Clinical trials: Pediatric Safety and Effectiveness
Procedural Pain
Efficacy and Safety of ALGRX 3268 in Management of Needlestick Pain in Children.
Minor needlestick procedures often cause significant pain and distress in pediatric patients yet interventions to reduce pain are used infrequently.
- Trial name
- NCT00140088
- Testing
- ALGRX 3268
- Where
- United States
- Volunteers
- 504 people
- Sponsor
- AlgoRx Pharmaceuticals
Crohn's Disease
A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease
Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever.
- Trial name
- RISE (NCT05995353)
- Testing
- Risankizumab
- Where
- 85 sites in United States, Belgium and 19 more
- Volunteers
- 110 people
- Sponsor
- AbbVie
RSV Infection, RSV
A Phase 2 Study to Investigate the Efficacy and Safety of Zelicapavir in Participants Aged ≥28 Days to ≤36 Months of Age Infected With Respiratory Syncytial Virus
Zelicapavir is a novel, orally administered, nonfusion replication inhibitor of RSV. It is being investigated in this Phase 2 study (EDP 938-203) as a potential treatment for RSV infection in both hospitalized and…
- Conditions
- RSV Infection, RSV, Respiratory Syncytial Virus (RSV)
- Trial name
- NCT07482657
- Testing
- zelicapavir
- Where
- 8 sites in Thailand
- Volunteers
- 150 people
- Sponsor
- Enanta Pharmaceuticals, Inc
Diabetes Mellitus, Type 2 Diabetes
Study to Assess Safety & Efficacy of Sitagliptin as Initial Oral Therapy for Treatment of Type 2 Diabetes Mellitus in Pediatric Participants. (MK-0431-083)
The purpose of the study is to assess the safety of the addition of sitagliptin, and its effect on hemoglobin A1c (A1C) in pediatric participants 10-17 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic…
- Trial name
- NCT01485614
- Testing
- Sitagliptin, Metformin, Glycemic Rescue 1
- Volunteers
- 200 people
- Sponsor
- Merck Sharp & Dohme LLC
Non-Segmental Vitiligo
A Study to Learn How Effective, Safe, and Tolerable Upadacitinib is for Young Participants With Non-segmental Vitiligo
Vitiligo is a common, long-lasting disease that happens when the immune system attacks melanocytes (skin cells that produce the skin-coloring pigment melanin) in the skin leading to loss of color.
- Trial name
- Ph3 Peds Viti (NCT07896434)
- Testing
- Upadacitinib
- Volunteers
- 154 people
- Sponsor
- AbbVie
Familial Hypercholesterolemia
Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia)
The main purpose of this study is to describe the safety and tolerability of 80 weeks of subcutaneous (SC) evolocumab when added to standard of care in children 10 to 17 years of age with familial hypercholesterolemia.
- Trial name
- HAUSER-OLE (NCT02624869)
- Testing
- Evolocumab
- Where
- 46 sites in United States, Australia and 21 more
- Volunteers
- 163 people
- Sponsor
- Amgen
Chemotherapy-Induced Neutropenia
Clinical Study on the Safety, Efficacy and Pharmacokinetics of Telpegfilgrastim in Pediatric Cancer Patients with Chemotherapy
This study is a multicenter, single-arm, prospective study. The study population includes children with cancer who require high-intensity chemotherapy.
- Trial name
- Telpegfilgrast (NCT06857292)
- Testing
- Telpegfilgrastim
- Where
- China
- Volunteers
- 97 people
- Sponsor
- Sun Yat-sen University
Growth Hormone Deficiency (GHD), Growth Hormone Deficiency in Children
GB06 Phase III Trial for Pediatric Growth Hormone Deficiency
This study aims to evaluate the efficacy and safety of GB06 (a biosimilar of Norditropin®FlexProTM from Novo Nordisk) for the treatment of growth disorders caused by growth hormone deficiency (GHD) in children.
- Conditions
- Growth Hormone Deficiency (GHD), Growth Hormone Deficiency in Children, Growth Hormone Deficiency, Pediatric
- Trial name
- NCT07553351
- Testing
- GB06, Norditropin®FlexProTM
- Where
- China
- Volunteers
- 192 people
- Sponsor
- Kexing Biopharm Co., Ltd.
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
Tympanic Membrane Perforation
Perf-Fix Study for Chronic Tympanic Membrane Repair
The purpose of the study is to assess the effectiveness of Perf-Fix as a gel patch to aid in the natural healing process to close chronic, >25% tympanic membrane perforation.
- Trial name
- NCT06083181
- Testing
- Perf-Fix Otologic Gel Patch
- Where
- 7 sites in United States
- Volunteers
- 71 people
- Sponsor
- Tympanogen
Spinal Muscular Atrophy
Safety and Efficacy of Intravenous OAV101 (AVXS-101) in Pediatric Patients With Spinal Muscular Atrophy (SMA)
To evaluate the safety, tolerability and efficacy of intravenous administration of OAV101 (AVXS-101) in patients with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene weighing ≥…
- Trial name
- SMART (NCT04851873)
- Testing
- OAV101
- Where
- 13 sites in United States, Australia and 7 more
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
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
Migraine
A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age
The primary objective of the study is to evaluate the efficacy of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM).
- Trial name
- NCT04458857
- Testing
- Fremanezumab
- Where
- 89 sites in United States, Canada and 7 more
- Volunteers
- 235 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Cerebral Palsy Hypoxic-Ischemic Encephalopathy Intracranial Hemorrhage
Autologous Bone Marrow Mononuclear Cell Transplantation Combined With Rehabilitation in Children With Sequelae of Hypoxic-Ischemic Encephalopathy or Intracranial Hemorrhage
This study evaluates the safety and preliminary efficacy of autologous bone marrow mononuclear cell transplantation combined with rehabilitation in children with neurological sequelae caused by hypoxic-ischemic brain injury or…
- Trial name
- BMMCT-CP (NCT07527104)
- Testing
- Autologous Bone Marrow Mononuclear Cell Transplantation
- Where
- Vietnam
- Volunteers
- 60 people
- Sponsor
- National Children's Hospital, Vietnam
Hepatitis C, Chronic
Study of PEG-Intron Plus REBETOL in Pediatric Subjects With Chronic Hepatitis C (Study P02538 Part 1)
The primary objective is to assess the safety, efficacy and tolerability of the combination of PEG-Intron plus REBETOL in pediatric subjects with chronic hepatitis C.
- Trial name
- NCT00104052
- Testing
- peginterferon alfa-2b (PEG2b) (SCH 54031), ribavirin (SCH 18908)
- Volunteers
- 107 people
- Sponsor
- Merck Sharp & Dohme LLC
Central Nervous System Indication, Pediatric Patients
Pharmacokinetics, Safety and Efficacy of P03277 in Pediatric Patients Undergoing Central Nervous System Contrast-enhanced MRI
This is a pharmacokinetics (PK), open-label, uncontrolled, multicenter phase II trial with age-staggered approach. The primary objective is to evaluate the PK profile of gadopiclenol in plasma following single IV injection of…
- Conditions
- Central Nervous System Indication, Pediatric Patients, Body Indication
- Trial name
- NCT03749252
- Testing
- P03277
- Where
- 16 sites in Bulgaria, Hungary and 3 more
- Volunteers
- 80 people
- Sponsor
- Guerbet
Migraine
Efficacy & Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE
To evaluate the efficacy and safety of zolmitriptan nasal spray (ZNS) in the acute treatment of migraine headache in subjects ages 6 to 11 years. Part 1: Approximately 20 weeks (includes screening and double-blind treatment).
- Trial name
- NCT03275922
- Testing
- ZNS
- Where
- 47 sites in United States
- Volunteers
- 374 people
- Sponsor
- Impax Laboratories, LLC
Major Depressive Disorder
TDCS in Pediatric and Teenage Patients With Major Depressive Disorder During COVID-19 Pandemic
The purpose of this study is to assess safety and efficacy of nodal transcranial direct current stimulation in pediatric and teenager population with major depressive disorder in the COVID-19 pandemic.
- Trial name
- NCT04780152
- Testing
- Transcranial Direct Current Stimulation, Fluoxetine Tablets
- Where
- Mexico
- Volunteers
- 172 people
- Sponsor
- El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Lymphoma
Evaluate the Efficacy and Safety of Rasburicase (Fasturtec®) in the Prevention and Treatment of Hyperuricemia in Pediatric Patients With Non-Hodgkin's Lymphoma and Acute Leukemia
Primary Objective: To evaluate safety of rasburicase in pediatric patients with NHL and AL Secondary Objective: To assess efficacy of rasburicase for prevention and treatment of hyperuricemia
- Trial name
- RAISE (NCT04349306)
- Testing
- RASBURICASE SR29142
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Sanofi
Chemotherapy Induced Nausea and Vomiting, Pediatric Cancer Patients
Comparative Study of Fosaprepitant and Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Caner Patients
Children aged 2-12 years scheduled to receive moderately or highly emetogenic chemotherapy were randomly assigned to arm-A (fosaprepitant) or arm-B (aprepitant).
- Trial name
- NCT04873284
- Testing
- fosaprepitant, aprepitant, Granisetron plus dexamethasone
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Shanghai Children's Medical Center
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