9 completed. 7 Phase 1, 3 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 7 | Completed 7 |
| Phase 2 | 3 | Completed 3 |
| Phase 3 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection Rifasutenizol capsules, Rabeprazole sodium enteric-coated tablets, Amoxicillin Capsules - H.Pylori Infection | Phase 3 | Completed | TenNor Therapeutics (Suzhou) Limited | 700 | 2023-05-18 | 2025-08-17 |
| Human Mass Balance and Biotransformation Study of [14C]TNP-2198 [14C]TNP-2198 - Helicobacter Pylori Infection | Phase 1 | Completed | TenNor Therapeutics (Suzhou) Limited | 6 | 2022-07-12 | 2023-11-18 |
| Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants TNP-2198, Rabeprazole Sodium, Amoxicillin - Helicobacter Pylori Infection | Phase 2 | Completed | TenNor Therapeutics (Suzhou) Limited | 80 | 2022-06-26 | 2023-12-12 |
| A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules TNP-2198, Rabeprazole Sodium, Amoxicillin - Helicobacter Pylori Infection | Phase 1 / Phase 2 | Completed | TenNor Therapeutics (Suzhou) Limited | 40 | 2021-09-27 | 2023-11-22 |
| A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TNP-2198 Capsules in Asymptomatic Participants With Helicobacter Pylori Infection TNP-2198, TNP-2198 Placebo - Helicobacter Pylori Infection | Phase 1 | Completed | TenNor Therapeutics (Suzhou) Limited | 48 | 2020-10-20 | 2023-10-13 |
| PK Profile and Preliminary Efficacy of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia TNP-2092 capsules, Placebo - Hyperammonemia | Phase 1 / Phase 2 | Completed | TenNor Therapeutics (Suzhou) Limited | 36 | 2020-08-27 | 2025-04-25 |
| A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of TNP-2198 Capsules After Single Oral Dose in Healthy Participants TNP-2198, TNP-2198 Placebo - Helicobacter Pylori Infection | Phase 1 | Completed | TenNor Therapeutics (Suzhou) Limited | 78 | 2019-05-09 | 2023-10-13 |
| A Phase 1 Study to Evaluate PK Profile of Multiple Oral Administrations of TNP-2092 Capsules in Healthy Subjects TNP-2092 capsules, Placebo - Helicobacter Pylori Infection | Phase 1 | Completed | TenNor Therapeutics (Suzhou) Limited | 40 | 2016-11-08 | 2025-02-27 |
| A Phase 1 Study to Evaluate PK Profile and Food Effects on PK Parameters of TNP-2092 Capsules TNP-2092 capsules, TNP-2092 placebo capsules - Hyperammonemia | Phase 1 | Completed | TenNor Therapeutics (Suzhou) Limited | 58 | 2016-06-06 | 2025-04-25 |
Hyperammonemia (2)
Amoxicillin (3) · Rabeprazole (3) · TNP-2092 (3) · Bismuth (1) · Clarithromycin (1)
China (9)
Yanhua Ding, MD (3)