NCT05442632

Efficacy and Safety of Herombopag in Patients With Thrombocytopenia Before Hepatectomy

Director, Department of Liver Surgery, Fudan University Shanghai Cancer Center

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, randomized, controlled study, to evaluate the efficacy and safety of Herombopag in patients with Thrombocytopenia before hepatectomy.

Detailed description

The purpose of this study is to assess the ability of Herombopag to elevate platelet counts thereby reducing the need for platelet transfusions in patients with thrombocytopenia before hepatectomy. The clinical benefit of Herombopag will be measured by the proportion of subjects who avoid platelet transfusions, before, during and up to 7 days after undergoing an hepatectomy. In addition, bleeding events will be monitored during this time. The number of transfusions, safety events will be monitored during this time and for up to 3 months after undergoing a hepatectomy to help further evaluate clinical benefit.

Conditions

• Hepatopathy

Interventions

Type	Name	Description
DRUG	Hetrombopag	The patients received Hetrombopag 5mg orally d1-14 days, surgery will be conducted at d6-14 day
DRUG	Placebo	The patients received Placebo 5mg orally d1-14 days, surgery will be conducted at d6-14 day

Timeline

• Start date: 2022-07-25
• Primary completion: 2025-12-01
• Completion: 2025-12-30
• First posted: 2022-07-05
• Last updated: 2024-03-13

Locations

1 site across 1 country: China