drugset / Trial / NCT04845659

Avatrombopaq In Patients With Cirrhosis

NCT04845659

Phase 4 Unknown 20 enrolled Hvidovre University Hospital
NaSingle-groupOpen-labelPrevention

Summary

Thrombocytopenia is a frequent issue in patients with cirrhosis undergoing various types of procedures (e.g. liver biopsy, endoscopy and minor surgical interventions). Thrombocytopenia \< 50\*10\^9/L increases the risk of perioperative and postoperative bleedning and might prevent patients with cirrhosis to undergo important procedures. Doptelet is a small molecular trombopoetin agonist, which results in proliferation and differentiation of megakaryocytes in the bone marrow resulting in increased levels of thrombocytes. It is given orally as a pill and is used to increase platelet count in patients with severe thrombocytopenia (\< 50\*10\^9/L) and cirrhosis and thus not to normalize platelet count. This study investigates the safety and efficacy of Doptelet in patients with cirrhosis and thrombocytopenia (\< 50\*10\^9/L) undergoing minor procedures like Transjugular Adjusted Liver Biopsy (TJALB) and gastroscopy.

Timeline

Start
2021-06-01
Primary completion
2022-06-01
Completion
2022-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Avatrombopag Small molecule 40 mg Oral
Subject Avatrombopag Small molecule 60 mg Oral