NCT02528461

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 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

January 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

April 7, 2020

Status Verified

September 1, 2019

Enrollment Period

4 years

First QC Date

August 14, 2015

Last Update Submit

April 6, 2020

Conditions

Hepatitis C

Keywords

SofosbuvirDirect acting anti-viral treatmentliver cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Changes in the macrophage activation markers sCD163 and sCD206

    1 year

Secondary Outcomes (5)

  • Changes in liver fibrosis with fibroscan

    1 year

  • Changes in histological liver fibrosis

    1 year

  • Changes in clinical status

    1 year

  • Changes in hepatic venous pressure

    1 year

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

    1 year

Study Arms (1)

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.

Drug: GalactoseProcedure: GastroscopyProcedure: Liver biopsyProcedure: FibroscanProcedure: Liver vein catheterizationDrug: Sofosbuvir

Interventions

GalactoseDRUG

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.

Also known as: GEC
Sofosbuvir
GastroscopyPROCEDURE
Sofosbuvir
Liver biopsyPROCEDURE
Sofosbuvir
FibroscanPROCEDURE
Sofosbuvir
Liver vein catheterizationPROCEDURE
Sofosbuvir
SofosbuvirDRUG
Sofosbuvir

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with chronic hepatitis C initiating sofosbuvir-based direct-acting antiviral treatment.

You may qualify if:

  • Hepatitis C and initiation of sofosbuvir-based direct-acting antiviral treatment

You may not qualify if:

  • HIV or Hepatitis B Virus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Hepatitis CLiver Cirrhosis

Interventions

GalactoseGastroscopySofosbuvir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesEndoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresUridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

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 14, 2015

First Posted

August 19, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2019

Study Completion

January 1, 2020

Last Updated

April 7, 2020

Record last verified: 2019-09

Locations

DK(1)