|
Main
|
|
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. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02528461 |
|
Date of registration:
|
14/08/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Macrophage Activation Markers During Sofosbuvir-based Treatment Regimes of Chronic Hepatitis C
|
|
Scientific 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 |
|
Date of first enrolment:
|
January 2015 |
|
Target sample size:
|
71 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02528461 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Denmark
| | | | | | | |
|
Contacts
|
|
Name:
|
Henning Grønbæk, Professor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Aarhus University Hospital |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Hepatitis C and initiation of sofosbuvir-based direct-acting antiviral treatment
Exclusion Criteria:
- HIV or Hepatitis B Virus
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Hepatitis C
|
|
Intervention(s)
|
|
Procedure: Gastroscopy
|
|
Procedure: Fibroscan
|
|
Procedure: Liver vein catheterization
|
|
Drug: Galactose
|
|
Drug: Sofosbuvir
|
|
Procedure: Liver biopsy
|
|
Primary Outcome(s)
|
|
Changes in the macrophage activation markers sCD163 and sCD206
[Time Frame: 1 year]
|
|
Secondary Outcome(s)
|
|
Changes in hepatic venous pressure
[Time Frame: 1 year]
|
|
Changes in liver fibrosis with fibroscan
[Time Frame: 1 year]
|
|
Changes in histological liver fibrosis
[Time Frame: 1 year]
|
|
Changes in metabolic liver function determined by the galactose elimination capacity (GEC) test
[Time Frame: 1 year]
|
|
Changes in clinical status
[Time Frame: 1 year]
|
|
Secondary ID(s)
|
|
HCV sCD163 Sofosbuvir
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|