NCT05857163

Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection

Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Rifasutenizol (TNP 2198) in Combination With Rabeprazole and Amoxicillin in the Primary Treatment of Participants With H. Pylori Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 700 (actual)
• Sponsor: TenNor Therapeutics (Suzhou) Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 Rifasutenizol placebo capsules (control group) for 14 consecutive days. carbon-13 (13C) UBT will be performed 4-6 weeks after the last dose to evaluate the eradication effect of H. pylori.

Conditions

• H.Pylori Infection

Interventions

Type	Name	Description
DRUG	Rifasutenizol capsules	400 mg, BID, taken orally within half an hour after breakfast and dinner.
DRUG	Rabeprazole sodium enteric-coated tablets	20 mg, BID, taken orally within half an hour before breakfast and dinner.
DRUG	Amoxicillin Capsules	1 g, BID, taken orally within half an hour after breakfast and dinner.
DRUG	Clarithromycin placebo tablets	BID, taken orally within half an hour after breakfast and dinner.
DRUG	Bismuth potassium citrate placebo capsules	BID, taken orally within half an hour before breakfast and dinner.
DRUG	Clarithromycin tablets	500 mg, BID, taken orally within half an hour after breakfast and dinner.
DRUG	Bismuth potassium citrate capsules	240 mg, BID, taken orally within half an hour before breakfast and dinner.
DRUG	Rifasutenizol placebo capsules	BID, taken orally within half an hour before breakfast and dinner.

Timeline

• Start date: 2023-05-18
• Primary completion: 2023-12-24
• Completion: 2024-03-26
• First posted: 2023-05-12
• Last updated: 2025-08-17
• Results posted: 2025-08-17

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study