Hepatitis CNCT02526641
Macrophages, Portal Hypertension, and Liver Function During AbbVie Treatment of Chronic Hepatitis C
An observational study of Hepatitis C, run by University of Aarhus at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Functional Hepatic Nitrogen Clearance (FHNC), Galactose Elimination Capacity (GEC) and Liver vein catheterization
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2015to Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic hepatitis C patients initiating direct-acting anti-viral therapy.
Who may be able to join
- 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
Who cannot join
- 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)
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- breast feeding
- portal vein thrombosis
- liver cancer or other malignancies
- alcohol consumption
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Hepatology and Gastroenterology, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: 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
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).
- Conditions
- Hepatitis C
- Being tested
- Functional Hepatic Nitrogen Clearance (FHNC), Galactose Elimination Capacity (GEC), Liver vein catheterization
- Keywords
- Direct acting antiviral treatment, sCD163, Portal hypertension, Metabolic liver function, Cirrhosis
- Medical subject headings
- Hepatitis C, Hypertension, Portal, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Hepatic Nitrogen Clearance (FHNC)Procedure or surgery
Galactose Elimination Capacity (GEC)Procedure or surgery
Liver vein catheterizationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| AbbVie | Not described Receives: Procedure: Functional Hepatic Nitrogen Clearance (FHNC); Procedure: Galactose Elimination Capacity (GEC); Procedure: Liver vein catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 12 weeks
Measured: 12 weeks
Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 1 year
Measured: 1 year
Secondary outcomes (3)
Changes in the levels of the macrophage specific activation marker sCD163
Measured: Before, during and after treatment - 60 weeks
Changes in metabolic liver function determined by the galactose elimination capacity (GEC) test
Measured: After 12 weeks treatment
Changes in the functional hepatic nitrogen clearance (FHNC)
Measured: After 12 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2019
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, AbbVie
- Responsible party
- Sponsor
- Investigators
- Henning Grønbæk, Professor, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526641
- Sponsor's protocol ID
- HCV sCD163 AbbVie
- Status last verified
- Nov 2020
- First submitted
- 13 Aug 2015
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02526641
- Acronym / sponsor ID
- HCV sCD163 AbbVie
- Conditions
- Hepatitis C
- Keywords
- Direct acting antiviral treatment, sCD163, Portal hypertension, Metabolic liver function, Cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, AbbVie
- Study start
- Aug 2015 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AbbVie | – | Procedure: Functional Hepatic Nitrogen Clearance (FHNC), Procedure: Galactose Elimination Capacity (GEC), Procedure: Liver vein catheterization |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic hepatitis C patients initiating direct-acting anti-viral therapy.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Hepatic Nitrogen Clearance (FHNC) | Procedure or surgery | AbbVie |
| Galactose Elimination Capacity (GEC) | Procedure or surgery | AbbVie |
| Liver vein catheterization | Procedure or surgery | AbbVie |
Primary outcome
Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 12 weeks
Time frame: 12 weeks
Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 1 year
Time frame: 1 year
3 secondary outcomes
Changes in the levels of the macrophage specific activation marker sCD163
Time frame: Before, during and after treatment - 60 weeks
Changes in metabolic liver function determined by the galactose elimination capacity (GEC) test
Time frame: After 12 weeks treatment
Changes in the functional hepatic nitrogen clearance (FHNC)
Time frame: After 12 weeks treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henning Grønbæk, Professor principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the hepatic venous pressure gradient determined by liver vein catheterization from baseline to 12 weeks (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.