Clinical trials: Pediatric Safety and Effectiveness
Warts
An up to Twelve Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric Subjects
The primary purpose of this study is to evaluate the effectiveness in pediatric subjects of three different strengths of resiquimod gel applied to common wart(s) three times a week for up to twelve weeks.
- Trial name
- NCT00116662
- Testing
- Resiquimod
- Where
- 10 sites in United States
- Volunteers
- 84 people
- Sponsor
- Graceway Pharmaceuticals, LLC
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
HIV Infections
Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs
Treatment of HIV-infected patients involves combining drugs from different classes of anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI).
- Trial name
- NCT00016718
- Testing
- Didanosine (ddI), Efavirenz (EFV), Emtricitabine (FTC)
- Where
- 18 sites in United States, Puerto Rico
- Volunteers
- 43 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Advanced Solid Tumors, Metastatic Pancreatic Cancer
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Background: Metastasis is the spread of cancer from one organ to a nonadjacent organ. It causes 90% of cancer deaths. No treatment specifically prevents or reduces metastasis. Researchers hope a new drug can help.
- Conditions
- Advanced Solid Tumors, Metastatic Pancreatic Cancer, Pediatric Solid Tumor, Advanced Breast Cancer
- Trial name
- NCT04222413
- Testing
- Metarrestin
- Where
- 2 sites in United States
- Volunteers
- 116 people
- Sponsor
- National Cancer Institute (NCI)
Niemann-Pick Disease, Type C1
Phase 3 Study to Evaluate Intravenous Trappsol(R) Cyclo(TM) in Pediatric and Adult Patients With Niemann-Pick Disease Type C1
A prospective, randomized, double-blind, placebo controlled, multi-center therapeutic study for patients age 3 and older with confirmed diagnosis of Niemann Pick disease type C1 (NPC1).
- Trial name
- TransportNPC (NCT04860960)
- Testing
- Hydroxypropyl-beta-cyclodextrin
- Where
- 35 sites in United States, Argentina and 11 more
- Volunteers
- 94 people
- Sponsor
- Cyclo Therapeutics, Inc.
Proteinuric Kidney Disease
Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1-Mediated Proteinuric Kidney Disease
The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease.
- Trial name
- AMPLITUDE (NCT05312879)
- Testing
- VX-147
- Where
- 314 sites in United States, Belgium and 11 more
- Volunteers
- 522 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Ulcerative Colitis
Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) Study in Ulcerative Colitis
Prospective, single-center, sham-controlled, double-blinded 12-week study designed to evaluate the safety and efficacy of the RAVANS device in subjects with Ulcerative Colitis.
- Trial name
- NCT05662059
- Testing
- RAVANS
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Cala Health, Inc.
B-Cell Acute Lymphoblastic Leukemia
Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients
This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in de novo HR pediatric and young adult B-ALL patients who received first-line treatment and are EOC MRD…
- Trial name
- CASSIOPEIA (NCT03876769)
- Testing
- CTL019
- Where
- 43 sites in United States, Belgium and 9 more
- Volunteers
- 121 people
- Sponsor
- Novartis Pharmaceuticals
Ulcerative Colitis
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- SHINE-2 (NCT05784246)
- Testing
- Mirikizumab IV, Mirikizumab SC
- Where
- 34 sites in United States, Belgium and 9 more
- Volunteers
- 63 people
- Sponsor
- Eli Lilly and Company
Myopia
Evaluate the Efficacy and Safety of CTO0308 in Pediatric Patients With Myopia
This study was to evaluate the superiority of the myopia progression control effect in the treatment group compared with the control group, evaluated by the change in spherical equivalent (SE) after 12 months of administration of…
- Trial name
- NCT07790640
- Testing
- CTO0308
- Where
- South Korea
- Volunteers
- 351 people
- Sponsor
- Taejoon Pharmaceutical Co., Ltd.
Asthma
A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma
The purpose of this study is to evaluate the superiority in terms of efficacy and evaluate the safety of QMF149 (indacaterol (acetate) / mometasone (furoate)) compared to budesonide in children from 6 to less than 12 years of age…
- Trial name
- NCT05562466
- Testing
- QMF149, Budesonide
- Where
- 65 sites in Argentina, Austria and 15 more
- Volunteers
- 200 people
- Sponsor
- Novartis Pharmaceuticals
Pediatric Hydrocephalus
The Ventricular Catheter Placement Study: Assessment of Efficacy and Safety of an Ultrasound Guided Shunt Insertion Technique
Shunt failure remains a significant problem in pediatric patients with hydrocephalus. If reliable techniques for the accurate placement of ventricular catheters can be developed, shunt survival may improve.
- Trial name
- NCT01007786
- Where
- 4 sites in United States, Canada
- Volunteers
- 67 people
- Sponsor
- University of Utah
Immune Thrombocytopenia (ITP)
V-IMMUNE® for Immune Thrombocytopenia
This is a multicenter, prospective clinical trial evaluating the efficacy and safety of V-IMMUNE®, a 5% human normal immunoglobulin formulation administered intravenously, for the treatment of immune thrombocytopenia (ITP) in…
- Trial name
- TIP (NCT06962631)
- Testing
- 5% (5g/100 ml) intravenous immunoglobin
- Where
- 2 sites in Brazil
- Volunteers
- 31 people
- Sponsor
- On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA.
Alpha-Mannosidosis
Trial on Safety and Efficacy of Velmanase Alfa Treatment in Pediatric Patients With Alpha-Mannosidosis
The main objectives of the study are to evaluate safety and efficacy of repeated treatment with recombinant human alfa-mannosidase of patients with alfa-mannosidosis aged less than 6 years
- Trial name
- rhLaman-08 (NCT02998879)
- Testing
- Velmanase Alfa (e.g. Lamazym)
- Where
- 6 sites in Austria, Denmark and 3 more
- Volunteers
- 5 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Thrombotic Microangiopathies, Hematopoietic Stem Cell Transplantation
Efficacy and Safety Study of Narsoplimab in Pediatric Patients With High-Risk Hematopoietic Stem Cell Transplant TMA
The purpose of this study is to evaluate the safety and efficacy of narsoplimab in pediatric patients with thrombotic microangiopathies (TMA) following hematopoietic stem cell transplant (HSCT).
- Trial name
- NCT05855083
- Testing
- Biological: narsoplimab
- Where
- 16 sites in United States, Germany and 3 more
- Volunteers
- 18 people
- Sponsor
- Omeros Corporation
Pituitary Disease
Safety and Efficacy of Pegvisomant in Children With Growth Hormone Excess
Background: For children with gigantism, too much growth hormone (GH) in the body causes abnormal growth and many other problems. Current treatments often don t work; no medical treatment is approved by FDA.
- Trial name
- NCT03882034
- Testing
- Pegvisomant
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Cerebral Palsy, Spastic Paraplegia and Hemiparesis
Treatment With Xeomin Versus Botox in Children With Spastic Equine and Equinovarus Foot Deformation in Pediatric Cerebral Palsy
1. To assess the clinical and neurophysiological efficacy of Xeomin® vs. Botox® in children with spastic equine and equinovarus foot deformation in pediatric cerebral palsy 2.
- Conditions
- Cerebral Palsy, Spastic Paraplegia and Hemiparesis, Equine and Equinovarus Foot Deformation
- Trial name
- XEBEC (NCT02188277)
- Testing
- Xeomin, Botox®
- Where
- 3 sites in Russia
- Volunteers
- 64 people
- Sponsor
- Merz Pharmaceuticals GmbH
Chemotherapy Induced Nausea and Vomiting
A Study of the Safety and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Pediatric Participants (MK-0869-208)
This study will compare the safety and efficacy of a three-day oral aprepitant regimen (aprepitant plus ondansetron) to ondansetron alone in the prevention of chemotherapy-induced nausea and vomiting (CINV) in the 120 hours…
- Trial name
- NCT01362530
- Testing
- Aprepitant 125 mg, Aprepitant 80 mg, Aprepitant powder for suspension (PFS)
- Volunteers
- 307 people
- Sponsor
- Merck Sharp & Dohme LLC
Still´s Disease
A Phase II Trial to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Pediatric and Adult Participants With Still's Disease
The study is a phase II trial designed to evaluate the clinical efficacy, safety, and tolerability of MAS825 (arumakimig) in pediatric and adult participants with Still's disease
- Trial name
- NCT07203001
- Testing
- MAS825
- Where
- 23 sites in United States, Canada and 6 more
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Active Juvenile Psoriatic Arthritis
Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis
The study will aim to estimate the efficacy of apremilast compared with placebo in the treatment of juvenile psoriatic arthritis (JPsA) in pediatric participants 5 to less than 18 years of age.
- Trial name
- PEAPOD (NCT04804553)
- Testing
- Apremilast
- Where
- 44 sites in Belgium, France and 12 more
- Volunteers
- 60 people
- Sponsor
- Amgen
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