Efficacy and Safety of Rifasutenizol (TNP 2198) in Participants With H. Pylori Infection
Status:
Not yet recruiting
Trial end date:
2024-10-30
Target enrollment:
Participant gender:
Summary
A multi-center, randomized, double-blind, bismuth-containing quadruple active
comparator-controlled Phase 3 clinical study to evaluate the efficacy and safety of
Rifasutenizol in combination with rabeprazole and amoxicillin in the primary treatment of
participants with H. pylori infection using an adaptive design with sample size
re-estimation.
Subjects will be randomly assigned to test group or control group at a 1:1 ratio stratified
by study site, and will receive Rifasutenizol capsules, rabeprazole sodium enteric-coated
tablets, amoxicillin capsules combined with clarithromycin placebo tablets and bismuth
potassium citrate placebo capsules (test group), or bismuth-containing quadruple regimen of
amoxicillin capsules, clarithromycin tablets, rabeprazole sodium enteric-coated tablets and
bismuth potassium citrate capsules combined with RSZ placebo capsules (control group) for 14
consecutive days.
13C UBT will be performed 4 6 weeks after the last dose to evaluate the eradication effect of
H. pylori.