NCT04845659

UnknownPhase 4

Avatrombopaq In Patients With Cirrhosis

Hvidovre University Hospital Source

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Other study identifiers

Sponsor study identifier

AIPAC21

Study Type

interventional

Estimated enrollment

20

Locations

0 countries

Sites

N/A

Timeline

Study Start

June 1, 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

June 1, 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 1, 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 20 participants
Study completion date: June 1, 2022
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 0 countries · 0 sites

Trial Relationships

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Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
April 11, 2021
Actual (reported)
First Posted
April 15, 2021
Actual (reported)
Study Start
June 1, 2021
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 1, 2022
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2022
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: April 15, 2021
Status Verified: April 2021
Last Update Submitted: April 11, 2021

Conditions

Thrombocytopenia; Drugs Cirrhosis, Liver Procedural Bleeding

Keywords

CirrhosisThrombocytopenia

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 PillDrug

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

Intervention

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age: \>17 years and ≤80 years
ASA I-III

Sponsors & Collaborators

Hvidovre University Hospital
Otherlead

MeSH Terms

Conditions

ThrombocytopeniaLiver CirrhosisFibrosis

Interventions

avatrombopag

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopeniaLiver DiseasesDigestive System DiseasesPathologic ProcessesPathological 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

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

June 1, 2022

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Phase 4Completed

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Phase 4Unknown

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Phase 4Recruiting

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Phase 4Completed

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)

Contact the study team to confirm eligibility.

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 1, 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

April 15, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04845659
Data provider: ClinicalTrials.gov
Source updated: 2021-04-15
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:18:07 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Intervention

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record