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This phase Ⅰb/Ⅱa, single-center, randomized, open-label study was designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary Helicobacter Pylori eradication efficacy in asymptomatic subjects with Helicobacter Pylori infection after multiple doses of TNP-2198 capsules combined with rabeprazole sodium enteric-coated tablets, or TNP-2198 capsules combined with rabeprazole sodium enteric-coated tablets and amoxicillin capsules.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | TNP2198 capsules 200 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID |
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| Group B | Experimental | TNP2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID |
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| Group C | Experimental | TNP2198 capsules 600 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID |
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| Group D | Experimental | TNP2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID + amoxicillin capsules 1g BID |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNP-2198 | Drug | On Days 1 to 14, all subjects in each group received TNP-2198 capsule within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast. |
| Measure | Description | Time Frame |
|---|---|---|
| The Eradication Rate of Helicobacter Pylori Infection | Eradication rate of H. pylori is defined as negative urea breath test result. | Urea breath test is assessed 4-6 weeks after the treatment (Day 44~ Day 50) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| TenNor Clinical Trials | TenNor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Changchun | Jilin | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38359854 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | TNP-2198 capsules 200 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID On Days 1 to 14, all subjects received TNP-2198 capsules(200mg) and rabeprazole sodium enteric-coated tablets (20 mg) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 20, 2021 |
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| Rabeprazole Sodium | Drug | On Days 1 to 14, all subjects in each group received rabeprazole within 30 minutes before breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes before breakfast. |
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| Amoxicillin | Drug | On Days 1 to 14, all subjects in each group received Amoxicillin capsule within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast. |
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| FG001 | Group B | TNP-2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID On Days 1 to 14, all subjects received TNP-2198 capsules(400mg) and rabeprazole sodium enteric-coated tablets (20 mg) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast. |
| FG002 | Group C | TNP-2198 capsules 600 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID On Days 1 to 14, all subjects received TNP-2198 capsules(600 mg) and rabeprazole sodium enteric-coated tablets (20 mg) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast. |
| FG003 | Group D | TNP-2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID + amoxicillin capsules 1g BID On Days 1 to 14, all subjects received TNP-2198 capsules(400mg), rabeprazole sodium enteric-coated tablets(20mg) and Amoxicillin capsules(1g) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | TNP-2198 capsules 200 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID On Days 1 to 14, all subjects received TNP-2198 capsules(200mg) and rabeprazole sodium enteric-coated tablets (20 mg) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast. |
| BG001 | Group B | TNP-2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID On Days 1 to 14, all subjects received TNP-2198 capsules(400mg) and rabeprazole sodium enteric-coated tablets (20 mg) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast. |
| BG002 | Group C | TNP-2198 capsules 600 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID On Days 1 to 14, all subjects received TNP-2198 capsules(600 mg) and rabeprazole sodium enteric-coated tablets (20 mg) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast. |
| BG003 | Group D | TNP-2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID + amoxicillin capsules 1g BID On Days 1 to 14, all subjects received TNP-2198 capsules(400mg), rabeprazole sodium enteric-coated tablets(20mg) and Amoxicillin capsules(1g) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Eradication Rate of Helicobacter Pylori Infection | Eradication rate of H. pylori is defined as negative urea breath test result. | Posted | Count of Participants | Participants | Urea breath test is assessed 4-6 weeks after the treatment (Day 44~ Day 50) |
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Day 1 to Day 17
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A | TNP-2198 capsules 200 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID On Days 1 to 14, all subjects received TNP-2198 capsules(200mg) and rabeprazole sodium enteric-coated tablets (20 mg) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast. | 0 | 10 | 0 | 10 | 6 | 10 |
| EG001 | Group B | TNP-2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID On Days 1 to 14, all subjects received TNP-2198 capsules(400mg) and rabeprazole sodium enteric-coated tablets (20 mg) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast. | 0 | 10 | 0 | 10 | 8 | 10 |
| EG002 | Group C | TNP-2198 capsules 600 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID On Days 1 to 14, all subjects received TNP-2198 capsules(600 mg) and rabeprazole sodium enteric-coated tablets (20 mg) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast. | 0 | 10 | 0 | 10 | 5 | 10 |
| EG003 | Group D | TNP-2198 capsules 400 mg BID + rabeprazole sodium enteric-coated tablets 20 mg BID + amoxicillin capsules 1g BID On Days 1 to 14, all subjects received TNP-2198 capsules(400mg), rabeprazole sodium enteric-coated tablets(20mg) and Amoxicillin capsules(1g) within 30 minutes after breakfast and dinner (BID) for 14 consecutive days. On Day 15, the subjects were only administered once within 30 minutes after breakfast. | 0 | 10 | 0 | 10 | 8 | 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood Creatinine Increased | Investigations | MedDRA 24.1 | Systematic Assessment |
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| Alanine aminotransferase(AST)increased | Investigations | MedDRA 24.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 24.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| TenNor Medical Information | TenNor Therapeutics (Suzhou) Limited. | 0512-86861979 | info@tennorx.com |
| Nov 2, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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