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# [[WHO]] visit
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-
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- # REALISE study registration
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- ## Our first, and biggest, clinic trial is registered
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- #+BEGIN_VERSE
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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 the REALISE study (Real world Evaluation of an ALbendazol-Ivermectin coformulation Safety and Effectiveness), an ambitious clinical trial, has been approved for publication in clinicaltrials.gov and the Pan African Clinical Trial Registry.
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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.
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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.
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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.
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If you want to review the full protocol, please visit the REALISE study's page at clinicaltrials.gov or PACTR.
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#+END_VERSE
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- #
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- # The REALISE clinical trial is registered
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At STOP2030, we aim to provide a pharmacological tool that aids in achieving the WHO's goals for
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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](https://urldefense.com/v3/__https:/clinicaltrials.gov/study/NCT06282315__;!!MxJ9VFnHG7aJbmI!WQUMYoZBne-RmarvmmdxDOX3YMCZphl_SYR6TtQ550bOR1NSAz-QDjW71W8gqwBGC7emXh7iATor5zncW8CTAdM$) and
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the [Pan African Clinical Trial
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Registry](https://urldefense.com/v3/__https:/pactr.samrc.ac.za/Search.aspx__;!!MxJ9VFnHG7aJbmI!WQUMYoZBne-RmarvmmdxDOX3YMCZphl_SYR6TtQ550bOR1NSAz-QDjW71W8gqwBGC7emXh7iATor5zncACmxOT0$) (id number PACTR202402529220760). This news follows the
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approval from the Ghana Health Service Ethical Review Committee, obtained in
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December, 2023.
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This randomized control trial is a
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Cohort Event Monitoring study designed to evaluate the safety and effectiveness
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of our fixed-dose coformulation (FDC) of albendazole and ivermectin in large
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populations, compared to the standard dose of albendazole currently used
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against STH. We plan to recruit around 20,000 school-aged children between 5
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and 17 years old in Kenya and Ghana, starting in July 2024.
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The general goals of the REALISE
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study are to validate the benefits of the FDC through this pragmatic trial
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within the context of a mass drug administration (MDA) program, to evaluate
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safety as a primary endpoint, and effectiveness profile as a secondary
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endpoint, in a large population of school-aged children.
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The clinical trial will have two
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arms, randomized by school. One arm will receive a single dose of the
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fixed-dose coformulation tablet (alb 400mg/ivm 9mg for children between 5 and
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14 years old; alb 400mg/ivm 18mg for those aged 15-17), while the other arm,
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serving as an active control group, will receive a single dose of albendazole
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400mg, the current standard.
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If you want to review the full
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protocol, please visit the REALISE study's page on [clinicaltrials.gov](https://urldefense.com/v3/__http:/clinicaltrials.gov/__;!!MxJ9VFnHG7aJbmI!WQUMYoZBne-RmarvmmdxDOX3YMCZphl_SYR6TtQ550bOR1NSAz-QDjW71W8gqwBGC7emXh7iATor5zncV4ibvmQ$) or PACTR (trial id:
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PACTR202402529220760). |