Clinical trials: Pediatric Safety and Effectiveness
HIV Infections
Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children
The purpose of this study is to see if it is safe and effective to give an anti-HIV drug combination of indinavir (IDV) plus stavudine (d4T) plus lamivudine (3TC) to HIV-infected children.
- Trial name
- NCT00000901
- Testing
- Indinavir sulfate, Lamivudine, Stavudine
- Where
- 19 sites in United States, Puerto Rico
- Volunteers
- 24 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Atopic Dermatitis
Open-label Study to Investigate Systemic Exposure in Adult and Pediatric Atopic Dermatitis Patients Treated 8.5 Days With Pimecrolimus Cream 1% Under Occlusion
This study will access the degree to which pimecrolimus is absorbed from pimecrolimus cream 1% into the blood when applied repeatedly under occlusion (i.e.
- Trial name
- NCT00925730
- Testing
- Pimecrolimus
- Where
- 2 sites in Germany
- Volunteers
- 20 people
- Sponsor
- Novartis
Idiopathic Adolescent Scoliosis
Safety Outcomes of Vertebral Body Tethering Technique
The objectives of this study is to assess whether the intervention (Anterior Vertebral Tethering) is a safe and efficacious method of anterior approach surgery for spinal deformity in pediatric scoliosis.
- Trial name
- NCT04119284
- Testing
- Anterior body tether (ABT)
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Nemours Children's Clinic
Bipolar Disorder
Safety and Efficacy Study of Lithium for the Treatment of Pediatric Mania.
Study Design This is the second study of a multiphase, multicenter trial that will comprehensively examine lithium in the treatment of pediatric participants with bipolar I disorder.
- Trial name
- Lithium2 (NCT01166425)
- Testing
- Lithium Carbonate
- Where
- 11 sites in United States
- Volunteers
- 81 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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)
Hypophosphatasia
Relieving Burden of Hypophosphatasia in Adults With Functional Impairment Due to Chronic Disease
The study will evaluate safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 2 different doses (approved dose and lower dose) of asfotase alfa in adult participants with pediatric-onset hypophosphatasia (HPP).
- Trial name
- REBUILD (NCT04189315)
- Testing
- asfotase alfa
- Sponsor
- Alexion Pharmaceuticals, Inc.
Duchenne Muscular Dystrophy
A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) Following Imlifidase Infusion in Participants With Duchenne Muscular Dystrophy (DMD) Determined to Have Pre-existing Antibodies to Recombinant Adeno-Associated Virus Serotype (rAAVrh74)
This is a gene transfer therapy study evaluating the safety of delandistrogene moxeparvovec and delandistrogene moxeparvovec dystrophin expression in association with imlifidase, in participants with DMD with pre-existing…
- Trial name
- NCT06241950
- Testing
- delandistrogene moxeparvovec, imlifidase
- Where
- Spain
- Volunteers
- 5 people
- Sponsor
- Sarepta Therapeutics, Inc.
Atopic Dermatitis
A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis
The purpose of this global Phase 3 clinical study is to investigate the safety and efficacy of tapinarof cream, 1% in participants ages 3 months to 23 months (inclusive) with atopic dermatitis.
- Trial name
- Adoring (NCT07265479)
- Testing
- Tapinarof cream, 1%, Vehicle Cream
- Where
- 46 sites in United States, Canada
- Volunteers
- 187 people
- Sponsor
- Organon and Co
Childhood Astrocytoma, Childhood Diffuse Intrinsic Pontine Glioma
Testing the Addition of an Anti-Cancer Drug, AZD1390, During Radiation Therapy for Newly Diagnosed High Grade Glioma, Diffuse Midline Glioma, or Diffuse Intrinsic Pontine Glioma
This phase I clinical trial studies the side effects and best dose of AZD1390 and to see how well it works when given together with radiation therapy for the treatment of pediatric patients with high grade glioma, diffuse midline…
- Conditions
- Childhood Astrocytoma, Childhood Diffuse Intrinsic Pontine Glioma, Childhood Diffuse Midline Glioma, Childhood Glioblastoma
- Trial name
- NCT06894979
- Testing
- ATM Kinase Inhibitor AZD1390, Biospecimen Collection, Magnetic Resonance Imaging
- Where
- 22 sites in United States
- Volunteers
- 54 people
- Sponsor
- Children's Oncology Group
Cryopyrin-associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome
Efficacy, Safety and Tolerability of ACZ885 in Pediatric Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease
This trial will assess the safety, efficacy and tolerability of ACZ885 in patients aged 4 years and younger with cryopyrin associated periodic syndromes (CAPS)
- Conditions
- Cryopyrin-associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, Neonatal Onset Multisystem Inflammatory Disease
- Trial name
- NCT01302860
- Testing
- ACZ885
- Where
- 12 sites in Belgium, Canada and 5 more
- Volunteers
- 17 people
- Sponsor
- Novartis Pharmaceuticals
Pediatric Cancer
Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Patients
The purpose is to evaluate the effectiveness and safety of fosaprepitant plus ondansetron with dexamethasone or placebo plus ondansetron with dexamethasone in preventing chemotherapy-induced nausea and vomiting (CINV) with MEC/HE…
- Trial name
- NCT04508400
- Testing
- Fosaprepitant,ondansetron, dexamethasone
- Where
- China
- Volunteers
- 108 people
- Sponsor
- Sun Yat-sen University
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Nasopharyngeal Carcinoma
Phase I Study of Becotatug Vedotin for Safety and Efficacy in EGFR-Positive Pediatric Relapsed/Refractory or Metastatic Solid Tumors
There is a significant unmet medical need for effective therapies for pediatric relapsed/refractory solid tumors. EGFR is highly and stably expressed in multiple pediatric solid tumor subtypes, and adult Phase I data of Becotatug…
- Conditions
- Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Nasopharyngeal Carcinoma, Lymphoepithelial Carcinoma, Rhabdomyosarcoma
- Trial name
- MRG003 (NCT07584499)
- Testing
- Becotatug Vedotin
- Where
- China
- Volunteers
- 51 people
- Sponsor
- Sun Yat-sen University
Thymidine Kinase 2 Deficiency
A Study of the Efficacy and Safety of MT1621 in Thymidine Kinase 2 (TK2) Deficiency (Treatment naïve)
This is a Phase 3b, prospective, single-arm, multicenter, open-label treatment study of the efficacy and safety of MT1621 in pediatric and adolescent patients with thymidine kinase 2 deficiency (TK2d).
- Trial name
- NCT04581733
- Testing
- MT1621
- Sponsor
- Zogenix MDS, Inc.
Muscular Atrophy, Spinal
Safety and Efficacy of Intravenous OAV101 (AVXS-101) in Pediatric Patients With Spinal Muscular Atrophy (SMA) (OFELIA)
This was a phase IV Open-label, single-arm, single-dose, multicenter study, to evaluate the safety, tolerability and efficacy of intravenous administration of OAV101 (AVXS-101) in patients with SMA with bi-allelic mutations in…
- Trial name
- OFELIA (NCT05073133)
- Testing
- OAV101
- Where
- 5 sites in Argentina, Brazil
- Volunteers
- 16 people
- Sponsor
- Novartis Pharmaceuticals
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
Primary Sclerosing Cholangitis
Safety and Efficacy Study of Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis
Primary sclerosing cholangitis (PSC), although uncommon, is a devastating and insidiously progressive liver disease, resulting from advancing inflammation, fibrosis and obliteration of the bile ducts in the liver, leading to…
- Trial name
- NCT01088607
- Testing
- ursodeoxycholic acid (UDCA)
- Where
- 12 sites in United States
- Volunteers
- 27 people
- Sponsor
- University of Tennessee
Seasonal Allergic Rhinitis
Study of the Efficacy and Safety of MK-0476 in Japanese Pediatric Participants With Seasonal Allergic Rhinitis (MK-0476-519)
This study will evaluate the efficacy and safety of montelukast (MK-0476) in the treatment of Japanese pediatric participants with seasonal allergic rhinitis (SAR).
- Trial name
- NCT01857063
- Testing
- Montelukast
- Volunteers
- 220 people
- Sponsor
- Organon and Co
Autism
Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism
The purpose of this study is to investigate the safety and efficacy of memantine extended release, as well as its extent of absorption in pediatric patients with autism.
- Trial name
- NCT00872898
- Testing
- Memantine - Extended Release (ER)
- Where
- 17 sites in United States
- Volunteers
- 124 people
- Sponsor
- Forest Laboratories
Anxiety Neuroses, Anxiety States, Neurotic
A Study in Pediatric Participants With Generalized Anxiety Disorder
The purpose of this study is to find out if duloxetine [30-120 milligrams (mg)] given once a day by mouth for 10 weeks to children and adolescents, is better than placebo when treating Generalized Anxiety Disorder (GAD).
- Conditions
- Anxiety Neuroses, Anxiety States, Neurotic, Neuroses, Anxiety
- Trial name
- NCT01226511
- Testing
- Duloxetine
- Where
- 24 sites in United States, Mexico and 1 more
- Volunteers
- 281 people
- Sponsor
- Eli Lilly and Company
Malaria, Vivax
A Pharmacokinetics, Safety and Efficacy Study of Tafenoquine (TQ) in Pediatric Subjects With Plasmodium Vivax (P. Vivax) Malaria
This is a prospective, open-label, multicenter, non-comparative, single arm study of pediatric subjects with Plasmodium vivax (P. vivax) malaria, aged 6 months to <16 years of age. A total of 60 subjects will be enrolled.
- Trial name
- NCT02563496
- Testing
- Tafenoquine, Chloroquine
- Where
- 4 sites in Colombia, Vietnam
- Volunteers
- 60 people
- Sponsor
- GlaxoSmithKline
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