Hepatitis CNCT02528461
Macrophage Activation Markers During Sofosbuvir-based Treatment Regimes of Chronic Hepatitis C
An observational study of Hepatitis C, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of the study is to investigate how the liver is affected with regard to inflammation and fibrosis during Sofosbuvir based treatment regimes of chronic hepatitis C. In order to examine how the liver heals, we want to use blood samples to check for the occurrence of special liver inflammation cells (CD163… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Galactose, Gastroscopy and Liver biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 71 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2015to Jan 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic hepatitis C initiating sofosbuvir-based direct-acting antiviral treatment.
Who may be able to join
- Hepatitis C and initiation of sofosbuvir-based direct-acting antiviral treatment
Who cannot join
- HIV or Hepatitis B Virus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring Inflammation Cells (CD163 and CD206) With the Purpose of Examining Reduction of Fibrosis in the Liver of Chronic Hepatitis C Patients Following Treatment With the Medication Sofosbuvir
The purpose of the study is to investigate how the liver is affected with regard to inflammation and fibrosis during Sofosbuvir based treatment regimes of chronic hepatitis C.
In order to examine how the liver heals, we want to use blood samples to check for the occurrence of special liver inflammation cells (CD163 and CD206). To assess to which extent fibrosis disappear during treatment, we want to examine the liver with FibroScan (a type of ultrasound examination) and also preferably with extraction of a small tissue sample. We want to examine how the liver function as inflammation and scar tissue decrease, especially concerning the liver's ability to produce proteins. Furthermore, we want to examine with a gastroscopy, if the circulation of blood in the liver is improved after successful treatment with the expected result that potential varicose veins in the esophagus vanish.
- Conditions
- Hepatitis C
- Being tested
- Galactose, Gastroscopy, Liver biopsy, Fibroscan, Liver vein catheterization
- Keywords
- Sofosbuvir, Direct acting anti-viral treatment, liver cirrhosis
- Medical subject headings
- Hepatitis C, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GalactoseDrug
Also called GEC
A test to investigate the liver's ability to metabolize galactose to glucose by injecting galactose followed by measurements of blood glucose and the quantification of galactose in the urine.
GastroscopyProcedure or surgery
Liver biopsyProcedure or surgery
FibroscanProcedure or surgery
Liver vein catheterizationProcedure or surgery
SofosbuvirDrug
| Study group | Role | What they receive |
|---|---|---|
| Sofosbuvir | All patients receiving Sofosbuvir based treatment regimes during the study period will be included in the study.
All patients will receive all interventions (galactose elimination capacity test, gastroscopy, fibroscan), except liver biopsy which the patients may decline to participate in without affecting the participation in the rest of the study. If varices are found during the gastroscopy a liver vein catheterization will be performed. Receives: Drug: Galactose; Procedure: Gastroscopy; Procedure: Liver biopsy; Procedure: Fibroscan; Procedure: Liver vein catheterization; Drug: Sofosbuvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the macrophage activation markers sCD163 and sCD206
Measured: 1 year
Secondary outcomes (5)
Changes in liver fibrosis with fibroscan
Liver fibrosis will be determined using fibroscan, and reported as changes in the amount of fibrosis in the liver
Measured: 1 year
Changes in histological liver fibrosis
Liver fibrosis will be also be determined on liver biopsies. Determining changes in fibrosis from baseline to after treatment.
Measured: 1 year
Changes in clinical status
Defined by the number of patients with the occurrence of cirrhosis complications, eg. ascites, hepatic encephalopathy, variceal bleeding.
Measured: 1 year
Changes in hepatic venous pressure
Hepatic venous pressure will be assessed with liver vein catheterization before and after treatment and the results reported as changes between baseline and after treatment.
Measured: 1 year
Changes in metabolic liver function determined by the galactose elimination capacity (GEC) test
GEC will be applied before and after treatment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2019
- Study completionJan 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Henning Grønbæk, Professor, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528461
- Sponsor's protocol ID
- HCV sCD163 Sofosbuvir
- Status last verified
- Sep 2019
- First submitted
- 14 Aug 2015
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Inflammation Cells (CD163 and CD206) With the Purpose of Examining Reduction of Fibrosis in the Liver of Chronic Hepatitis C Patients Following Treatment With the Medication Sofosbuvir
- ClinicalTrials.gov ID
- NCT02528461
- Acronym / sponsor ID
- HCV sCD163 Sofosbuvir
- Conditions
- Hepatitis C
- Keywords
- Sofosbuvir, Direct acting anti-viral treatment, liver cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 19 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.
The purpose of the study is to investigate how the liver is affected with regard to inflammation and fibrosis during Sofosbuvir based treatment regimes of chronic hepatitis C.
In order to examine how the liver heals, we want to use blood samples to check for the occurrence of special liver inflammation cells (CD163 and CD206). To assess to which extent fibrosis disappear during treatment, we want to examine the liver with FibroScan (a type of ultrasound examination) and also preferably with extraction of a small tissue sample. We want to examine how the liver function as inflammation and scar tissue decrease, especially concerning the liver's ability to produce proteins. Furthermore, we want to examine with a gastroscopy, if the circulation of blood in the liver is improved after successful treatment with the expected result that potential varicose veins in the esophagus vanish.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sofosbuvir | – | Drug: Galactose, Procedure: Gastroscopy, Procedure: Liver biopsy, Procedure: Fibroscan, Procedure: Liver vein catheterization, Drug: SofosbuvirAll patients receiving Sofosbuvir based treatment regimes during the study period will be included in the study. All patients will receive all interventions (galactose elimination capacity test, gastroscopy, fibroscan), except liver biopsy which the patients may decline to participate in without affecting the participation in the rest of the study. If varices are found during the gastroscopy a liver vein catheterization will be performed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic hepatitis C initiating sofosbuvir-based direct-acting antiviral treatment.
Key inclusion criteria (1 listed)
- Hepatitis C and initiation of sofosbuvir-based direct-acting antiviral treatment
Key exclusion criteria (1 listed)
- HIV or Hepatitis B Virus
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 |
|---|---|---|
| GalactoseAlso: GECA test to investigate the liver's ability to metabolize galactose to glucose by injecting galactose followed by measurements of blood glucose and the quantification of galactose in the urine. | Drug | Sofosbuvir |
| Gastroscopy | Procedure or surgery | Sofosbuvir |
| Liver biopsy | Procedure or surgery | Sofosbuvir |
| Fibroscan | Procedure or surgery | Sofosbuvir |
| Liver vein catheterization | Procedure or surgery | Sofosbuvir |
| Sofosbuvir | Drug | Sofosbuvir |
Primary outcome
Changes in the macrophage activation markers sCD163 and sCD206
Time frame: 1 year
5 secondary outcomes
Changes in liver fibrosis with fibroscan
Time frame: 1 year
Changes in histological liver fibrosis
Time frame: 1 year
Changes in clinical status
Time frame: 1 year
Changes in hepatic venous pressure
Time frame: 1 year
Changes in metabolic liver function determined by the galactose elimination capacity (GEC) test
Time frame: 1 year
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 7 Apr 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 1 inclusion and 1 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 7 Apr 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?
Changes in the macrophage activation markers sCD163 and sCD206 (time frame: 1 year). 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 7 Apr 2020.