Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With… (NCT05857163) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection
China700 participantsStarted 2023-05-18
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Voluntarily sign the informed consent form.
* Age 18-65 years (inclusive), male or female.
* The result of 13C-UBT is positive (≥ 4 Delta Over Baseline), and the infection of H. pylori are confirmed by gastroscopic biopsy histology.
* Subjects agree to refrain from taking any antibiotics or traditional Chinese medicines with antibacterial effect, bismuth, and antacids (such as proton pump inhibitor, H2 receptor blocker, P-CAB) other than the study drugs during the Screening Period until the end of the study (Visit 5, i.e., Efficacy Evaluation Visit).
* Subjects and their heterosexual partners must agree to have no pregnancy plan and voluntarily take effective contraceptive measures during the trial and for at least 6 months after the end of the study medication.
* Willing to follow and able to complete all trial procedures.
Exclusion Criteria:
* Allergy to any of the study drugs (rabeprazole, amoxicillin, clarithromycin, bismuth potassium citrate), allergic constitution (multiple drug and food allergies); or any contraindication to the use of rifamycin, nitroimidazoles or study drugs.
* History of H. pylori eradication therapy (including participation in other clinical trials for H. pylori eradication).
* Subjects with confirmed tuberculosis (TB) or Mycobacterium avium complex (MAC) infection or a history of TB or MAC infection.
* History of dysphagia or any gastrointestinal disorder affecting drug absorption.
* History of obstruction pyloric; or exce…
What they're measuring
1
Eradication Rate of H.Pylori Infection
Timeframe: 4 to 6 weeks after the last dose of the study drugs