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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02526641 |
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Date of registration:
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13/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Macrophages, Portal Hypertension, and Liver Function During AbbVie Treatment of Chronic Hepatitis C
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Scientific title:
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New AbbVie Direct Acting Antiviral (DAA) Treatment of Chronic Hepatitis C Infection - Effects on the Macrophage Activation Marker Soluble CD163, Portal Hypertension, and Metabolic Liver Function |
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Date of first enrolment:
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August 2015 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02526641 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Henning Grønbæk, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Aarhus University Hospital |
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Key inclusion & exclusion 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
Age minimum:
30 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hepatitis C
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Intervention(s)
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Procedure: Functional Hepatic Nitrogen Clearance (FHNC)
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Procedure: Liver vein catheterization
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Procedure: Galactose Elimination Capacity (GEC)
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Primary Outcome(s)
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Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 12 weeks
[Time Frame: 12 weeks]
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Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 1 year
[Time Frame: 1 year]
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Secondary Outcome(s)
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Changes in the levels of the macrophage specific activation marker sCD163
[Time Frame: Before, during and after treatment - 60 weeks]
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Changes in metabolic liver function determined by the galactose elimination capacity (GEC) test
[Time Frame: After 12 weeks treatment]
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Changes in the functional hepatic nitrogen clearance (FHNC)
[Time Frame: After 12 weeks treatment]
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Secondary ID(s)
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HCV sCD163 AbbVie
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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