Clinical trials: Dose-Finding Study
Postoperative Nausea and Vomiting, Postoperative Pain
Dexamethasone for Paediatric Adeno-tonsillectomy - A Dose-finding Study
Adeno-tonsillectomy is a commonly performed surgical procedure in children. Main morbidities are postoperative pain, nausea and vomiting, and haemorrhage.
- Trial name
- NCT00403806
- Testing
- dexamethasone, Saline
- Where
- Switzerland
- Volunteers
- 215 people, healthy volunteers welcome
- Sponsor
- University Hospital, Geneva
Glioblastoma, Rhabdomyosarcomas
ZD1839 and Oral Irinotecan in Treating Young Patients With Refractory Solid Tumors
The purpose of this Phase I study is to find the largest dose of the drug irinotecan, in combination with ZD1839, that can be given safely to children and to learn the good and bad effects.
- Conditions
- Glioblastoma, Rhabdomyosarcomas, Neuroblastoma, Osteosarcoma
- Trial name
- NCT00132158
- Testing
- Irinotecan (Camptosar), Gefitinib (Iressa)
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- St. Jude Children's Research Hospital
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors
This trial is conducted in Asia, Europe, Japan and North America. The aim of this clinical trial is to investigate the safety and the efficacy of a prophylactic treatment option with long acting coagulation factor VII (LA-rFVIIa)…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- NCT00951405
- Testing
- activated recombinant human factor VII, long acting
- Where
- 25 sites in United States, Brazil and 9 more
- Volunteers
- 23 people
- Sponsor
- Novo Nordisk A/S
Fabry Disease
Evaluate the Safety and Preliminary Efficacy of EXG110 in Subjects With Fabry Disease
Objective: To explore the safety and tolerability of different doses of EXG110 with Fabre disease
- Trial name
- NCT06539624
- Testing
- EXG110 injection
- Where
- 2 sites in China
- Volunteers
- 12 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Schistosomiasis, Schistosomiasis Mansoni
Praziquantel in Children Under Age 4
The overall goals of this proposal are to conduct a trial to address the significant gaps with respect to our understanding of best approaches to treatment of children ages 1-4 with intestinal schistosomiasis.
- Conditions
- Schistosomiasis, Schistosomiasis Mansoni, Schistosoma Japonicum Infection
- Trial name
- PIP (NCT03640377)
- Testing
- Praziquantel
- Where
- 2 sites in Uganda, United Kingdom
- Volunteers
- 354 people, healthy volunteers welcome
- Sponsor
- Rhode Island Hospital
Cryptococcal Meningitis, HIV Infections
High-Dose Fluconazole for the Treatment of Cryptococcal Meningitis in HIV-Infected Individuals
Cryptococcal meningitis (CM) is an infection of the membranes covering the brain and spinal cord, caused by the fungus Cryptococcus neoformans.
- Trial name
- NCT00885703
- Testing
- Fluconazole, Amphotericin B
- Where
- 10 sites in United States, India and 6 more
- Volunteers
- 168 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Neuroectodermal Tumors, Primitive, Liver Neoplasms
NAC to Prevent Cisplatin-induced Hearing Loss
Cisplatin is a key chemotherapy agent for the treatment of multiple childhood cancers but causes permanent hearing loss. This study investigates the drug N-acetylcysteine (NAC) to determine the dose necessary to protect hearing…
- Conditions
- Neuroectodermal Tumors, Primitive, Liver Neoplasms, Osteosarcoma, Other Childhood Cancers Using Cisplatin-based Regimens
- Trial name
- NCT02094625
- Testing
- N-Acetylcysteine
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Children's Hospital Los Angeles
Childhood Absence Epilepsy, Juvenile Absence Epilepsy
A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
The purpose of the study is to test the efficacy, safety and tolerability of brivaracetam monotherapy in study participants 2 to 25 years of age inclusive with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).
- Trial name
- EXPAND (NCT04666610)
- Testing
- Brivaracetam
- Where
- 35 sites in United States, Georgia and 5 more
- Volunteers
- 154 people
- Sponsor
- UCB Biopharma SRL
SARS-CoV-2 Infection, COVID-19
Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children
This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and…
- Trial name
- NCT04816643
- Testing
- Biological/Vaccine: BNT162b2 10mcg, BNT162b2 20mcg, BNT162b2 30mcg
- Where
- 128 sites in United States, Brazil and 4 more
- Volunteers
- 11,837 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Muscular Dystrophy, Duchenne
A Study to Compare Safety and Efficacy of High Doses of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) (MIS51ON)
Part 1 (dose escalation) will evaluate the safety and tolerability of 2 doses (100 milligrams/kilogram [mg/kg] and 200 mg/kg) of eteplirsen in approximately 10 participants with DMD; Part 2 (dose finding and dose comparison) will…
- Trial name
- MIS51ON (NCT03992430)
- Testing
- Eteplirsen
- Where
- 59 sites in United States, Colombia and 24 more
- Volunteers
- 160 people
- Sponsor
- Sarepta Therapeutics, Inc.
Shigellosis
A Study to Determine If a New Shigella Vaccine is Safe, Induces Immunity and The Best Dose Among Kenyan Infants
In this study, the tetravalent bioconjugate candidate vaccine Shigella4V will be tested to obtain first-in-human data on its safety and immunogenicity in infants and to identify the preferred dose of Shigella4V in 9 month old…
- Trial name
- NCT04056117
- Testing
- Shigella 4V, MenACWY, Rabies
- Where
- 2 sites in Kenya
- Volunteers
- 597 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Pediatric Oncology
A Phase I Dose Finding Study in Children With Solid Tumors Recurrent or Refractory to Standard Therapy
Dose escalation phase of the study : To define the safety profile, maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of regorafenib administered orally as a single agent in a 3-weeks-on/1- week-off schedule in…
- Trial name
- NCT02085148
- Testing
- Regorafenib (BAY73-4506), Vincristine (Cellcristin®), Irinotecan (Irinotecan Cell pharm®)
- Where
- 12 sites in France, Italy and 2 more
- Volunteers
- 62 people
- Sponsor
- Bayer
Shigella Infection
Safety and Immunogenicity Study of IP-QSV Vaccine in Healthy Adults/Adolescents, Children and Infants
The goal of this phase 1/2a, randomized, observer-blind, age-descending, dose-finding trial is to evaluate the safety and immunogenicity of a quadrivalent synthetic oligosaccharide-based Shigella vaccine (adjuvanted IP-QSV) in…
- Trial name
- NCT07666750
- Testing
- 30μg IP-QSV, 10μg IP-QSV, 2μg IP-QSV
- Volunteers
- 370 people, healthy volunteers welcome
- Sponsor
- International Vaccine Institute
Proteus Syndrome
Dose Finding Trial of MK-7075 in Children and Adults With Proteus Syndrome
Background: Proteus syndrome (PS) is caused by a mutation in the AKT1 gene. This gene makes a protein that communicates with other proteins in the body to make cells grow.
- Trial name
- NCT02594215
- Testing
- MK-7075 (miransertib)
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- National Human Genome Research Institute (NHGRI)
B-cell Acute Lymphoblastic Leukemia, Large B-cell Lymphoma
Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)
This is a Phase 1/2, first-in-human, open-label, dose-escalating trial designed to assess the safety and efficacy of VNX-101 in patients with relapsed or refractory CD19-positive hematologic malignancies.
- Conditions
- B-cell Acute Lymphoblastic Leukemia, Large B-cell Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- Trial name
- NCT06533579
- Testing
- Dose Level 1, VNX-101, Dose Level 2, VNX-101, Dose Level 3, VNX-101
- Where
- 11 sites in United States
- Volunteers
- 32 people
- Sponsor
- Vironexis Biotherapeutics Inc.
Psychosis
Dose Finding of Quetiapine Fumarate 200mg vs 400mg in First Episode Psychosis
The purpose of this study is determine the minimal effective dose and the impact on: 1. treatment outcomes at 4, 12 and/or 48 weeks the treatment has required to treat patients experiencing the first psychotic episode 2.
- Trial name
- NCT00449397
- Testing
- Quetiapine Fumarate
- Where
- Australia
- Volunteers
- 150 people
- Sponsor
- AstraZeneca
Autism Spectrum Disorders
Dose Finding Study of Pioglitazone in Children With Autism Spectrum Disorders (ASD) (PIO)
The investigators propose a pilot, single blind, placebo run-in, dose finding study of pioglitazone in children with autism with the ultimate goal of identifying appropriate dosing and outcome measures for a larger follow-up…
- Trial name
- NCT01205282
- Testing
- Pioglitazone
- Where
- Canada
- Volunteers
- 28 people
- Sponsor
- Evdokia Anagnostou
Rhinitis, Rhinoconjunctivitis
Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Grass Pollen Allergy
The purpose of the study is to evaluate the more efficient dose for the treatment of rhinitis/rhinoconjunctivitis against grass pollen allergy
- Trial name
- MG56 (NCT02654223)
- Testing
- MG56 Mannosylated 500 subcutaneous, MG56 Mannosylated 1000 subcutaneous, MG56 Mannosylated 3000 subcutaneous
- Where
- 12 sites in Spain
- Volunteers
- 180 people
- Sponsor
- Inmunotek S.L.
Travelers' Diarrhea
Dose-Finding Study of WS6788A and LSN03-016011/A Enterotoxigenic E. Coli ETEC Challenge Strains That Express CS17
This will be a strain and dose-finding study in which LSN03-016011/A ETEC will be administered at a starting inoculum of 5x108 cfu to 5 subjects to establish a human disease model.
- Trial name
- NCT00564577
- Testing
- CFA/I and CS17 challenge strain
- Where
- 2 sites in United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Peanut Allergy
Oral Immunotherapy for Peanut Allergic Patients
Multicenter, double-blind, randomized, placebo-controlled phase I/II study to determine the safety, tolerability, potential efficacy and dose finding of INP20, an oral immunotherapy in peanut-allergic patients.
- Trial name
- NCT04163562
- Testing
- INP20
- Where
- 2 sites in Spain
- Volunteers
- 50 people
- Sponsor
- InnoUp Farma S.L.