Avatrombopaq In Patients With Cirrhosis

NCT04845659 | Unknown Phase 4

• 1 other identifier: AIPAC21
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Cirrhosis; Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Mortality, bleedning, blood clots, readmission, reoperation

  3 months postprocedural

Study Arms (1)

Intervention

EXPERIMENTAL

Avatrombopaq administration

Drug: Doptelet Pill

Interventions

Doptelet Pill DRUG

40 mg or 60 mg Doptelet orally 10-13 days before planned procedure.

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: \>17 years and ≤80 years
• ASA I-III
• Patients who read, understood and signed informed consent.
• Patients with a diagnosis of cirrhosis
• Thrombocytopenia \<50\*109
• The patient is scheduled for one of the following procedures: Transjugular Adjusted Liver Biopsy (TJALB), gastroscopy or percutan paracentesis of ascites in the following month.

You may not qualify if:

• Patients who do not speak and understand Danish.
• Patients who cannot cooperate within the trial.
• Patients who did not sign an informed consent regardless of the cause.
• Active drug abuse - to the discretion of the investigator.
• Thrombocytes \>50\*10\^9
• Patients with hereditary trombolic diseases (e.g. Factor V Leiden, antithrombin deficiency, protein S and C deficiency, prothrombin G202110A mutation).
• INR \> 1,7
• Ongoing infection verified by blood culture, clinical examination, and acute phase reactants (e.g. CRP)

Sponsors & Collaborators

• Hvidovre University Hospital: lead

MeSH Terms

Conditions

Thrombocytopenia; Liver Cirrhosis; Fibrosis

Interventions

avatrombopag

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christian Snitkjær, M.B.

CONTACT

+4523670279; christian_snit@hotmail.com

Line Molzen, M.D.

CONTACT

line.molzen.02@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.B.

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: April 15, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share