Clinical trials: Safety
Acute Lymphoblastic Leukemia
CD19/CD22 CAR-T Cell Therapy in MRD-Positive B-lineage Acute Lymphoblastic Leukemia in Children.
In this study, CD19/CD22 dual-target CAR-T therapy will be carried out among children patients who are still positive after induction remission, and subsequent chemotherapy will continue after CAR-T cells exert their functions.
- Trial name
- NCT06752785
- Testing
- CAR-T Therapy
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Guangzhou Women and Children's Medical Center
After-hours Care
Differentiated Access to Out-of-hours Primary Care Through Emergency Access
The purpose of this randomized controlled trial is to test the use of an emergency button that allows patients to jump the telephone waiting line at the out-of-hours primary care in two regions in Denmark if they perceive their…
- Trial name
- Akutknappen (NCT02572115)
- Testing
- Akutknappen - used, Akutknappen - not used
- Where
- Denmark
- Volunteers
- 7,385 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Adverse Drug Reaction (ADR)
National Active Surveillance Network and Pharmacogenomics of Adverse Drug Reactions in Children
The purpose of the study is (1) to identify and collect samples from children and adults who take drugs and have adverse drug reactions AND children and adults who take drugs and do not experience any adverse drug effects; (2) to…
- Trial name
- NCT00414115
- Where
- Canada
- Volunteers
- 7,000 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
Primary Immune Deficiency
Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency
The purpose of this study is to evaluate the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects with Primary Humoral Immunodeficiency (PHID).
- Trial name
- NCT04565015
- Testing
- GC5107
- Where
- 8 sites in United States, Bosnia and Herzegovina and 1 more
- Volunteers
- 24 people
- Sponsor
- GC Biopharma Corp
Infections, Meningococcal
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Conjugate Vaccine (GSK134612) When Co-administered With Boostrix® in Subjects Between 11 and 25 Years of Age
The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the meningococcal conjugate vaccine (MenACWY-TT) co-administered with Boostrix® versus each of the two vaccines given separately in healthy…
- Trial name
- NCT01767376
- Testing
- Meningococcal vaccine GSK134612, Boostrix®
- Where
- 15 sites in Dominican Republic, Germany and 1 more
- Volunteers
- 692 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bronchopulmonary Dysplasia of Newborn
Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia
This is a multicenter, randomized, placebo-controlled, sequential dose-escalating, double-masked, safety study of sildenafil in premature infants (inpatient in Neonatal Intensive Care Units (NICUs)) with severe bronchopulmonary…
- Trial name
- SILDI-SAFE (NCT04447989)
- Testing
- Sildenafil
- Where
- 25 sites in United States
- Volunteers
- 125 people
- Sponsor
- Christoph Hornik
Asthma
A Compassionate Access Protocol to Assess the Safety of XolairTM (Omalizumab) in Patients (≥ 6 Years Old) With Severe Allergic Asthma Who Remain Symptomatic Despite Optimal Therapy
This study has the objective of providing compassionate use access to omalizumab (Xolair) and to evaluate the Safety of Xolair in subjects with severe allergic asthma who remain symptomatic despite optimal therapy according to…
- Trial name
- NCT00639691
- Testing
- omalizumab
- Where
- Canada
- Volunteers
- 48 people
- Sponsor
- Novartis
Alagille Syndrome (ALGS)
A Study of TAK-625 for the Treatment of Alagille Syndrome (ALGS)
The main aim of the study is to check if TAK-625 improves symptoms of Alagille Syndrome (ALGS), side effect from the study treatment or TAK-625, and how much TAK-625 stays in their blood over time.
- Trial name
- NCT05543174
- Testing
- TAK-625
- Where
- 8 sites in Japan
- Volunteers
- 7 people
- Sponsor
- Takeda
Ornithine Transcarbamylase Deficiency
Halting Ornithine Transcarbamylase Deficiency With Recombinant AAV in ChildrEn
Ornithine transcarbamylase deficiency (OTCD) is an inherited metabolic liver disease which means that the body cannot maintain normal levels of ammonia.
- Trial name
- HORACE (NCT05092685)
- Testing
- AAVLK03hOTC
- Where
- United Kingdom
- Volunteers
- 12 people
- Sponsor
- University College, London
Congenital Hyperinsulinism
RZ358 Treatment for Congenital Hyperinsulinism
The Phase 3 pivotal study is designed to evaluate the efficacy and safety of RZ358 for the treatment of congenital hyperinsulinism (HI) as add-on to standard-of-care (SOC) therapy compared to SOC alone over 24 weeks and to…
- Trial name
- sunRIZE (NCT06208215)
- Testing
- RZ358 (5-10 mg/kg) + SOC
- Where
- 18 sites in United States, Bulgaria and 11 more
- Volunteers
- 56 people
- Sponsor
- Rezolute
Autism Spectrum Disorder
VGN-Ex05e in Patients With Autism Spectrum Disorder Associated With Severe Self-Injurious and Aggressive Behaviors
To evaluate the safety and tolerability of intracerebral injection of VGN-Ex05e in the nucleus accumbens of patients with autism spectrum disorder.
- Trial name
- NCT07433517
- Testing
- VGN-Ex05e
- Volunteers
- 6 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Evaluate the Safety and Effectiveness of Mesenchymal Stem Cell Conditioned Medium-derived Pleiotropic Factor in Treating Donor Sites
Mesenchymal Stem Cell-derived Pleiotropic Factor in the Treatment of Donor Sites
Skin grafting is a standard treatment for deep wounds, but care of the donor site after transplantation is very important. The means of accelerating wound healing can increase overall patient satisfaction.
- Trial name
- NCT04234750
- Testing
- mesenchymal stem cell conditioned medium-derived pleiotropic factor
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Chinese PLA General Hospital
Candida Vulvovaginitis
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)
This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in female subjects 12 years and older with AVVC.
- Trial name
- NCT03734991
- Testing
- Ibrexafungerp
- Where
- 25 sites in United States
- Volunteers
- 376 people
- Sponsor
- Scynexis, Inc.
Epilepsy, Partial
A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy
Open-label study to allow pediatric patients who have participated in prior Levetiracetam (Keppra®) studies to continue their treatment with adequate monitoring and standardized follow-up care until Levetiracetam (Keppra®) is…
- Trial name
- NCT00150709
- Testing
- Levetiracetam
- Volunteers
- 223 people
- Sponsor
- UCB Pharma
Thrombosis
Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure
The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8…
- Trial name
- UNIVERSE (NCT02846532)
- Testing
- Rivaroxaban, Acetylsalicylic Acid
- Where
- 42 sites in United States, Argentina and 8 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
Rhinitis Seasonal
Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis
Primary Objective: To evaluate the efficacy on the nasal congestion of a twice-daily fexofenadine HCl 60 mg - pseudoephedrine HCl 60 mg combination (FEX60/PSE60) and fexofenadine HCl 60 mg - pseudoephedrine HCl 120 mg combination…
- Trial name
- NCT01306721
- Testing
- fexofenadine HCL (M016455), pseudoephedrine
- Where
- 3 sites in Japan
- Volunteers
- 520 people
- Sponsor
- Sanofi
Diptheria Immunization, Tetanus Immunization
Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV
In 2012, the World Health Assembly (WHA) endorsed the proposed Polio Endgame Strategy, which includes withdrawal of the Sabin-virus type 2 antigen-responsible for an estimated 95% of vaccine derived cases of polio by replacing…
- Conditions
- Diptheria Immunization, Tetanus Immunization, Pertussis Immunization, Hepatitis B Immunization
- Trial name
- NCT06413121
- Testing
- Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV, Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV
- Where
- 11 sites in Bangladesh, India
- Volunteers
- 1,557 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Infections, Streptococcal
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine 2830930A Administered in Toddlers
The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the GSK Biologicals' pneumococcal vaccine 2830930A in toddlers aged 12 to 23 months at study entry.
- Trial name
- NCT01485406
- Testing
- Pneumococcal vaccine GSK2830930A, Synflorix™
- Where
- 4 sites in Germany
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Endometriosis, Pelvic Pain
The Safety and Effectiveness of Surgery With or Without Raloxifene for the Treatment of Pelvic Pain Caused by Endometriosis
Many women with lower abdominal pain have endometriosis. Endometriosis is a condition in which the lining of the uterus (endometrium) is found outside of the uterus. The diagnosis of endometriosis is usually made at surgery.
- Trial name
- NCT00001848
- Testing
- Raloxifene
- Where
- United States
- Volunteers
- 612 people, healthy volunteers welcome
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
Phase 2 Study to Assess the Safety and Efficacy of ANG003
In this study, ANG003, a pancreatic enzyme replacement therapy (PERT; commonly called "enzymes"), is being investigated as a potential treatment for exocrine pancreatic insufficiency (EPI).
- Trial name
- NCT07450547
- Testing
- ANG003 Dose A, ANG003 Dose B, Creon
- Where
- 28 sites in United States
- Volunteers
- 113 people
- Sponsor
- Anagram Therapeutics, Inc.
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