The aim of this study is to determine the clinical benefit of effective antiviral treatment in patients with advanced fibrosis due to chronic hepatitis C infection.
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Viral infectious disorders
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- hepatcellular carcinoma
- liver failure: Ascites/encephalopathy/jaundice/variceal bleed
- death
- new onset Diabetes Mellitus
Secondary outcome
- Biochemical results:
ALT/AST/albumin/bilirubin/creatinine/glucose/insulin/HbA1c
- Hemological results: platelet count/prothrombin time
- Virology: viral load
- Ultrasound: spleen size
- Fibroscan results: liver stiffness
Background summary
The hepatitis C virus can chronically infect the liver, often leading to liver
damage (liver fibrosis). Treatment in an early stage is preferred since
successful eradication of the virus can stop the progression to advanced liver
fibrosis, or even cirrhosis. Liver cirrhosis can be complicated by liver
failure and/or liver cancer. It is recommended that cirrhotic patients have
regular control visits in the hospital, so early treatment of complications is
possible.
Liver cirrhosis is considered to be an irreversible condition of the liver.
Even after being cured from the hepatitis C infection, cirrhotic patient are
still at risk for the complications.
Currently there is some evidence that the risk of complications decreases when
the virus is eradicated in patients with advanced liver fibrosis, however to
what extend is still uncertain.
The disadvantages of the treatment for chronic hepatitis C are well known, and
involve adverse events, long treatment duration and a limited chance of
success. In all medical treatments the advantages should outweigh the
disadvantages, and so it is of great importance to have more extensive
knowledge of the benefits of antiviral treatment in hepatic C patients with
advanced fibrosis.
Study objective
The aim of this study is to determine the clinical benefit of effective
antiviral treatment in patients with advanced fibrosis due to chronic hepatitis
C infection.
Study design
Retrospective Follow-up study.
Patients with incomplete follow-up data will be contacted in order to obtain
recent data concerning their current health status.
Study burden and risks
Patients with incomplete follow-up data will be invited to visit the outpatient
clinic of the researchcenter once. During this visit a routine check-up of
patients with advanced liver disease will be performed, consisting of a medical
history, blood tests and abdominal ultrasound. The time-investment is
approximately 1.5 hours and the participants will have a low risk of hematomas
due to venipuncture for the collection of bloodsamples.
's gravendijkwal 230
3015CE Rotterdam
NL
's gravendijkwal 230
3015CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
- history of chronic Hepatitis C
- Interferon based antiviral treatment for chronic hepatitis C between 1990 en 2003
- biopsy-proven advanced liver fibrosis (metavir score F3-F4)
Exclusion criteria
- HIV infection
- chronic hepatitis B infection
- secondary liver disease
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30917.078.10 |