Search Bar & Filters
Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are investigating the effects of crizanlizumab compared to a placebo in adolescents and adults with Sickle Cell Disease who experience frequent vaso-occlusive crises VOCs. This Phase III, randomized, double-blind study involves patients aged 12 years and older who have had 4 to 12 VOCs managed by healthcare professionals in the past year. The study evaluates the safety and effectiveness of crizanlizumab with or without standard hydroxyureahydroxycarbamide therapy. Participants are randomly assigned in a 21 ratio to receive either crizanlizumab at a dose of 5 mgkg or a placebo, both given alongside standard care. The treatment is administered intravenously as a concentrate for infusion. The study is stratified by hydroxyurea use and geographical region to ensure balanced groups. The main treatment period lasts for one year. During the study, participants will attend regular visits for treatment and monitoring. Researchers will assess the number of healthcare-managed VOCs, including those treated in person or via remote consultation, and measure various other outcomes such as time to first VOC, VOC duration, antibody development to crizanlizumab, adverse events, and changes in hemoglobin levels. Safety and efficacy will be observed over two years, with detailed documentation of VOC events and other health assessments throughout participation.
Actively Recruiting
Researchers are evaluating how well different anti-malarial drugs work and how safe they are for treating uncomplicated Plasmodium falciparum malaria in adults, adolescents, and children. This study focuses on the parasite-killing effects and potential cure rates of these drugs when given alone or combined with others. It also looks at how the drugs are processed by the body to help decide doses for future studies. Participants will receive one of several treatments, including varying doses of the oral drug INE963, combinations of oral KAE609 Cipargamin with INE963 or KLU156, or the standard of care drug Coartem. The study has multiple parts with patients allocated randomly to different treatment groups. Dosing levels and combinations are tested to compare how effectively they clear the malaria parasite. During the study, participants will have their parasite levels monitored up to 7 days and clinical response assessed by day 29. Blood samples will be taken by day 22 to study drug levels and how the body absorbs and clears the medicines. Safety is monitored through reports of side effects until day 43. The total participation lasts through these assessments to understand treatment impact and tolerability.