H.Pylori InfectionPhase 3NCT05857163
Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection
A Phase 3 study testing Rifasutenizol capsules, Rabeprazole sodium enteric-coated tablets and Amoxicillin Capsules in people with H.Pylori Infection, run by TenNor Therapeutics (Suzhou) Limited at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- H.Pylori Infection
- What is being tested?
- Rifasutenizol capsules, Rabeprazole sodium enteric-coated tablets and Amoxicillin Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2023to 26 Mar 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 excessive gastric acid secretion (such as Zollinger-Ellison syndrome).
- History of gastric cancer.
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- History of neoplasm malignant within 5 years prior to screening, with the exception of basal cell carcinoma or carcinoma cervix in situ treated without evidence of recurrence.
- History of esophageal or gastric surgery, except for simple repair of the perforated ulcer.
- History of substance abuse or drug use within 5 years prior to screening.
- Alcohol abuse or a history of alcohol abuse within 5 years prior to screening (average weekly consumption of ≥ 14 units of alcohol: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine/Chinese rice wine/rice wine);
- Presence of active gastric and/or duodenal ulcer.
- Anticoagulant therapy or long-term treatment with nonsteroidal anti-inflammatory drugs.
- Treatment with any other investigational new drugs within 4 weeks prior to the Screening Period.
- Any prohibited medications or non-drug therapies as specified in the protocol (see Section 10.3).
- White blood cell count or neutrophil count below the lower limit of normal range.
- Anemia (hemoglobin < 90 g/L).
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, or serum creatinine above the upper limit of normal range.
- Test positive for hepatitis B surface antigen, hepatitis C antibody, AIDS antibody, or microspironema pallidum antibody.
- Abnormal ECG with clinical significance.
- Female subjects who are pregnant, lactating, or have a positive urine pregnancy result during the Screening Period.
- Inability to communicate with the Investigator and to comply with the study requirements.
- Other conditions considered inappropriate to participate in this study by the Investigator, e.g., the subject has a history of severe central nervous system, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrine, or hematological diseases, or has clinical manifestations of these diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- Rifasutenizol capsules, Rabeprazole sodium enteric-coated tablets, Amoxicillin Capsules, Clarithromycin placebo tablets, Bismuth potassium citrate placebo capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifasutenizol capsulesDrug
Also called TNP-2198 capsules
400 mg, BID, taken orally within half an hour after breakfast and dinner.
Rabeprazole sodium enteric-coated tabletsDrug
Also called Rabeprazole
20 mg, BID, taken orally within half an hour before breakfast and dinner.
Amoxicillin CapsulesDrug
Also called Amoxicillin
1 g, BID, taken orally within half an hour after breakfast and dinner.
Clarithromycin placebo tabletsDrug
Also called Clarithromycin placebo
BID, taken orally within half an hour after breakfast and dinner.
Bismuth potassium citrate placebo capsulesDrug
Also called Bismuth placebo
BID, taken orally within half an hour before breakfast and dinner.
Clarithromycin tabletsDrug
Also called Clarithromycin
500 mg, BID, taken orally within half an hour after breakfast and dinner.
Bismuth potassium citrate capsulesDrug
Also called Bismuth
240 mg, BID, taken orally within half an hour before breakfast and dinner.
Rifasutenizol placebo capsulesDrug
Also called Rifasutenizol placebo
BID, taken orally within half an hour before breakfast and dinner.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Rifasutenizol capsules 400 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Amoxicillin capsules 1 g + Bismuth potassium citrate placebo capsules + Clarithromycin placebo tablets, twice daily (BID) for 14 days Receives: Drug: Rifasutenizol capsules; Drug: Rabeprazole sodium enteric-coated tablets; Drug: Amoxicillin Capsules; Drug: Clarithromycin placebo tablets; Drug: Bismuth potassium citrate placebo capsules |
| Control Group | Active comparator | Amoxicillin capsules 1 g + Clarithromycin tablets 500 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Bismuth potassium citrate capsules 240 mg + Rifasutenizol placebo capsules, BID for 14 days Receives: Drug: Rabeprazole sodium enteric-coated tablets; Drug: Amoxicillin Capsules; Drug: Clarithromycin tablets; Drug: Bismuth potassium citrate capsules; Drug: Rifasutenizol placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication Rate of H.Pylori Infection
The eradication rate of H. pylori is defined as the percentage of participants with negative results of 13C UBT.
Measured: 4 to 6 weeks after the last dose of the study drugs
Secondary outcomes (16)
Eradication Rate of Antibiotic-resistant Strains of H.Pylori
Percentage of Participants with Successful Helicobacter Pylori (H.pylori) Eradication in Participants with antibiotic-resistant Strains of H.pylori at Baseline (based on the test results of 13C UBT)
Measured: 4 to 6 weeks after the last dose of the study drugs
Safety by Assessment of the Number of Participants With Adverse Events (AEs)
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Measured: up to 4-6 weeks after the last dose of the study drugs
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Rifasutenizol (TNP-2198) on Day 1
Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma pharmacokinetic (PK) parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, and 12 hours after Rifasutenizol (TNP-2198) administration
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Rifasutenizol (TNP-2198) on Day 14
Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Maximum Observed Plasma Concentration (Cmax) of Rifasutenizol (TNP-2198) on Day 1
Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Maximum Observed Plasma Concentration (Cmax) of Rifasutenizol (TNP-2198) on Day 14
Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Half Life (t1/2) of Rifasutenizol (TNP-2198) on Day 1
Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Half Life (t1/2) of Rifasutenizol (TNP-2198) on Day 14
Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Area Under the Plasma Concentration-time Curve Within a Dosing Interval (AUC0-tau) of Rifasutenizol (TNP-2198) on Day 1
Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Area Under the Plasma Concentration-time Curve Within a Dosing Interval (AUC0-tau) of Rifasutenizol (TNP-2198) on Day 14
Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Area Under the Plasma Concentration-time Curve From the Time of Administration Extrapolated to Infinity (AUC0-∞) of Rifasutenizol (TNP-2198) on Day 1
Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Area Under the Plasma Concentration-time Curve From the Time of Administration Extrapolated to Infinity (AUC0-∞) of Rifasutenizol (TNP-2198) on Day 14
Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Volume of Distribution (Vd/F) of Rifasutenizol (TNP-2198) on Day 1
Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Volume of Distribution (Vd/F) of Rifasutenizol (TNP-2198) on Day 14
Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Clearance (CL/F) of Rifasutenizol (TNP-2198) on Day 1
Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Clearance (CL/F) of Rifasutenizol (TNP-2198) on Day 14
Plasma concentrations of Rifasutenizol (TNP-2198) were measured by a specific and validated assay. Plasma PK parameters of Rifasutenizol (TNP-2198) were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods.
Measured: Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start18 May 2023
- Primary completion24 Dec 2023
- Study completion26 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for H.Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- TenNor Therapeutics (Suzhou) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857163
- Sponsor's protocol ID
- TNP-2198-PO-07
- Status last verified
- Jul 2025
- First submitted
- 21 Apr 2023
- Last updated
- 17 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Song Z, Zhou L, Wang W, Lan C, Tang T, Xie J, Fan H, Wang X, Zuo X, Zhu Y, Liu C, Gu Y, Feng H, Gao X, Zhang Q, Zhang H, Chen J, Geng G, Ma Z; EVEREST-HP Study Group. Rifasutenizol-based triple therapy versus bismuth plus clarithromycin-based triple therapy for first-line treatment of Helicobacter pylori infection in China (EVEREST-HP): a phase 3, multicentre, randomised, triple-dummy, double-blind, controlled, non-inferiority trial. Lancet Infect Dis. 2026 Jan;26(1):101-110. doi: 10.1016/S1473-3099(25)00438-4. Epub 2025 Sep 10.
PubMed 40945526