Clinical trials: Pediatric Patient
Primary Immunodeficiencies (PID)
Retrospective, Observational Chart Review Study Conducted in Poland to Document the Management and Clinical Outcome of CUVITRU and HYQVIA in Pediatric Participants (< 18 Years) With Primary Immunodeficiency (PID)
The purpose of this observational, multi-center, retrospective cohort study is to assess treatment patterns of Cuvitru (SCIG) 20 percent (%) and HyQvia (fSCIG) in polish pediatric participants with PID.
- Trial name
- IG-TATRY (NCT04636502)
- Where
- 5 sites in Poland
- Volunteers
- 96 people
- Sponsor
- Shire
Attention-Deficit/Hyperactivity Disorder
Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule)
Open label extension, long-term multicenter study of safety and efficacy of SPN-812 in pediatric ADHD patients
- Trial name
- NCT02736656
- Testing
- SPN-812
- Where
- 16 sites in United States
- Volunteers
- 1,400 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Spinal Muscular Atrophy
A Real-World Medical Chart Review of Spinal Muscular Atrophy Patients Treated With Onasemnogene Abeparvovec in Saudi Arabia
The aim of this retrospective medical chart review is to describe the clinical outcomes, clinical characteristics, and demographics of patients with spinal muscular atrophy (SMA) type 1 treated with onasemnogene abeparvovec (OA)…
- Trial name
- SMA-REAL (NCT07737756)
- Volunteers
- 6 people
- Sponsor
- Novartis Pharmaceuticals
Neuroblastoma, Relapsed Neuroblastoma
67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk, Relapsed, Refractory Neuroblastoma
The aim of this study is to evaluate the safety and efficacy of 67Cu-SARTATE in pediatric patients with high-risk neuroblastoma.
- Conditions
- Neuroblastoma, Relapsed Neuroblastoma, Refractory Neuroblastoma
- Trial name
- NCT04023331
- Testing
- 67Cu-SARTATE, 64Cu-SARTATE
- Where
- 8 sites in United States
- Volunteers
- 21 people
- Sponsor
- Clarity Pharmaceuticals Ltd
Attention Deficit Disorder With Hyperactivity
Classroom Study to Assess Efficacy and Safety of MTS in Pediatric Patients Aged 6-12 With ADHD
Evaluate the behavioral effects of MTS in children aged 6-12 with ADHD
- Trial name
- NCT00466791
- Testing
- Methylphenidate Transdermal System
- Where
- United States
- Volunteers
- 93 people
- Sponsor
- Noven Therapeutics
Cystic Fibrosis
Safety, Tolerability and Pharmacokinetics of BIIL 284 BS in Adult and Pediatric Cystic Fibrosis (CF) Patients
Safety, tolerability and pharmacokinetics following repeated doses (15-day dosing)
- Trial name
- NCT02269189
- Testing
- BIIL 284 BS, high dose, BIIL 284 BS, low dose
- Volunteers
- 36 people
- Sponsor
- Boehringer Ingelheim
Atopic Dermatitis
Open-Label Study of RVT-501 Topical Ointment in Pediatric Patients With Atopic Dermatitis
This is a multicenter, open-label Phase 1b study in pediatric patients age 2-11 years old with extensive atopic dermatitis.
- Trial name
- NCT03415282
- Testing
- RVT-501 0.5% topical ointment
- Where
- 12 sites in United States
- Volunteers
- 24 people
- Sponsor
- Dermavant Sciences GmbH
Constipation
Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation
The primary purpose of this study is to evaluate the safety and efficacy of lubiprostone in a pediatric population with constipation, including the pharmacokinetics of lubiprostone, in a subset of patients.
- Trial name
- NCT00452335
- Testing
- Lubiprostone
- Where
- 19 sites in United States
- Volunteers
- 127 people
- Sponsor
- Sucampo Pharma Americas, LLC
Glioblastoma, Diffuse Intrinsic Pontine Glioma
A Study of DSP-7888 in Pediatric Patients With Relapsed or Refractory High Grade Gliomas
This is a phase 1/2, uncontrolled, open-label, multicenter study in patients with recurrent and relapsed diffuse intrinsic pontine glioma, glioblastoma, or grade III or IV glioma.
- Trial name
- NCT02750891
- Testing
- DSP-7888
- Where
- 6 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Sumitomo Pharma Co., Ltd.
Local Analgesia Via Infiltration
A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients
The study is being conducted to evaluate the safety and efficacy of bupivacaine liposome injection for local infiltration analgesia in pediatric orthopedic surgery in the real world.
- Trial name
- NCT06344091
- Testing
- Bupivacaine Liposome Injection
- Where
- China
- Volunteers
- 232 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Pediculosis
Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice
In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment.
- Trial name
- NCT00963508
- Testing
- Malathion gel 0.5%, Permethrin 1% rinse (Nix Crème)
- Where
- 7 sites in United States
- Volunteers
- 403 people
- Sponsor
- Sun Pharmaceutical Industries, Inc.
Pneumonia, Pneumocystis Carinii, HIV Infections
A Study of Trimetrexate Plus Leucovorin in Children With Pneumocystis Carinii Pneumonia
To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in pediatric patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have demonstrated severe or life-threatening…
- Trial name
- NCT00002317
- Testing
- Trimetrexate glucuronate, Leucovorin calcium
- Where
- United States
- Sponsor
- U.S. Bioscience
Hematological Malignancy
A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
The purpose of the study is to evaluate the pharmacokinetics (PK), safety and tolerability of multiple doses of intravenous (IV) and oral isavuconazonium sulfate administered daily in pediatric patients.
- Trial name
- NCT03241550
- Testing
- isavuconazonium sulfate - intravenous, isavuconazonium sulfate - oral
- Where
- 16 sites in United States
- Volunteers
- 49 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Medulloblastoma
A Phase II Study of Oral LDE225 in Patients With Hedge-Hog (Hh)-Pathway Activated Relapsed Medulloblastoma (MB)
This Phase II study evaluated the safety and efficacy of LDE225 in adult and pediatric patients with Hh-pathway activated, relapsed MB.
- Trial name
- NCT01708174
- Testing
- LDE225, TMZ
- Where
- 41 sites in United States, Australia and 11 more
- Volunteers
- 22 people
- Sponsor
- Novartis Pharmaceuticals
Chemotherapy-Induced Nausea and Vomiting
Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients
The primary objective is to evaluate the efficacy of two different doses of IV palonosetron in the prevention of chemotherapy induced nausea and vomiting in MEC and HEC patients through 120 hours after start of chemotherapy in…
- Trial name
- NCT01442376
- Testing
- Palonosetron, Ondansetron
- Where
- 67 sites in United States, Argentina and 14 more
- Volunteers
- 502 people
- Sponsor
- Helsinn Healthcare SA
Atopic Dermatitis
Phase 2 Study of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis
To evaluate the safety, efficacy (dose response) and pharmacokinetics of 0.3% and 1% OPA-15406 when applied twice daily for 4 weeks in pediatric patients with atopic dermatitis.
- Trial name
- NCT03018691
- Testing
- OPA-15406
- Where
- 4 sites in Japan
- Volunteers
- 73 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Crohn's Disease
High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in Children
The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50…
- Trial name
- NCT00495521
- Testing
- 4-Aminosalicylic acid extended release granules
- Where
- 5 sites in United States
- Volunteers
- 2 people
- Sponsor
- Jacobus Pharmaceutical
Diabetes Mellitus, Type 2
Finding a Safe and Effective Dose of Linagliptin in Pediatric Patients With Type 2 Diabetes
The main objective of this study is to identify the dose of linagliptin in paediatric patients. Other efficacy objectives include the comparison of the lowering effect of linagliptin low dose, high dose and placebo on the fasting…
- Trial name
- NCT01342484
- Testing
- BI1356 low dose, BI1356 high dose
- Where
- 25 sites in United States, Canada and 7 more
- Volunteers
- 40 people
- Sponsor
- Boehringer Ingelheim
Leukemia, Lymphoblastic, Acute, T-cell, Myelogenous Leukemia
A Notch Signalling Pathway Inhibitor for Patients With T-cell Acute Lymphoblastic Leukemia/Lymphoma (ALL)(0752-013)
A Notch signalling pathway inhibitor study in pediatric and adult patients with relapsed (worsening) or refractory (not responding to treatment) T-cell acute lymphoblastic leukemia/lymphoma (T-ALL).
- Conditions
- Leukemia, Lymphoblastic, Acute, T-cell, Myelogenous Leukemia, Chronic Lymphocytic Leukemia, Myelodysplastic Syndromes
- Trial name
- NCT00100152
- Testing
- MK0752, (Notch Inhibitor)
- Volunteers
- 50 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV-1 Infection
Rollover Study Protocol for Pediatric Patients in South Africa for Continued Access to Emtricitabine
The primary objectives of this trial are to provide FTC-203 study participants in South Africa with continued access to the study drug, emtricitabine (FTC), following completion of the FTC-203 study and to collect long-term…
- Trial name
- NCT00743340
- Testing
- Emtricitabine
- Where
- 2 sites in South Africa
- Volunteers
- 50 people
- Sponsor
- Gilead Sciences