|
|
# [[WHO]] visit
|
|
|
-
|
|
|
- # REALISE study registration
|
|
|
- ## Our first, and biggest, clinic trial is registered
|
|
|
- #+BEGIN_VERSE
|
|
|
At STOP2030 we want to provide a pharmacological tool that helps at delivering WHO's goals for soil-transmitted helminthiasis (STH). That is why we're happy to announce that we've completed the design of the REALISE study (Real world Evaluation of an ALbendazol-Ivermectin coformulation Safety and Effectiveness) and taht has been approved for publication in clinicaltrials.gov and the Pan African Clinical Trial Registry.
|
|
|
|
|
|
This clinical trial is a Cohort Event Study aimed at evaluating the safety and effectiveness of our fixed-dose coformulation (FDC) of albendazol and ivermectin within large populations, matched against the standard dose albendazole currently in use against STH. We expect to recruit around 20 thousand school-aged children between 5 and 17 years old in Kenya and Ghana.
|
|
|
|
|
|
The general objectives of the REALISE study are to validate the benefits of the FDC through this pragmatic trial in the context of a mass drug administration (MDA) programme to evaluate the safety as a primary endpoint and effectiveness profile as a secondary endpoint, in a large population of school-aged children.
|
|
|
|
|
|
The clinical trial will have two arms, randomized by school. One arm will receive a single dose of the fixed-dose coformulation tablet (alb 400mg/ivm 9mg for children between 5 and 14 years old, alb 400mg/ivm 18mg for 15-17s), while the other, acting as an active control group, will receive a single dose of albendazole 400mg.
|
|
|
|
|
|
If you want to review the full protocol, please visit the REALISE study's page at clinicaltrials.gov or PACTR.
|
|
|
|
|
|
#+END_VERSE
|
|
|
- ## The REALISE clinical trial is registered
|
|
|
- #+BEGIN_VERSE
|
|
|
At STOP2030, we aim to provide a pharmacological tool that aids in achieving the WHO's goals for soil-transmitted helminthiasis (STH) by 2030. That's why we are thrilled to announce that the REALISE study (Real world Evaluation of an ALbendazol-Ivermectin coformulation Safety and Effectiveness), our most ambitious clinical trial yet, has been registered on clinicaltrials.gov and the Pan African Clinical Trial Registry (id number PACTR202402529220760).
|
|
|
|
|
|
This randomized control trial is a Cohort Event Monitoring study designed to evaluate the safety and effectiveness of our fixed-dose coformulation (FDC) of albendazole and ivermectin in large
|
|
|
populations, compared to the standard dose of albendazole currently used against STH. We plan to recruit around 20,000 school-aged children between 5 and 17 years old in Kenya and Ghana, starting the the second semester of 2024.
|
|
|
|
|
|
The general goals of the REALISE study are to validate the benefits of the FDC through this pragmatic trial within the context of a mass drug administration (MDA) program, to evaluate safety as a primary endpoint, and effectiveness profile as a secondary endpoint, in a large population of school-aged children.
|
|
|
|
|
|
The clinical trial will have two arms, randomized by school. One arm will receive a single dose of the fixed-dose coformulation tablet (alb 400mg/ivm 9mg for children between 5 and 14 years old; alb 400mg/ivm 18mg for those aged 15-17), while the other arm, serving as an active control group, will receive a single dose of albendazole 400mg, the current standard.
|
|
|
|
|
|
If you want to review the full protocol, please visit the REALISE study's page on clinicaltrials.gov or PACTR (trial id: PACTR202402529220760).
|
|
|
#+END_VERSE |