Clinical trials: Drug Safety
Kidney Failure, Chronic, Kidney Transplantation
Safety of Immunosuppression Minimization in Children and Adolescents After Kidney Transplantation
Kidney transplantation is widely considered to be the treatment of choice for children with End Stage Renal Disease (ESRD). The purpose of this study is to determine the safety of sirolimus monotherapy for long-term…
- Conditions
- Kidney Failure, Chronic, Kidney Transplantation, Immunosuppression
- Trial name
- NCT00768729
- Testing
- Sirolimus, MMF or Azathioprine
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Allergic Conjunctivitis
Evaluation of Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens in Allergic Conjunctivitis
The purpose of this study is to evaluate the efficacy and safety of an anti-allergy drug with a contact lens compared to placebo in preventing ocular itching associated with allergic conjunctivitis
- Trial name
- NCT00432757
- Testing
- Ketotifen with a Contact Lens (generic name not yet established)
- Where
- 3 sites in United States
- Volunteers
- 120 people
- Sponsor
- Vistakon Pharmaceuticals
Lyme Disease, Healthy
Lyme Disease Diagnostic Assay - Collection of Whole Blood
The primary objective is to obtain whole blood from subjects with signs and/or symptoms of early Borrelisois. Whole blood will also be obtained from subjects with suspicion of acute Borreliosis and under medical examination for…
- Trial name
- NCT05041595
- Testing
- Lyme diagnostic assay
- Where
- United States
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- DiaSorin Inc.
Allergic Reaction (IgA) Vasculitis
Evaluate the Effectiveness and Safety of BBD-1 Multi-target Immune Enhancement Targeting Agent in the Treatment of Hypersensitivity Reaction (IgA) Vasculitis
Hypersensitivity (IgA) vasculitis is a common vascular allergic disease, the cause of which is not yet clear, and may involve infection, immune disorders, heredity and other factors. It belongs to the category of immune diseases.
- Trial name
- NCT07595367
- Testing
- BBD-1 Multi target Immune Enhancement Targeting Agent
- Where
- 2 sites in United States, China
- Volunteers
- 30 people
- Sponsor
- Qifeng Zhang
HIV Infections
Trial to Evaluate Steady State Pharmacokinetic Parameters, Efficacy and Safety of Nevirapine in Antiretroviral Drug naïve Pediatric Patients
Trial to evaluate steady state pharmacokinetic parameters of nevirapine 150mg/m2 and nevirapine 4 or 7 mg/kg after 4 weeks, and efficacy and safety of the dosing when administered for 48 weeks in antiretroviral drug naïve…
- Trial name
- NCT00273975
- Testing
- Nevirapine, Lamivudine, Zidovudine
- Where
- 4 sites in South Africa
- Volunteers
- 123 people
- Sponsor
- Boehringer Ingelheim
Safety Issues, Effect of Drugs
The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells
To study the safety and effect of autologous umbilical cord blood stem cells for treatment brain injury
- Trial name
- NCT03696745
- Testing
- autologous umbilical cord blood stem cells, 0.9% Sodium-chloride
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Guangdong Women and Children Hospital
Hemophilia A
A Study to Test a Medicine (Fitusiran) for Preventing Bleeds in People With Severe Hemophilia Who Previously Received Preventive Treatment With Emicizumab
This is an exploratory, single group, Phase 4, study to assess treatment with fitusiran prophylaxis after switching from emicizumab prophylaxis.
- Trial name
- NCT06145373
- Testing
- Fitusiran (SAR439774), Clotting factor concentrates (CFC) or bypassing agents (BPA), Antithrombin concentrate (ATIIIC)
- Where
- 3 sites in United States, Taiwan
- Volunteers
- 20 people
- Sponsor
- Sanofi
Fungal Infections
Safety and Efficacy of Posaconazole Oral Suspension in Usual Practice in Korea (P08547)
This study will examine the safety and efficacy of posaconazole in general use in Korea. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its…
- Trial name
- NCT01436578
- Testing
- Posaconazole oral suspension 40 mg/mL
- Volunteers
- 273 people
- Sponsor
- Merck Sharp & Dohme LLC
Atopic Dermatitis
Safety Study Evaluating the Adrenal Suppression Potential of Product 0405 in Pediatric Subjects With Atopic Dermatitis
The aim of the trial is to assess Adrenal Suppression potential when pediatric subjects are administered Product 0405 for the treatment of Atopic Dermatitis
- Trial name
- 0405-01-04 (NCT01232543)
- Testing
- Product 0405
- Where
- United States
- Volunteers
- 114 people
- Sponsor
- Fougera Pharmaceuticals Inc.
Autoimmune Diseases
Safety and Efficacy Study of Regulatory T Cells in Treating Autoimmune Hepatitis
Separated and expanded the CD4+CD25+CD127- Tregs from peripheral blood of autoimmune hepatitis patients and administrate the cells (5 x 106 cells/kg) into patients.
- Trial name
- Treg (NCT02704338)
- Testing
- Regulatory T cells
- Volunteers
- 30 people
- Sponsor
- Nanjing Medical University
Atopic Dermatitis
Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Halobetasol Spray in Patients With Atopic Dermatitis
This is an open-label, safety study designed to assess the multiple-dose pharmacokinetics and potential for adrenal suppression following topical treatment with halobetasol propionate 0.05% spray applied twice-daily in adult…
- Trial name
- NCT03245385
- Testing
- Treatment with Halobetasol propionate 0.05% topical spray
- Where
- 13 sites in United States
- Volunteers
- 20 people
- Sponsor
- Sun Pharmaceutical Industries Limited
COVID-19 SARS-CoV-2 Infection
A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease
The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease.
- Trial name
- NCT06679140
- Testing
- ibuzatrelvir
- Where
- 256 sites in United States, Argentina and 17 more
- Volunteers
- 2,330 people
- Sponsor
- Pfizer
Healhty
Effectiveness of Artificial Intelligence Integrated Mixed Reality-based High-Alert Medications Management Simulation Program
The goal of this clinical trial is to learn if a Artificial Intelligence integrated Mixed Reality-based High-Alert Medications Management Simulation Program (AIMR-HAM) helps hospital nurses manage high-alert medicines (HAMs) more…
- Trial name
- AIMR-HAM (NCT07390461)
- Testing
- Artificial Intelligence integrated Mixed Reality-based Simulation Program, Standard medication-management education
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Chonnam National University Hospital
Invasive Fungal Infection
Voriconazole Trough Plasma Levels : Genetic Polymorphism, Efficacy, Safety in Patients With Hematologic Malignancy
Multiple factors are associated with a large variability in voriconazole exposure following standard dose administration, such as non-linear saturable pharmacokinetics, drug-drug interactions, liver disease, patient age, and…
- Trial name
- NCT01148160
- Testing
- voriconazole
- Where
- South Korea
- Volunteers
- 10 people
- Sponsor
- Asan Medical Center
Migraine Disorders
Migraine Study in Adolescent Patients
This study was designed to determine how well the combination medication, sumatriptan and naproxen sodium, treats migraine headache in adolescents 12-17 years old
- Trial name
- NCT00843024
- Testing
- Sumatriptan and Naproxen Sodium
- Where
- 79 sites in United States
- Volunteers
- 589 people
- Sponsor
- GlaxoSmithKline
Adverse Drug Event, Potential Adverse Drug Event, and Quality Measures
Emergency Pharmacist Safety Study
The Emergency Department (ED) is a unique environment in medicine, and many safety mechanisms used in other hospital settings cannot be applied in the ED.
- Trial name
- NCT00382434
- Testing
- presence of an emergency pharmacist in the ED
- Where
- United States
- Volunteers
- 10,224 people
- Sponsor
- University of Rochester
Adverse Reaction to Other Drugs and Medicines
5-HT3 Antagonists (Antiemetics) and Cardiac Safety
5-HT3 antagonists (ondansetron) are highly effective medications for the treatment of nausea and vomiting. However, these medications also associated with potentially severe and life-threatening cardiac adverse drug reactions…
- Trial name
- NCT02436798
- Testing
- Ondansetron
- Where
- Canada
- Volunteers
- 266 people
- Sponsor
- University of British Columbia
Cerebral Palsy (CP)
Double-blind Comparative Randomized Multicenter
The name of the study: is a double-blind comparative randomized trial to evaluate the safety and efficacy of the drug Miotox® with the participation of children with cerebral palsy The code/number of the Protocol No.
- Trial name
- NCT06840158
- Testing
- Miotox (Botulinum toxin type A is a hemagglutinin complex), BOTOX®
- Where
- 3 sites in Russia
- Volunteers
- 80 people
- Sponsor
- Innopharm LLC
Mycobacterium Avium-intracellulare Infection, HIV Infections
The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex (MAC) Infections in Children With AIDS
To evaluate three doses of clarithromycin in children with AIDS and Mycobacterium avium complex (MAC) infection who are receiving concurrent antiretroviral therapy.
- Trial name
- NCT00000971
- Testing
- Clarithromycin, Zidovudine, Didanosine
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Abbott
Central Nervous System
Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs
This study is designed to evaluate the pharmacokinetics, efficacy, and safety of perampanel oral suspension on seizure frequency in pediatric participants maintained on one to three stable antiepileptic drugs
- Trial name
- NCT01527006
- Testing
- perampanel
- Where
- 23 sites in United States
- Volunteers
- 63 people
- Sponsor
- Eisai Inc.