NCT04906083

Avatrombopag in Patients With End-stage Liver Disease and Thrombocytopenia

The Efficacy and Safety of Avatrombopag in Patients With End-stage Liver Disease and Thrombocytopenia: A Multicenter, Prospective, Randomized Controlled Trial（EAST）

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

End stage liver disease is prone to thrombocytopenia. This study is a multi-center, randomized, prospective, randomized controlled Phase IV Clinical trial to discuss the Efficacy and Safety of Avatrombopag in Patients with End-stage Liver Disease and Thrombocytopenia.

Detailed description

End stage liver disease is prone to thrombocytopenia. This study aims to discuss the Efficacy and Safety of Avatrombopag in Patients with End-stage Liver Disease and Thrombocytopenia in a multicenter, prospective, randomized controlled trial. The patients were divided into one of the groups according to if receiving avatrombopag. Avatrombopag was taken to maintain platelet count 50\~100×10\^9/L. Starting dose is recommended according to the patient's baseline platelet count level. Routine treatment was taken in the Control group and Interventional group. This trial will take about 2 to 2.5 years from the first participant signing an informed consent form (ICF) until all study-related telephone follow-ups or visits end.

Conditions

• Liver Failure
• Thrombocytopenia
• Decompensated Cirrhosis

Interventions

Type	Name	Description
DRUG	Avatrombopag	Avatrombopag: PLT：30\~50×10\^9/L patients, 40 mg/d; PLT：\<30×10\^9/L patients, 60 mg/d.
DRUG	Standard medical treatment	Standard medical treatment included transmetil, compound glycyrrhizinate, reduced glutathione and hepatocyte growth factor, et. al.

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-05-28
• Last updated: 2021-06-07

Locations

1 site across 1 country: China