Trial · NCT05857163
Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection
NCT05857163, Phase 3, Completed, TenNor Therapeutics (Suzhou) Limited; results first posted 2025-08-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection. Trials, record NCT05857163. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05857163
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection
- NCT number
- NCT05857163
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 700 participants, actual
- Lead sponsor
- TenNor Therapeutics (Suzhou) Limited
- Conditions
- H.Pylori Infection
- Interventions
Rifasutenizol capsules, Rabeprazole sodium enteric-coated tablets, Amoxicillin Capsules, Clarithromycin placebo tablets, Bismuth potassium citrate placebo capsules, Clarithromycin tablets, Bismuth potassium citrate capsules, Rifasutenizol placebo capsules
- First posted
- 2023-05-12
- Last updated
- 2025-08-17
- Results first posted
- 2025-08-17
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Eradication Rate of H.Pylori Infection | 4 to 6 weeks after the last dose of the study drugs | The eradication rate of H. pylori is defined as the percentage of participants with negative results of 13C UBT. |
| Secondary | Eradication Rate of Antibiotic-resistant Strains of H.Pylori | 4 to 6 weeks after the last dose of the study drugs | 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) |
| Secondary | Safety by Assessment of the Number of Participants With Adverse Events (AEs) | up to 4-6 weeks after the last dose of the study drugs | 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. |
| Secondary | Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Rifasutenizol (TNP-2198) on Day 1 | Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, and 12 hours after Rifasutenizol (TNP-2198) administration | 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. |
| Secondary | Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Rifasutenizol (TNP-2198) on Day 14 | Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | 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. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Rifasutenizol (TNP-2198) on Day 1 | Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | 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. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Rifasutenizol (TNP-2198) on Day 14 | Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | 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. |
| Secondary | Half Life (t1/2) of Rifasutenizol (TNP-2198) on Day 1 | Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | 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. |
| Secondary | Half Life (t1/2) of Rifasutenizol (TNP-2198) on Day 14 | Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | 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. |
| Secondary | Area Under the Plasma Concentration-time Curve Within a Dosing Interval (AUC0-tau) of Rifasutenizol (TNP-2198) on Day 1 | Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Eradication Rate of H.Pylori Infection | 4 to 6 weeks after the last dose of the study drugs | All the participants who have been randomized into groups and received at least one dose of study drugs. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Eradication Rate of Antibiotic-resistant Strains of H.Pylori | 4 to 6 weeks after the last dose of the study drugs | Participants who have been randomized into groups and received at least one dose of study drugs. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety by Assessment of the Number of Participants With Adverse Events (AEs) | up to 4-6 weeks after the last dose of the study drugs | All the participants who have been randomized into groups and received at least one dose of study drugs. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Rifasutenizol (TNP-2198) on Day 1 | Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, and 12 hours after Rifasutenizol (TNP-2198) administration | All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data. | h | MEDIAN |
| SECONDARY | Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Rifasutenizol (TNP-2198) on Day 14 | Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data. | h | MEDIAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of Rifasutenizol (TNP-2198) on Day 1 | Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data. | ng/mL | MEAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of Rifasutenizol (TNP-2198) on Day 14 | Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data. | ng/mL | MEAN |
| SECONDARY | Half Life (t1/2) of Rifasutenizol (TNP-2198) on Day 1 | Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data. | h | MEDIAN |
| SECONDARY | Half Life (t1/2) of Rifasutenizol (TNP-2198) on Day 14 | Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data. | h | MEDIAN |
| SECONDARY | Area Under the Plasma Concentration-time Curve Within a Dosing Interval (AUC0-tau) of Rifasutenizol (TNP-2198) on Day 1 | Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration | All randomized participants who have received Rifasutenizol (TNP-2198) and have at least one pharmacokinetic parameter data. | h*ng/mL | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Eradication Rate of H.Pylori Infection | Test Group | 323 | Participants | ||
| Eradication Rate of H.Pylori Infection | Control Group | 304 | Participants | ||
| Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Test Group | Clarithromycin resistant | 92 | Participants | |
| Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Control Group | Clarithromycin resistant | 105 | Participants | |
| Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Test Group | Clarithromycin susceptible | 169 | Participants | |
| Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Control Group | Clarithromycin susceptible | 154 | Participants | |
| Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Test Group | Metronidazole resistant | 168 | Participants | |
| Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Control Group | Metronidazole resistant | 182 | Participants | |
| Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Test Group | Metronidazole susceptible | 92 | Participants | |
| Eradication Rate of Antibiotic-resistant Strains of H.Pylori | Control Group | Metronidazole susceptible | 77 | Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Test Group | 353 | |
| Overall Study | STARTED | Control Group | 347 | |
| Overall Study | COMPLETED | Test Group | 337 | |
| Overall Study | COMPLETED | Control Group | 337 | |
| Overall Study | NOT COMPLETED | Test Group | 16 | |
| Overall Study | NOT COMPLETED | Control Group | 10 |
Source ClinicalTrials.gov
Adverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Test Group | 24 | 351 | |
| other | Diarrhoea | Gastrointestinal disorders | Control Group | 19 | 346 | |
| other | Nausea | Gastrointestinal disorders | Test Group | 22 | 351 | |
| other | Nausea | Gastrointestinal disorders | Control Group | 21 | 346 | |
| other | Dizziness | Nervous system disorders | Test Group | 21 | 351 | |
| other | Dizziness | Nervous system disorders | Control Group | 12 | 346 | |
| other | Dysgeusia | Nervous system disorders | Test Group | 17 | 351 | |
| other | Dysgeusia | Nervous system disorders | Control Group | 125 | 346 | |
| serious | Vertigo positional | Ear and labyrinth disorders | Test Group | 0 | 351 | |
| serious | Vertigo positional | Ear and labyrinth disorders | Control Group | 1 | 346 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Test Group | 0 | 351 |
| Total, all-cause mortality | Control Group | 0 | 346 |
| Total, other adverse events | Test Group | 65 | 351 |
| Total, other adverse events | Control Group | 143 | 346 |
| Total, serious adverse events | Test Group | 2 | 351 |
| Total, serious adverse events | Control Group | 2 | 346 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40945526 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Test Group vs Control Group: Safety by Assessment of the Number of Participants With Adverse Events (AEs) | Trial comparisons |
| Test Group vs Control Group: Eradication Rate of H.Pylori Infection | Trial comparisons |
| Test Group vs Control Group: deaths from any cause | Trial comparisons |
| Test Group vs Control Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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