CLINICAL TRIALS PROFILE FOR HETROMBOPAG
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Clinical Trials for Hetrombopag
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT01830660 ↗ | A Phase I Study of Hetrombopag Olamine in Healthy Adult Volunteers | Completed | Jiangsu HengRui Medicine Co., Ltd. | Phase 1 | Hetrombopag Olamine made by Jiangsu Hengrui Medicine co Ltd. has shown an effect of increasing platelet count in animal and human. This study is designed in dose escalation fashion to evaluate safety, pharmacokinetics and efficacy of Hetrombopag Olamine. |
| NCT02403440 ↗ | A Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura (ITP) Patients | Unknown status | Jiangsu HengRui Medicine Co., Ltd. | Phase 1 | The purpose of this study is to obtain information on efficacy, safety and Pharmacokinetics (PK)/Pharmacodynamics (PD) of Hetrombopag over 14 days in Chinese patients with chronic ITP. |
| NCT02409394 ↗ | Effect of a High-fat Meal on the Pharmacokinetics of Hetrombopag and Mass Balance Study in Healthy Subjects | Completed | Jiangsu HengRui Medicine Co., Ltd. | Phase 1 | This open-label, randomized, two-period, two-treatment (single doses of 7.5 mg hetrombopag fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of hetrombopag and mass balance study in 12 healthy subjects. |
| NCT02614846 ↗ | Safety and Efficacy Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura (ITP) Patients | Unknown status | Jiangsu HengRui Medicine Co., Ltd. | Phase 1 | This study evaluates the safety and efficacy of 6 weeks dosing Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura Patients. All of the subjects in this study receive Hetrombopag. |
| NCT03222843 ↗ | Multicentre, Randomised Phase III Study of the Efficacy and Safety of Hetrombopag Olamine in Idiopathic Thrombocytopenic Purpura (ITP) Patient | Unknown status | Jiangsu HengRui Medicine Co., Ltd. | Phase 3 | A multicentre, randomised, double-blind,4-stages phase III study enrolled 414 patients with chronic, previously treated ITP. Dosage could be adjusted (2.5~.75 mg/day) to maintain platelet counts 50~250×109/L |
| NCT03557099 ↗ | A Study to Evaluate the Safety and Efficacy of Hetrombopag Olamine in Severe Aplastic Anemia （SAA） Patient | Recruiting | Jiangsu HengRui Medicine Co., Ltd. | Phase 1/Phase 2 | This is a Multicentre, Open-label, single-arm, Phase II Study to Evaluate the Safety and Efficacy of Hetrombopag Olamine in Patients With Severe Aplastic Anemia. 55 adult patients with SAA will be enrolled in the study. Treatment with Hetrombopag will be started at 7.5 mg/day and uptitrated according to the platelet count. The primary objective of the study is to assess the safety and efficacy of Hetrombopag in patients with SAA. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
Clinical Trial Conditions for Hetrombopag
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Clinical Trial Sponsors for Hetrombopag
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