Helicobacter Pylori InfectionPhase 2NCT06076694

Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants

A Phase 2 study testing TNP-2198, Rabeprazole Sodium and Amoxicillin in people with Helicobacter Pylori Infection, run by TenNor Therapeutics (Suzhou) Limited at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a single-center, randomized, open-label phase Ic/IIb clinical study to evaluate the efficacy and safety of TNP-2198 capsules, rabeprazole sodium enteric-coated tablets and amoxicillin capsules combined with multiple doses of rabeprazole sodium enteric-coated tablets and amoxicillin capsules compared with… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Helicobacter Pylori Infection
What is being tested?: TNP-2198, Rabeprazole Sodium and Amoxicillin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteChina
Study dates: 26 Jun 2022to 20 Sep 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Signing the informed consent form (ICF);
Male and female subjects aged 18 to 65 years (inclusive);
Health condition: no clinically significant history of heart, liver, kidney, digestive tract, nervous system, respiratory system diseases, mental disorders or metabolic abnormalities;
Normal results or clinically insignificant abnormal results in physical examinations and vital signs;
Positive result of 14C urea breath test (UBT);
The subject (including the partner) is willing to take effective contraceptive measures voluntarily without pregnancy plan in the next 6 months;
Willing to follow and able to complete all trial procedures.

Who cannot join

History of Helicobacter Pylori eradication therapy (including participation in other clinical studies of Helicobacter Pylori eradication);
Average daily consumption of more than 5 cigarettes within 3 months prior to the start of the study;
History of hypersensitivity to study drug or its excipients, or allergic constitution (allergy to multiple drugs and food);
History of drug and/or alcohol abuse (mean consumption of ≥ 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of liquor, or 100 mL of wine);
Blood donation or massive blood loss (> 450 mL) within 3 months prior to screening;
Using any drug that changes liver enzyme activity within 28 days prior to screening;

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Taking orally any prescription drug, over-the-counter drug, any vitamin product, or herbal medicine within 14 days prior to screening;
Taking special diet (including dragon fruit, mango, grapefruit, etc.) or strenuous exercise, or having other factors that affect drug absorption, distribution, metabolism, excretion, etc., within 2 weeks prior to screening;
Significant changes in diet or exercise habits recently;
Those who have participated in, or are still participating in clinical studies within 1 months before taking the study drug;
With difficulty in swallowing or history of any gastrointestinal diseases that affect drug absorption;
With any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers;
With clinically significant ECG abnormalities;
Female subjects who are lactating during the screening period or during the study, or have positive serum pregnancy test results;
With symptoms or previous history of cardiovascular, digestive, respiratory, urinary, neurological, hematologic, immunological, endocrine system diseases or tumor, or psychiatric diseases;
Clinically significant abnormalities in clinical laboratory tests, or other clinically significant findings (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, neoplastic, pulmonary, immunological, psychiatric, or cardiovascular disease);
Those who have positive tests results of viral hepatitis (including hepatitis B and C), HIV antibody, treponema pallidum antibody (additional Rapid Plasma Reagin（RPR）test is required for those with positive treponema pallidum antibody);
Acute illness occurs or concomitant medication is used from the date of signing the informed consent to the date prior to study medication;
Consumption of chocolate, any caffeine- or xanthine-containing food or drink within 48 hours prior to taking the study drug;
Consumption of any alcoholic product within 48 hours prior to taking the study drug;
Those who have positive test result of urine drug screening or history of drug abuse or drug addiction within the past 5 years;
Those who have other conditions that, in the opinion of the investigator, make participation in this study inappropriate.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Hospital of Jilin University
Changchun, Jilin

Other trials in China

About this study

Official title: Single-center, Randomized, Open-label Phase Ic/IIb Clinical Study to Evaluate the Efficacy and Safety of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules Combined With Multiple Doses of Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules Compared With Multiple Doses of Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules Combined With Multiple Doses in Helicobacter Pylori Infection-positive Population

Conditions: Helicobacter Pylori Infection
Being tested: TNP-2198, Rabeprazole Sodium, Amoxicillin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TNP-2198Drug
Also called Rifasutenizol
Group A, TNP-2198 capsules 400mg(4 capsules),BID, 14days Group B, TNP-2198 capsules 600mg(6 capsules),BID, 14days Group C , TNP-2198 capsules 600mg(6 capsules),TID, 14days Group D, TNP-2198 capsules 600mg(6 capsules),TID, 7days
Rabeprazole SodiumDrug
Group A,Group B,Control group: Rabeprazole sodium enteric-coated tablets 20 mg, BID, 14days Group C :Rabeprazole sodium enteric-coated tablets 20 mg, TID, 14 days Group D : Rabeprazole sodium enteric-coated tablets 20 mg, TID, 7 days
AmoxicillinDrug
Group A,Group B,Control group: Amoxicillin capsules 1g, BID, 14days Group D : Amoxicillin capsules 1g, TID, 7 days

Study groups in NCT06076694
Study group	Role	What they receive
Group A	Experimental	TNP-2198 capsules 400 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; Twice daily (BID) for 14 days Receives: Drug: TNP-2198; Drug: Rabeprazole Sodium; Drug: Amoxicillin
Group B	Experimental	TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; BID for 14 days Receives: Drug: TNP-2198; Drug: Rabeprazole Sodium; Drug: Amoxicillin
Group C	Experimental	TNP-2198 capsule 600 mg + rabeprazole sodium enteric-coated tablets 20 mg; Three times daily (TID) for 14 days Receives: Drug: TNP-2198; Drug: Rabeprazole Sodium
Group D	Experimental	TNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1g; TID for 7 days Receives: Drug: TNP-2198; Drug: Rabeprazole Sodium; Drug: Amoxicillin
Control group	Active comparator	Rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g Receives: Drug: Rabeprazole Sodium; Drug: Amoxicillin

What is being measured

The primary outcome is the main question the study is designed to answer.

The Eradication Rate of Helicobacter Pylori Infection
Eradication rate of H. pylori is defined as negative urea breath test result.
Measured: Group A, B,C,control group: Urea breath test is assessed Day 44~Day 50 after the first dose; Group D: Urea breath test is assessed Day 37~ Day 43 after the first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 202220 Sep 2022

First posted11 Oct 2023
Study start26 Jun 2022
Primary completion20 Sep 2022
Study completion20 Sep 2022

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 Helicobacter 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06076694
Sponsor's protocol ID: TNP-2198-06
Status last verified: Oct 2023
First submitted: 26 Sep 2023
Last updated: 12 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Li X, Liu Y, Wang M, Gao L, Liu J, Zhang H, Wu M, Chen H, Lou J, Wang J, Chen J, Geng G, Ma Z, Ding Y. Safety, pharmacokinetics, and efficacy of rifasutenizol, a novel dual-targeted antibacterial agent in healthy participants and patients in China with Helicobacter pylori infection: four randomised clinical trials. Lancet Infect Dis. 2024 Jun;24(6):650-664. doi: 10.1016/S1473-3099(24)00003-3. Epub 2024 Feb 12.
PubMed 38359854

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
Not yet recruitingPhase 2
Vonoprazan-Amoxicillin Dual Therapy for Helicobacter Pylori Infection in United States Adolescents
Helicobacter Pylori Infection
Active, not recruiting
Efficacy and Safety of Second-Line Helicobacter Pylori Eradication
HELICOBACTER PYLORI INFECTIONS

All Helicobacter Pylori Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-center, Randomized, Open-label Phase Ic/IIb Clinical Study to Evaluate the Efficacy and Safety of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules Combined With Multiple Doses of Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules Compared With Multiple Doses of Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules Combined With Multiple Doses in Helicobacter Pylori Infection-positive Population
ClinicalTrials.gov ID: NCT06076694
Acronym / sponsor ID: TNP-2198-06
Conditions: Helicobacter Pylori Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: TenNor Therapeutics (Suzhou) LimitedIndustry (pharma, biotech, devices)
Study start: 26 Jun 2022 (actual)
Primary completion: 20 Sep 2022 (actual)
Study completion: 20 Sep 2022 (actual)
First posted: 11 Oct 2023 (actual)
Results: Posted 12 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Group A	Experimental	Drug: TNP-2198, Drug: Rabeprazole Sodium, Drug: AmoxicillinTNP-2198 capsules 400 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; Twice daily (BID) for 14 days
Group B	Experimental	Drug: TNP-2198, Drug: Rabeprazole Sodium, Drug: AmoxicillinTNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g; BID for 14 days
Group C	Experimental	Drug: TNP-2198, Drug: Rabeprazole SodiumTNP-2198 capsule 600 mg + rabeprazole sodium enteric-coated tablets 20 mg; Three times daily (TID) for 14 days
Group D	Experimental	Drug: TNP-2198, Drug: Rabeprazole Sodium, Drug: AmoxicillinTNP-2198 capsules 600 mg + rabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1g; TID for 7 days
Control group	Active comparator	Drug: Rabeprazole Sodium, Drug: AmoxicillinRabeprazole sodium enteric-coated tablets 20 mg + amoxicillin capsules 1 g

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Signing the informed consent form (ICF);
Male and female subjects aged 18 to 65 years (inclusive);
Health condition: no clinically significant history of heart, liver, kidney, digestive tract, nervous system, respiratory system diseases, mental disorders or metabolic abnormalities;
Normal results or clinically insignificant abnormal results in physical examinations and vital signs;
Positive result of 14C urea breath test (UBT);

Key exclusion criteria (22 listed)

History of Helicobacter Pylori eradication therapy (including participation in other clinical studies of Helicobacter Pylori eradication);
Average daily consumption of more than 5 cigarettes within 3 months prior to the start of the study;
History of hypersensitivity to study drug or its excipients, or allergic constitution (allergy to multiple drugs and food);
History of drug and/or alcohol abuse (mean consumption of ≥ 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of liquor, or 100 mL of wine);
Blood donation or massive blood loss (> 450 mL) within 3 months prior to screening;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TNP-2198Also: RifasutenizolGroup A, TNP-2198 capsules 400mg(4 capsules),BID, 14days Group B, TNP-2198 capsules 600mg(6 capsules),BID, 14days Group C , TNP-2198 capsules 600mg(6 capsules),TID, 14days Group D, TNP-2198 capsules 600mg(6 capsules),TID, 7days	Drug	Group A, Group B, Group C, Group D
Rabeprazole SodiumGroup A,Group B,Control group: Rabeprazole sodium enteric-coated tablets 20 mg, BID, 14days Group C :Rabeprazole sodium enteric-coated tablets 20 mg, TID, 14 days Group D : Rabeprazole sodium enteric-coated tablets 20 mg, TID, 7 days	Drug	Control group, Group A, Group B, Group C, Group D
AmoxicillinGroup A,Group B,Control group: Amoxicillin capsules 1g, BID, 14days Group D : Amoxicillin capsules 1g, TID, 7 days	Drug	Control group, Group A, Group B, Group D

Primary outcome

The Eradication Rate of Helicobacter Pylori Infection
Time frame: Group A, B,C,control group: Urea breath test is assessed Day 44~Day 50 after the first dose; Group D: Urea breath test is assessed Day 37~ Day 43 after the first dose
Eradication rate of H. pylori is defined as negative urea breath test result.

Results and safety

Results posted to the registry on 12 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A	20	19
Group B	20	18
Group C	10	10
Group D	10	10
Control Group	20	20

Primary outcome: The Eradication Rate of Helicobacter Pylori Infection

Time frame: Group A, B,C,control group: Urea breath test is assessed Day 44~Day 50 after the first dose; Group D: Urea breath test is assessed Day 37~ Day 43 after the first dose. Count of participants. Unit: Participants

Measure	Group A n = 19	Group B n = 19	Group C n = 10	Group D n = 10	Control Group n = 20
Value	18	17	5	10	16

Population analysed: Modified Intent-to-Treat Analysis Set (mITT): Refers to all randomized participants who have 14C UBT performed on Day 28 to 34 after the last dose of the study.

Adverse events

Time frame: From Day 1 to Day 44 ~ Day 50 after the first dose. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A	0 of 20 (0%)	16 of 20 (80%)	0 of 20
Group B	0 of 20 (0%)	20 of 20 (100%)	0 of 20
Group C	0 of 10 (0%)	7 of 10 (70%)	0 of 10
Group D	0 of 10 (0%)	8 of 10 (80%)	0 of 10
Control Group	0 of 20 (0%)	14 of 20 (70%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38359854Li X, Liu Y, Wang M, Gao L, Liu J, Zhang H, Wu M, Chen H, Lou J, Wang J, Chen J, Geng G, Ma Z, Ding Y. Safety, pharmacokinetics, and efficacy of rifasutenizol, a novel dual-targeted antibacterial agent in healthy participants and patients in China with Helicobacter pylori infection: four randomised clinical trials. Lancet Infect Dis. 2024 Jun;24(6):650-664. doi: 10.1016/S1473-3099(24)00003-3. Epub 2024 Feb 12.
Individual participant dataSharing planned: No

Related trials for Helicobacter Pylori Infection

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Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

TenNor Clinical Trials study director

TenNor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TNP-2198, Rabeprazole Sodium and Amoxicillin in people with Helicobacter Pylori Infection, run by TenNor Therapeutics (Suzhou) Limited at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Eradication Rate of Helicobacter Pylori Infection (time frame: Group A, B,C,control group: Urea breath test is assessed Day 44~Day 50 after the first dose; Group D: Urea breath test is assessed Day 37~ Day 43 after the first dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06076694, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023; AzTrials last refreshed its copy on 7 Nov 2026.