Clinical trials: Pediatric Safety and Effectiveness
IgAN, IgAVN
Study of Ravulizumab in Pediatric Participants With Primary IgAN
The primary objectives of this study are to characterize ravulizumab pharmacokinetics (PK) and pharmacodynamics (PD), and to evaluate safety and efficacy following ravulizumab IV dosing in pediatric participants with IgAN or…
- Conditions
- IgAN, IgAVN, Immunoglobulin A Nephropathy, Immunoglobulin A Vasculitis Associated Nephritis
- Trial name
- NCT07024563
- Testing
- Ravulizumab
- Where
- 15 sites in United States, China and 5 more
- Volunteers
- 36 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
H Pylori Gastritis
Comparison of Efficacy of Triple Regimen Based on Clarithromycin VS Metronidazole in Children
All children from 1day to 18years of age, diagnosed with peptic ulcer disease due to H pylori at Pakistan Institute of Medical Sciences, Islamabad, from July 2020 to December 2021 will be included in the study.
- Trial name
- CETR (NCT04721704)
- Testing
- Clarithromycin+ Amoxicillin + Omeprazole, Metronidazole +Amoxicillin + Omeprazole
- Where
- 2 sites in Pakistan
- Volunteers
- 36 people
- Sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
Brain Tumor
Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures
The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
- Trial name
- NCT04085887
- Testing
- Panitumumab-IRDye800, Pinpoint-IR9000 endoscopic/handheld device, Explorer Air camera
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Stanford University
Hodgkin Lymphoma, Lymphocytic Leukemia
Pilot Study of Non-Myeloablative, HLA-Matched Allogeneic Stem Cell Transplantation for Pediatric Hematopoietic Malignancies
Background: Allogeneic blood and marrow stem cell transplantation (BMT) plays an important role in the curative treatment of a number of pediatric malignancies.
- Conditions
- Hodgkin Lymphoma, Lymphocytic Leukemia, Mixed Cell Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT00013533
- Testing
- Stem cell transplantation
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- National Cancer Institute (NCI)
Atopic Dermatitis
Extension Study of Pimecrolimus Cream in Pediatric Patients With Atopic Dermatitis
Pimecrolimus, which is an ascomycin derivative, is an anti-inflammatory non-steroidal agent. In this study, the long-term safety and efficacy of Pimecrolimus cream will be evaluated in Japanese pediatric patients with atopic…
- Trial name
- NCT00231998
- Testing
- Pimecrolimus
- Where
- Japan
- Volunteers
- 240 people
- Sponsor
- Novartis
Influenza
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Participants 1 to <12 Years of Age With Influenza Symptoms
The purpose of this study is to evaluate the safety of a single dose baloxavir marboxil compared with 5 days of oseltamivir administered twice a day (BID) in Chinese pediatric participants aged 1 to < 12 years with influenza…
- Trial name
- NCT06774859
- Testing
- Baloxavir Marboxil, Oseltamivir
- Where
- 16 sites in China
- Volunteers
- 100 people
- Sponsor
- Hoffmann-La Roche
Anal Fissure
Pharmacokinetic,Safety and Exploratory Efficacy of RECTIV® in Adolescents With Chronic Anal Fissure
RECTIV® is an ointment containing 0.4% nitroglycerin (NTG) for the treatment of moderate to severe pain associated with chronic anal fissure approved in June 2011 by the US Food and Drug Administration (FDA) for adults.
- Trial name
- NCT01920074
- Testing
- Nitroglycerin Ointment 0.4%
- Where
- 6 sites in United States
- Sponsor
- Forest Laboratories
Hepatitis C, Chronic
5 Year Long-term Follow up in Pediatric Participants Who Received PegIntron Plus Rebetol in P02538 Part I (P02538 Pt 2)
Study P02538 Part 2 is a 5-year long term follow-up (LTFU) study in pediatric participants who were treated with at least one dose of peginterferon alfa-2b (PEG-IFN) and ribavirin (RBV) and who completed the follow-up in the…
- Trial name
- NCT00761735
- Testing
- Peginterferon alfa-2b, Ribavirin
- Volunteers
- 94 people
- Sponsor
- Merck Sharp & Dohme LLC
Invasive Mucormycosis, Invasive Aspergillosis
A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants
The purpose of this study was to evaluate the safety, tolerability, and efficacy of isavuconazonium sulfate in pediatric participants.
- Trial name
- NCT03816176
- Testing
- Isavuconazonium sulfate
- Where
- 10 sites in United States, Belgium and 1 more
- Volunteers
- 31 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Hunter Syndrome
A Study of Elaprase in Children and Adults With Hunter Syndrome (Mucopolysaccharidosis II) in India
The main aim of this study is to learn more about the safety profile of Elaprase in Indian children and adults with hunter syndrome.
- Trial name
- NCT05058391
- Testing
- Elaprase
- Where
- 5 sites in India
- Volunteers
- 5 people
- Sponsor
- Takeda
Idiopathic Thrombocytopenic Purpura, Thrombocytopenia
Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients
The purpose of this study is to evaluate the efficacy of romiplostim in the treatment of thrombocytopenia in pediatric patients with Immune thrombocytopenia purpura (ITP) as measured by durable platelet response.
- Conditions
- Idiopathic Thrombocytopenic Purpura, Thrombocytopenia, Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP), Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
- Trial name
- NCT01444417
- Testing
- Romiplostim
- Where
- 33 sites in United States, Australia and 1 more
- Volunteers
- 62 people
- Sponsor
- Amgen
Urinary Bladder, Overactive
A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076
This was a 40-week study to investigate how safe and effective solifenacin solution was in treating children or adolescents with symptoms of overactive bladder (OAB), who completed study 905-CL-076 (NCT01565707).
- Trial name
- LEOPARD (NCT01655069)
- Testing
- Solifenacin succinate suspension
- Where
- 39 sites in United States, Belgium and 14 more
- Volunteers
- 148 people
- Sponsor
- Astellas Pharma Europe B.V.
Helicobacter Pylori Infection
Vonoprazan-Amoxicillin Dual Therapy for Helicobacter Pylori Infection in United States Adolescents
Helicobacter pylori (H. pylori) is a common bacterial infection of the stomach that can cause chronic stomach inflammation, ulcers, and other digestive problems.
- Trial name
- NCT07860112
- Testing
- Vonoprazan, Amoxicillin
- Volunteers
- 55 people
- Sponsor
- Boston Children's Hospital
Asthma
Safety and Efficacy of Berodual® Inhaled Via Respimat® Compared to MDI (Metered Dose Inhaler) in Pediatric Patients With Asthma
Study to demonstrate that at least one of the two doses of Berodual® (50 µg fenoterol hydrobromide + 20 µg ipratropium bromide and 25 µg fenoterol hydrobromide + 10 µg ipratropium bromide, 1 puff t.i.d.) administered via…
- Trial name
- NCT02182505
- Testing
- Berodual® Respimat®, low dose, Berodual® Respimat®, high dose, Berodual® MDI
- Volunteers
- 535 people
- Sponsor
- Boehringer Ingelheim
Hepatitis C Virus Infection
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) in treating hepatitis C virus (HCV) infection in pediatric participants who are undergoing cancer…
- Trial name
- NCT02868242
- Testing
- LDV/SOF
- Where
- Egypt
- Volunteers
- 19 people
- Sponsor
- Gilead Sciences
Acute Myeloid Leukemia
Study of Talazoparib in Combination With Chemotherapy in Relapsed Pediatric AML to Determine Safety and Efficacy
This is a Phase 1, open label, multicenter, dose finding study with dose expansion intended to evaluate the safety and tolerability of talazoparib in combination with conventional chemotherapy.
- Trial name
- PARPAML (NCT05101551)
- Testing
- Talazoparib, Topotecan, Gemcitabine
- Where
- 9 sites in United States
- Volunteers
- 34 people
- Sponsor
- Norman J. Lacayo
Adolescent Lupus Nephritis, Pediatric Lupus Nephritis
Long-Term Voclosporin Treatment in Adolescent and Pediatric Subjects With Lupus Nephritis
The purpose of this study is to assess the long-term safety and tolerability of voclosporin for up to an additional 12 months following completion of treatment in the AUR-VCS-2020-03 study (VOCAL) in adolescent and pediatric…
- Trial name
- VOCAL-EXT (NCT05962788)
- Testing
- voclosporin
- Where
- 6 sites in United States, Colombia and 3 more
- Volunteers
- 4 people
- Sponsor
- Aurinia Pharmaceuticals Inc.
Childhood Absence Epilepsy
Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures
The primary purpose of this study is to assess the efficacy of Cannabidiol Oral Solution in the treatment of pediatric participants with treatment-resistant childhood absence seizures.
- Trial name
- NCT03336242
- Testing
- Cannabidiol Oral Solution
- Where
- 11 sites in United States
- Volunteers
- 20 people
- Sponsor
- Radius Pharmaceuticals, Inc.
Peanut Allergy
Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
Primary objective is to assess whether dupilumab as adjunct to AR101 compared to placebo improves desensitization at the completion of up-dosing, defined as an increase in the proportion of participants who pass a post up-dosing…
- Trial name
- NCT03682770
- Testing
- Dupilumab, AR101
- Where
- 25 sites in United States
- Volunteers
- 148 people
- Sponsor
- Regeneron Pharmaceuticals
Euthyroid Sick Syndrome
Levothyroxine for Children With Euthyroid Sick Syndrome
The purpose of this study is to determine whether levothyroxine is effective and safe in the treatment of children with euthyroid sick syndrome, hospitalized in a pediatric intensive care unit.
- Trial name
- NCT01631305
- Testing
- Levothyroxine, Calcium magnesia
- Where
- Mexico
- Volunteers
- 80 people
- Sponsor
- Sinaloa Pediatric Hospital
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