Clinical trials: Pediatric Disease
Hematological Malignancies
Safety and Efficacy of SMART101 in Pediatric and Adult Patients With Hematological Malignancies After T Cell Depleted Allo-HSCT
The purpose of this study is to evaluate the safety and the efficacy of SMART101 (Human T Lymphoid Progenitor (HTLP)) injection to accelerate immune reconstitution after T cell depleted allogeneic hematopoietic stem cell…
- Trial name
- NCT04959903
- Testing
- Allogeneic T cell progenitors, cultured ex-vivo
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Smart Immune SAS
Muscular Atrophy, Spinal
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
This is an open-label, single-arm, multicenter clinical study to evaluate the effectiveness and safety of risdiplam administered as an early intervention in pediatric participants with spinal muscular atrophy (SMA) and 2 SMN2…
- Trial name
- HINALEA 1 (NCT05861986)
- Testing
- Risdiplam
- Where
- 16 sites in United States, Germany and 2 more
- Volunteers
- 28 people
- Sponsor
- Hoffmann-La Roche
Influenza
Safety, PK and Effectiveness of IV Peramivir Versus Oseltamivir in Pediatric Subjects With Uncomplicated Influenza
This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of IV peramivir compared to a standard 5 day course of oral oseltamivir in the treatment of pediatric subjects with acute uncomplicated…
- Trial name
- NCT02369159
- Testing
- Peramivir, Oseltamivir
- Where
- 10 sites in United States, South Africa
- Volunteers
- 137 people
- Sponsor
- BioCryst Pharmaceuticals
Acute Kidney Injury, Covid19
Renal Involvement in Hospitalized Children With COVID-19
Covid-19 is an important human and animal pathogen, it mostly causes respiratory and gastrointestinal symptoms. Clinical features range from a common cold to severe diseases such as severe acute respiratory distress syndrome…
- Conditions
- Acute Kidney Injury, Covid19, Renal Dysfunction, Coronavirus Infection
- Trial name
- RIHCC (NCT04788394)
- Testing
- data review, data comparing
- Where
- Qatar
- Volunteers
- 400 people
- Sponsor
- Hamad Medical Corporation
Atopic Dermatitis
A Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Protopic for the Treatment of Atopic Dermatitis
This is an observational study to assess the long-term safety of Protopic® Ointment for the treatment of atopic dermatitis. Patients whose ages are/were < 16 years at the time of first tacrolimus ointment exposure are eligible to…
- Trial name
- APPLES (NCT00475605)
- Where
- 313 sites in United States, Austria and 7 more
- Volunteers
- 8,071 people
- Sponsor
- LEO Pharma
Somatostatin Receptor Positive, NETs
Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors
The purpose of the study is to determine the appropriate pediatric dosage and evaluate the pharmacokinetics (PK) and safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as a monotherapy or following…
- Conditions
- Somatostatin Receptor Positive, NETs, Lymphoma, Solid Tumor
- Trial name
- KinLET (NCT06441331)
- Testing
- Lutetium Lu 177-Edotreotide, Amino Acid Solution
- Where
- 9 sites in United States, France and 1 more
- Volunteers
- 20 people
- Sponsor
- ITM Solucin GmbH
Precursor Cell Lymphoblastic Leukemia-Lymphoma
A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
The purpose of this study is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in pediatric participants with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LL)…
- Trial name
- NCT03384654
- Testing
- Daratumumab, Vincristine, Prednisone
- Where
- 53 sites in United States, Belgium and 8 more
- Volunteers
- 47 people
- Sponsor
- Janssen Research & Development, LLC
Hemophilia B
BAX 326 Pediatric Study
The purpose of this study is to assess BAX 326 pharmacokinetic parameters, to evaluate its hemostatic efficacy, safety, immunogenicity, and changes in health-related quality of life in pediatric patients.
- Trial name
- NCT01488994
- Testing
- BAX326
- Where
- 11 sites in India, Poland and 4 more
- Volunteers
- 23 people
- Sponsor
- Baxalta now part of Shire
Chronic Kidney Disease, Renal Anemia
A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease
Roxadustat is a licensed medicine to treat anemia in adults with chronic kidney disease (CKD). Anemia is a low level of red blood cells.
- Trial name
- NCT05970172
- Testing
- Roxadustat
- Where
- 47 sites in Belgium, Croatia and 17 more
- Volunteers
- 98 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Hereditary Angioedema (HAE)
A Survey of Icatibant in Pediatric Participants With Hereditary Angioedema
This study is a survey in Japan of Icatibant subcutaneous injection 30 mg syringe used to treat children or teenagers with acute attacks of hereditary angioedema (HAE).
- Trial name
- NCT05509569
- Testing
- Icatibant
- Where
- Japan
- Volunteers
- 32 people
- Sponsor
- Takeda
Helminth Infections
A Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections in Pediatric Participants
The purpose of this study is to evaluate the efficacy and safety of mebendazole compared with placebo in pediatric participants with Helminth infections.
- Trial name
- NCT02034162
- Testing
- Mebendazole
- Where
- 3 sites in Ethiopia, Rwanda
- Volunteers
- 295 people
- Sponsor
- Janssen Research & Development, LLC
Hepatitis C Virus (HCV)
A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection
The objectives of this study are to assess the pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir adult formulation in adolescents ages 12 to 17 years and a pediatric formulation of glecaprevir and pibrentasvir in…
- Trial name
- DORA (NCT03067129)
- Testing
- Glecaprevir/Pibrentasvir Adult Formulation, Glecaprevir + Pibrentasvir Pediatric Formulation
- Where
- 38 sites in United States, Belgium and 7 more
- Volunteers
- 129 people
- Sponsor
- AbbVie
Myocardial Ischemia, Heart Defects, Congenital
Spectroscopic Assessment of Myocardial Oxygenation Changes in Pediatric Heart Surgery
The goal of this observational study is to investigate the ability of the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor to observe and monitor changes in cardiac oxygen availability in pediatric…
- Conditions
- Myocardial Ischemia, Heart Defects, Congenital, Reperfusion Injury, Myocardial
- Trial name
- NCT07785141
- Where
- Finland
- Volunteers
- 30 people
- Sponsor
- Spectrocor
Hepatitis C Infection
A Bioequivalence Study of Daclatasvir Tablets and Bioavailability Studies of Daclatasvir and Asunaprevir
Grps 1, 2, 3 "This study will be testing the performance of ASV and DCV pediatric chewable tablets. Grp #4 The purpose of this group is to support the marketing authorization of a DCV 90-mg tablet
- Trial name
- NCT02323594
- Testing
- Daclatasvir, Asunaprevir
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Polyarticular-course Juvenile Idiopathic Arthritis (JIA)
Pediatric Arthritis Study of Certolizumab Pegol
A Multicenter, Open-label Study to Assess the Pharmacokinetics, Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Polyarticular-course Juvenile Idiopathic Arthritis (JIA).
- Trial name
- PASCAL (NCT01550003)
- Testing
- Certolizumab Pegol (CZP)
- Where
- 36 sites in United States, Argentina and 5 more
- Volunteers
- 193 people
- Sponsor
- UCB BIOSCIENCES GmbH
Attention Deficit Disorder With Hyperactivity
Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD
This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.
- Trial name
- NCT00151970
- Testing
- Methylphenidate Transdermal System, Concerta
- Volunteers
- 128 people
- Sponsor
- Noven Therapeutics
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
iotaSOFT Pediatric Study
Prospective, non-randomized, open-label study to evaluate the safety and efficacy of the iotaSOFT Insertion System when used to assist electrode array insertion during cochlear implant surgery in a pediatric population.
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss, Unilateral
- Trial name
- NCT06106373
- Testing
- iotaSOFT Insertion System
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- iotaMotion, Inc.
Myopia
Microdosed Atropine 0.1% and 0.01% Ophthalmic Solutions for Reduction of Pediatric Myopia Progression
This study evaluates the progression of myopia in participants using microdosed atropine 0.01%, atropine 0.1%, or placebo ophthalmic solution. Eligible subjects will administer study medication daily in each eye for 48 months.
- Trial name
- NCT03942419
- Testing
- Atropine 0.1% Ophthalmic Solution, Atropine 0.01% Ophthalmic Solution
- Where
- 18 sites in United States
- Volunteers
- 438 people
- Sponsor
- Eyenovia Inc.
Otitis Media
Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media
Assess tolerability of different dosing formulations (adult versus pediatric).
- Trial name
- NCT00360100
- Testing
- Zmax
- Where
- 10 sites in United States, Argentina and 5 more
- Volunteers
- 120 people
- Sponsor
- Pfizer
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
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