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Macrophages, Portal Hypertension, and Liver Function During AbbVie Treatment of Chronic Hepatitis C

NCT ID: NCT02526641

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2020-11-30

Brief Summary

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Investigation of the effects of the new Abbvie direct acting anti-viral (DAA) treatment of chronic viral hepatitis C infection on the macrophage specific activation marker soluble CD163, portal hypertension determined by the hepatic venous pressure gradient (HVPG), and metabolic liver function determined by the galactose elimination capacity (GEC) test and the functional hepatic nitrogen clearance (FHNC).

Detailed Description

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Conditions

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Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AbbVie

Functional Hepatic Nitrogen Clearance (FHNC)

Intervention Type PROCEDURE

Galactose Elimination Capacity (GEC)

Intervention Type PROCEDURE

Liver vein catheterization

Intervention Type PROCEDURE

Interventions

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Functional Hepatic Nitrogen Clearance (FHNC)

Intervention Type PROCEDURE

Galactose Elimination Capacity (GEC)

Intervention Type PROCEDURE

Liver vein catheterization

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Chronic hepatitis C genotype 1 or 4 patients initiating the new AbbVie treatment (paritaprevir, ritonavir, ombitasvir og dasabuvir sammen med ribavirin)
* Child-Pugh A liver cirrhosis

Exclusion Criteria

* Severe liver dysfunction - Child-Pugh klasse B-C
* Life expectancy less than 6 months
* planned liver transplantation or TIPS procedure within 6 months
* non-compliance to treatment or study procedures
* allergy to the DAA drugs used (paritaprevir, ritonavir, ombitasvir, dasabuvir, and ribavirin)
* pregnancy or expected pregnancy during the study (anti-conception has to be used)
* breast feeding
* portal vein thrombosis
* liver cancer or other malignancies
* alcohol consumption
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

AbbVie

INDUSTRY

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henning Grønbæk, Professor

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Department of Hepatology and Gastroenterology, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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HCV sCD163 AbbVie

Identifier Type: -

Identifier Source: org_study_id