Trial name
- NCT05643534
- Testing
- Tenapanor 50 MG, Tenapanor 25 mg bid
- Where
- 39 sites in United States
- Volunteers
- 180 people
- Sponsor
- Ardelyx
Growth Hormone Deficiency (GHD)
Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
The OraGrowtH Phase 3 Trial is a multi-national trial. The goals of the trial are to study LUM-201 as a treatment for Pediatric Growth Hormone Deficiency (PGHD) in naive to treatment children and validate the LUM-201 predictive…
- Trial name
- NCT06948214
- Testing
- LUM-201
- Where
- 55 sites in United States, Argentina and 6 more
- Volunteers
- 150 people
- Sponsor
- Lumos Pharma
Postoperative Pain
Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity score greater than or equal…
- Trial name
- NCT00801398
- Testing
- Oxymorphone IR
- Where
- 11 sites in United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Pediatric Heart Failure
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week, Double-blind Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure
This study consists of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes, metabolizes and removes the drug LCZ696.
- Trial name
- NCT02678312
- Testing
- LCZ696, Enalapril
- Where
- 98 sites in United States, Argentina and 27 more
- Volunteers
- 393 people
- Sponsor
- Novartis Pharmaceuticals
Primary Immune Deficiency
An Open Label, Multicenter Study to Evaluate the Pharmacokinetics, Efficacy and Safety of ASCENIV™ (IGIV) in Pediatric Subjects With Primary Immunodeficiency Diseases (PIDD)
This is a Phase IV, multicenter, open-label study of Asceniv™ administered as an intravenous infusion of Asceniv™ (IGIV) 300-800 mg/kg every 21 or 28 days in approximately 12 pediatric subjects with Primary Immunodeficiency…
- Trial name
- NCT05070455
- Testing
- Asceniv™
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- ADMA Biologics, Inc.
Sanfilippo Syndrome Type A (MPS IIIA)
A Study to Assess the Safety, Tolerability, and Efficacy of Long-term SOBI003 Treatment in Pediatric MPS IIIA Patients
MPS IIIA, also known as Sanfilippo A, is an inherited lysosomal storage disease (LSD). MPS IIIA is caused by a deficiency in sulfamidase, one of the enzymes involved in the lysosomal degradation of the glycosaminoglycan (GAG)…
- Trial name
- NCT03811028
- Testing
- SOBI003
- Where
- 3 sites in United States, Turkey (Türkiye)
- Volunteers
- 6 people
- Sponsor
- Swedish Orphan Biovitrum
Skin; Deformity
RES Prepared With RECELL® Compared to Conventional Care for Healing of Donor Sites in Ages 1-16 Years
To evaluate whether the time to complete closure is superior for RECELL-treated split-thickness donor sites, compared with Control (standardized dressings only).
- Trial name
- NCT03624192
- Testing
- RECELL® Autologous Cell Harvesting Device, Telfa™ Clear and Xeroform™ dressings
- Where
- 7 sites in United States
- Volunteers
- 3 people
- Sponsor
- Avita Medical
Acute Liver Failure, Fulminant Hepatic Failure
TReatment for ImmUne Mediated PathopHysiology
TReatment for ImmUne Mediated PathopHysiology (TRIUMPH) is a multi-center, three arm, randomized, controlled trial of immunosuppressive therapy for children with acute liver failure.
- Conditions
- Acute Liver Failure, Fulminant Hepatic Failure, Hepatic Encephalopathy, Acute Liver Injury
- Trial name
- TRIUMPH (NCT04862221)
- Testing
- High-dose methylprednisolone, Equine anti-thymocyte globulin, Prednisolone
- Where
- 17 sites in United States
- Volunteers
- 44 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Acute Myeloid Leukemia in Children
CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients
The CHIP-AML22 Master protocol has the overall aim of increasing the cure rate in newly diagnosed pediatric de novo AML patients, while avoiding unnecessary toxicity.
- Trial name
- CHIP-AML22/Q (NCT06262438)
- Testing
- Quizartinib, Etoposide, Dexrazoxane
- Where
- Netherlands
- Volunteers
- 60 people
- Sponsor
- Princess Maxima Center for Pediatric Oncology
Neurogenic Detrusor Overactivity
A Study to Learn How Effective and Safe the Drug 'Mirabegron' is and How Long it Stays in the Body of Children Aged 6 Months to Less Than 3 Years of Age With Neurogenic Detrusor Overactivity
People with neurogenic detrusor overactivity (NDO) have poor bladder control because of how their nerves to the bladder are wired. This can cause high pressure in the bladder, causing it to leak urine by accident (incontinence).
- Trial name
- NCT05621616
- Testing
- mirabegron
- Where
- 3 sites in Philippines, Poland
- Volunteers
- 7 people
- Sponsor
- Astellas Pharma Global Development, Inc.
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