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Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection
Phase 3 trial testing Rifasutenizol capsules in H.Pylori Infection in 700 participants. Completed in 26 March 2024.
| Lead sponsor | TenNor Therapeutics (Suzhou) Limited |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 700 |
| Start date | 18 May 2023 |
| Primary completion | 24 December 2023 |
| Estimated completion | 26 March 2024 |
| Sites | 1 location across China |
TenNor Therapeutics (Suzhou) Limited — full company profile →
Adults 18 to 65, any sex, with H.Pylori Infection. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The eradication rate of H. pylori is defined as the percentage of participants with negative results of 13C UBT.
| Group | Value | 95% CI |
|---|---|---|
| Test Group | 323 | |
| Control Group | 304 |
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)
| Group | Value | 95% CI |
|---|---|---|
| Test Group | 92 | |
| Control Group | 105 |
| Group | Value | 95% CI |
|---|---|---|
| Test Group | 169 | |
| Control Group | 154 |
| Group | Value | 95% CI |
|---|---|---|
| Test Group | 168 | |
| Control Group | 182 |
| Group | Value | 95% CI |
|---|---|---|
| Test Group | 92 | |
| Control Group | 77 |
| Group | Value | 95% CI |
|---|---|---|
| Test Group | 19 | |
| Control Group | 24 |
| Group | Value | 95% CI |
|---|---|---|
| Test Group | 242 | |
| Control Group | 235 |
| Group | Value | 95% CI |
|---|---|---|
| Test Group | 93 | |
| Control Group | 85 |
| Group | Value | 95% CI |
|---|---|---|
| Test Group | 167 | |
| Control Group | 174 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Test Group | 131 | |
| Control Group | 184 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Test Group | 4.08 | 1.00 – 5.08 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Test Group | 4.58 | 1.00 – 5.08 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Test Group | 324 | ± 145 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Test Group | 504 | ± 187 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Test Group | 3.25 | 2.21 – 5.25 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Test Group | 3.05 | 2.45 – 5.80 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Test Group | 1160 | ± 507 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Test Group | 1950 | ± 737 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Test Group | 1240 | ± 548 |
Time frame: up to 4-6 weeks after the last dose of the study drugs. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Test Group | Control Group |
|---|---|---|---|
| Vertigo positional | Ear and labyrinth disorders | — | — |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | — | — |
| Sclerosing pneumocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Haematochezia | Gastrointestinal disorders | — | — |
| Defaecation disorder | Gastrointestinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Reaction | System | Test Group | Control Group |
|---|---|---|---|
| Dysgeusia | Nervous system disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
Most-reported serious reactions: Vertigo positional, Intervertebral disc protrusion, Sclerosing pneumocytoma, Haematochezia, Defaecation disorder, Abdominal pain.
Data from ClinicalTrials.gov NCT05857163 adverse events section.
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.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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