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Avatrombopaq In Patients With Cirrhosis (AIPAC)

Primary Purpose

Thrombocytopenia; Drugs, Cirrhosis, Liver, Procedural Bleeding

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Doptelet Pill

About this trial

This is an interventional prevention trial for Thrombocytopenia; Drugs focused on measuring Cirrhosis, Thrombocytopenia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Avatrombopaq administration

Outcomes

Primary Outcome Measures

Adverse Events

Mortality, bleedning, blood clots, readmission, reoperation

Secondary Outcome Measures

Full Information

NCT ID

NCT04845659

First Posted

April 11, 2021

Last Updated

April 11, 2021

Sponsor

Hvidovre University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04845659

Brief Title

Avatrombopaq In Patients With Cirrhosis

Acronym

AIPAC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2021 (Anticipated)

Primary Completion Date

June 1, 2022 (Anticipated)

Study Completion Date

June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hvidovre University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thrombocytopenia; Drugs, Cirrhosis, Liver, Procedural Bleeding

Keywords

Cirrhosis, Thrombocytopenia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Avatrombopaq administration

Intervention Type

Drug

Intervention Name(s)

Doptelet Pill

Intervention Description

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

Primary Outcome Measure Information:

Title

Adverse Events

Description

Mortality, bleedning, blood clots, readmission, reoperation

Time Frame

3 months postprocedural

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christian Snitkjær, M.B.

Phone

+4523670279

christian_snit@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Line Molzen, M.D.

line.molzen.02@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Avatrombopaq In Patients With Cirrhosis

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