NCT02526641

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

3.6 years

First QC Date

August 13, 2015

Last Update Submit

November 3, 2020

Conditions

Hepatitis C

Keywords

Direct acting antiviral treatmentsCD163Portal hypertensionMetabolic liver functionCirrhosis

Outcome Measures

Primary Outcomes (2)

  • Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 12 weeks

    12 weeks

  • Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 1 year

    1 year

Secondary Outcomes (3)

  • Changes in the levels of the macrophage specific activation marker sCD163

    Before, during and after treatment - 60 weeks

  • Changes in metabolic liver function determined by the galactose elimination capacity (GEC) test

    After 12 weeks treatment

  • Changes in the functional hepatic nitrogen clearance (FHNC)

    After 12 weeks treatment

Study Arms (1)

AbbVie

Procedure: Functional Hepatic Nitrogen Clearance (FHNC)Procedure: Galactose Elimination Capacity (GEC)Procedure: Liver vein catheterization

Interventions

Functional Hepatic Nitrogen Clearance (FHNC)PROCEDURE
AbbVie
Galactose Elimination Capacity (GEC)PROCEDURE
AbbVie
Liver vein catheterizationPROCEDURE
AbbVie

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic hepatitis C patients initiating direct-acting anti-viral therapy.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hepatology and Gastroenterology, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Hepatitis CHypertension, PortalFibrosis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Henning Grønbæk, Professor

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2015

First Posted

August 18, 2015

Study Start

August 1, 2015

Primary Completion

March 1, 2019

Study Completion

November 1, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Locations

DK(1)