Clinical trials: Phase 1
Burns
SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma
This clinical trial is designed to assess the safety, effectiveness and benefits of Self Assembled Skin Substitute SASS grafts as a permanent skin replacement for the treatment of full-thickness burn wounds that require permanent…
- Trial name
- NCT02350205
- Testing
- Self assembled skin substitute (SASS)
- Where
- 8 sites in Canada
- Volunteers
- 52 people
- Sponsor
- CHU de Quebec-Universite Laval
Neuroblastoma
Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral β-glucan for High-Risk Neuroblastoma
In the first part of this study we found the highest dose of the vaccine that did not have too many side effects. We are now trying to find out what effects the vaccine has when given at the same dose to all patients.
- Trial name
- NCT00911560
- Testing
- adjuvant OPT-821 in a vaccine containing two antigens (GD2L and GD3L) covalently linked to KLH, oral β-glucan
- Where
- United States
- Volunteers
- 374 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Streptococcus Pneumoniae Infection
Clinical Trial of the 24-valent Pneumococcal Polysaccharide Conjugate Vaccine (CRM197/Tetanus Toxoid)
This clinical trial consists of Phase I and Phase II. The objective is to evaluate the safety and immunogenicity of the 24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) in individuals aged 2 months…
- Trial name
- NCT07600983
- Testing
- 24-valent pneumococcal polysaccharide conjugate vaccine (CRM197/tetanus toxoid) (referred to as PCV24) (dose M), PCV24 vaccine (dose H), PCV24 vaccine (dose M)
- Where
- 2 sites in China
- Volunteers
- 854 people, healthy volunteers welcome
- Sponsor
- CanSino Biologics Inc.
Recurrent Childhood Neuroblastoma, Recurrent Childhood Osteosarcoma
Testing a New Immune Cell Therapy, GD2-Targeted Modified T-cells (GD2CART), in Children, Adolescents, and Young Adults With Relapsed/Refractory Osteosarcoma and Neuroblastoma, GD2-CAR PERSIST Trial
This phase I trial investigates the side effects and determines the best dose of an immune cell therapy called GD2CART, as well as how well it works in treating patients with osteosarcoma or neuroblastoma that has come back…
- Conditions
- Recurrent Childhood Neuroblastoma, Recurrent Childhood Osteosarcoma, Recurrent Neuroblastoma, Recurrent Osteosarcoma
- Trial name
- NCT04539366
- Testing
- Biopsy Procedure, Biospecimen Collection, Bone Marrow Aspiration
- Where
- 6 sites in United States
- Volunteers
- 73 people
- Sponsor
- National Cancer Institute (NCI)
Pulmonary Vein Stenosis
Calculating Wall Shear Stress in Infant Pulmonary Veins
The purpose of this study is to better understand pediatric pulmonary vein stenosis (PVS), which is the narrowing of blood vessels that connect the lungs to the heart. PVS is a life-threatening disease without a clear cause.
- Trial name
- PVS-WSS (NCT06440408)
- Testing
- Ferumoxytol
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Children's Hospital of Philadelphia
Congenital Hearing Loss Secondary to Biallelic Mutations of the Otoferlin Gene (OTOF)
A Study of DB-OTO, an Adeno-Associated Virus (AAV) Based Gene Therapy, in Children/Infants, Adolescents and Adults With Hearing Loss Due to Otoferlin Mutations
Regeneron is conducting a study of an investigational new drug called DB-OTO. DB-OTO is a gene therapy that is being developed to treat pediatric and adult participants who have severe-to profound and profound hearing loss due to…
- Trial name
- CHORD (NCT05788536)
- Testing
- DB-OTO
- Where
- 17 sites in United States, Germany and 3 more
- Volunteers
- 36 people
- Sponsor
- Regeneron Pharmaceuticals
Telomere Biology Disorders, Dyskeratosis Congenita
Nucleoside Therapy in Patients With Telomere Biology Disorders
The goal of this clinical trial is to learn if a combination therapy of deoxycytidine (dC) plus deoxythymidine (dT) is safe in patients with telomere biology disorders.
- Conditions
- Telomere Biology Disorders, Dyskeratosis Congenita, Revesz Syndrome, Hoyeraal Hreidarsson Syndrome
- Trial name
- NCT06817590
- Testing
- deoxycytidine, deoxythymidine
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Suneet Agarwal
Anesthesia
Oral Dexmedetomidine in Pediatric MRI
The objective of this preliminary study is to assess the utility of oral dexmedetomidine as the sole sedative agent in pediatric population undergoing MRI.
- Trial name
- NCT05619627
- Testing
- Dexmedetomidine, General Anesthesia (control group)
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Soroush Merchant
Asthma
Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old
The primary objectives of this study are: To determine the pharmacokinetic (PK) profile of fluticasone propionate (Fp) and albuterol sulfate (ABS), delivered in combination, from a single dose of TEV-56248 (Fp and ABS multidose…
- Trial name
- NCT06290102
- Testing
- TEV-56248, Fp MDPI
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Advanced Solid Tumor
Study Of ATRN-119 In Patients With Advanced Solid Tumors
The purpose of this study is to assess the safety and effectiveness of ATRN-119 through the performance of a Phase 1/2a, open-label, safety, PK, and preliminary efficacy study of oral ATRN-119 in patients with advanced solid…
- Trial name
- ABOYA-119 (NCT04905914)
- Testing
- ATRN-119
- Where
- 7 sites in United States
- Volunteers
- 43 people
- Sponsor
- Aprea Therapeutics
Amyotrophic Lateral Sclerosis (ALS)
Personalized Antisense Oligonucleotide Therapy for Participants With TARDBP ALS
This research project entails delivery of a personalized antisense oligonucleotide (ASO) drug designed for participants with amyotrophic lateral sclerosis (ALS) due to a pathogenic variant in TARDBP.
- Trial name
- NCT07743268
- Testing
- nL-TARDB-006
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- n-Lorem Foundation
SCN2A-DEE, Epilepsy
A Clinical Trial of PRAX-222 in Pediatric Participants With Early Onset SCN2A Developmental and Epileptic Encephalopathy
The goal of this trial is to learn about the effect of PRAX-222 in pediatric participants with early onset SCN2A developmental and epileptic encephalopathy (DEE), aged 2 to 18 years.
- Trial name
- NCT05737784
- Testing
- PRAX-222 - Initial Dose, PRAX-222 - Initial Ascending Doses, PRAX-222 - Optional Ascending Doses
- Where
- 3 sites in United States, Brazil
- Volunteers
- 60 people
- Sponsor
- Praxis Precision Medicines
Diffuse Intrinsic Pontine Glioma, High Grade Glioma
C7R-GD2.CAR T Cells for Patients With GD2-expressing Brain Tumors (GAIL-B)
In this study, there are two treatment groups called Cohort 1 and Cohort 2. Cohort 1 is for patients with diffuse midline glioma, diffuse intrinsic pontine glioma, medulloblastoma, or another rare high-grade glioma that expresses…
- Conditions
- Diffuse Intrinsic Pontine Glioma, High Grade Glioma, Embryonal Tumor, Ependymal Tumor
- Trial name
- NCT04099797
- Testing
- C7R-GD2.CART cells (IV and ICV infusion)
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Baylor College of Medicine
Crohn Disease
Low Dose IL-2 for the Treatment of Crohn's Disease
The purpose of this study is to determine the safety and maximum effective dose (MED) of Interleukin-2 in subjects with moderate-to-severe crohn's disease.
- Trial name
- NCT04263831
- Testing
- Interleukin-2 (aldesleukin).
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Boston Children's Hospital
Adipocytic Neoplasm, Liposarcoma
NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
The study participant has been diagnosed with non-rhabdomyosarcoma (NRSTS). Primary Objectives Intermediate-Risk To estimate the 3-year event-free survival for intermediate-risk patients treated with ifosfamide, doxorubicin…
- Conditions
- Adipocytic Neoplasm, Liposarcoma, Atypical Fibroxanthoma, Angiomatoid Fibrous Histiocytoma
- Trial name
- NCT06239272
- Testing
- Surgical resection, Proton beam radiation therapy, Pazopanib
- Where
- 7 sites in United States
- Volunteers
- 139 people
- Sponsor
- St. Jude Children's Research Hospital
Leber Congenital Amaurosis, LCA
Study of Subretinally Injected ATSN-101 Administered in Patients With Leber Congenital Amaurosis Caused by Biallelic Mutations in GUCY2D
Primary Objective: To evaluate the safety and tolerability of ascending doses of ATSN-101 administered as a unilateral subretinal injection in patients with Leber Congenital Amaurosis (LCA) caused by autosomal recessive guanylate…
- Conditions
- Leber Congenital Amaurosis, LCA, LCA1
- Trial name
- NCT03920007
- Testing
- ATSN-101, ATSN-101 Diluent Solution, Prednisone
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Atsena Therapeutics Inc.
Congenital Cytomegalovirus Infection
A Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus
This is a Phase 1 single-arm open-label study of letermovir in neonates with symptomatic congenital Cytomegalovirus (CMV) disease. There will be two groups enrolled. Group 1 will be comprised of 4 subjects.
- Trial name
- NCT06118515
- Testing
- Letermovir
- Where
- 3 sites in United States
- Volunteers
- 3 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
High-grade Glioma, Medulloblastoma
Atovaquone Combined With Radiation in Children With Malignant Brain Tumors
The goal of this interventional study is to Assess the safety and tolerability of atovaquone in combination with standard radiation therapy (RT) for the treatment of pediatric patients with newly diagnosed pediatric high-grade…
- Conditions
- High-grade Glioma, Medulloblastoma, Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant
- Trial name
- AflacBT2303 (NCT06624371)
- Testing
- Atovaquone, Radiation Therapy
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Emory University
Juvenile Idiopathic Arthritis (JIA)
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis
This is a study to evaluate pharmacokinetics, safety and tolerability of upadacitinib in pediatric participants with polyarticular course juvenile idiopathic arthritis.
- Trial name
- SELECT-YOUTH (NCT03725007)
- Testing
- Upadacitinib
- Where
- 35 sites in United States, Canada and 8 more
- Volunteers
- 124 people
- Sponsor
- AbbVie
Retinitis Pigmentosa, Leber Congenital Amaurosis
Study to Assess the Safety and Efficacy of OCU400 for Retinitis Pigmentosa and Leber Congenital Amaurosis
This is a Phase 1/2 Study to Assess the Safety and Efficacy of OCU400 in patients with retinitis pigmentosa associated with NR2E3 and RHO mutations and in patients with LCA due to mutation(s) in CEP290 gene (OCU400-101).
- Trial name
- NCT05203939
- Testing
- OCU400 Low Dose, OCU400 Med Dose, OCU400 High Dose
- Where
- 7 sites in United States
- Volunteers
- 22 people
- Sponsor
- Ocugen
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