NCT04845659

Avatrombopaq In Patients With Cirrhosis

Treatment With Avatrombopaq in Patients With Cirrhosis Undergoing Small Invasive Procedure: A Prospective Case Series

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hvidovre University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thrombocytopenia; Drugs
• Cirrhosis, Liver
• Procedural Bleeding

Interventions

Type	Name	Description
DRUG	Doptelet Pill	40 mg or 60 mg Doptelet orally 10-13 days before planned procedure.

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2021-04-15
• Last updated: 2021-04-15