Clinical trials: Children Under 2 Years
Sickle Cell Disease
PASS of Xromi Comparing Safety and Effectiveness in Children Under 2 Years With Sickle Cell Disease [PRECISE PASS]
This post-authorisation safety and efficacy study (PRECISE PASS) evaluates the use of Xromi® (hydroxycarbamide 100 mg/mL oral solution) in children aged 9 months to under 2 years with sickle cell disease (SCD).
- Trial name
- PRECISE (NCT06923111)
- Testing
- Xromi
- Where
- 12 sites in Germany, United Kingdom
- Volunteers
- 180 people
- Sponsor
- Nova Laboratories Limited
Atopic Dermatitis (AD)
A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis
To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD)
- Trial name
- NCT07184645
- Testing
- OPA-15406, Vehicle
- Where
- Japan
- Volunteers
- 198 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Venous Thromboembolism, Children Under 2 Years
A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolism (VTE)
This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in children under 2 years old with venous thromboembolism (VTE).
- Trial name
- XAPAEDUS (NCT05900388)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Standard of care (SOC)
- Where
- 4 sites in Denmark, France and 2 more
- Volunteers
- 850 people
- Sponsor
- Bayer
Rhinitis, Allergic, Perennial
Cetirizine Placebo Controlled Study For Perennial Allergic Rhinitis
Study objective is to verify the superiority of CTZ DS to the placebo groups in the change of total nasal symptom score (TNSS) over the total treatment period from the score of the baseline assessment period.
- Trial name
- NCT00490204
- Testing
- Cetirizine
- Where
- 28 sites in Japan
- Volunteers
- 239 people
- Sponsor
- GlaxoSmithKline
Arterial Hypertension, Pulmonary
A Study of Macitentan in Children Below 2 Years of Age
The purpose of this study is to learn what happens to macitentan and its active metabolite (aprocitentan) in the body of children aged between 1 month and 2 years.
- Trial name
- NCT05731492
- Testing
- Macitentan
- Where
- 4 sites in Germany, Poland
- Sponsor
- Actelion
Venous Thromboembolism
A Study in Europe Based on Medical Records That Looks at the Safety of Dabigatran in Children Below 2 Years of Age Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot
The study is designed to collect and evaluate Dabigatran Etexilate (DE) safety in the context of routine anticoagulation care provided in the European Union (EU)/European Economic Area (EEA) for children under 2 years of age.
- Trial name
- DaPaR (NCT05536791)
- Testing
- Dabigatran Etexilate (DE)
- Where
- 6 sites in Germany, Netherlands and 2 more
- Sponsor
- Boehringer Ingelheim
Primary Immune Deficiency
Retrospective Chart Review of Subcutaneous IgG Use in Infants
This study is a retrospective chart review of the use of subcutaneous IgG (SCIG) in infants less than two years old.
- Trial name
- NCT01166074
- Testing
- Subcutaneous IgG (SCIG)
- Where
- 5 sites in United States
- Volunteers
- 27 people
- Sponsor
- CSL Behring
Hyperkalemia
Effect of Patiromer in Children Under 12 Years of Age With High Blood Potassium Levels
A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia.
- Trial name
- EMERALD2 (NCT05766839)
- Testing
- Patiromer
- Where
- 37 sites in United States, Australia and 13 more
- Volunteers
- 36 people
- Sponsor
- Vifor Pharma, Inc.