Avatrombopaq In Patients With Cirrhosis (AIPAC)

April 11, 2021 updated by: Christian Snitkjær, Hvidovre University Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Avatrombopaq administration
Drug: Doptelet Pill
40 mg or 60 mg Doptelet orally 10-13 days before planned procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 3 months postprocedural
Mortality, bleedning, blood clots, readmission, reoperation
3 months postprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

April 11, 2021

First Submitted That Met QC Criteria

April 11, 2021

First Posted (Actual)

April 15, 2021

Study Record Updates

Last Update Posted (Actual)

April 15, 2021

Last Update Submitted That Met QC Criteria

April 11, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIPAC21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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