To study the long-term effects of interferon-α treatment for chronic hepatitis B patients infection.
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Functional cure of hepatitis B infection: loss of Hepatitis B surface Antigen
+/- seroconversion to anti-HBs positivity.
Secondary outcome
- Initial response: HBeAg loss within 12 months of the end of IFN therapy
- Sustained response: no requirement for retreatment between the time of
initial response and the end of follow-up
- Serologic response at the end of follow-up:
o HBeAg loss +/- seroconversion
- Virological response at the end of follow-up
o HBV DNA <2,000 IU/mL
o HBV DNA <20 IU/mL (complete viral suppression)
- Combined response at the end of follow-up
o HBeAg loss +/- seroconversion & HBV DNA <2,000 IU/mL
o HBeAg loss +/- seroconversion & HBV DNA <20 IU/mL
- Biochemical response at the end of follow-up
o Normal ALT
- Death
- Liver-related death
- Liver transplantation (LTx)
- Hepatocellular carcinoma (HCC)
- Liver decompensation (LD; variceal bleeding, ascites, and/or hepatic
encephalopathy)
Background summary
Several meta-analyses have described that interferon-α treatment for chronic
hepatitis B infection reduces hepatitis B-related morbidity and mortality, but
these studies have analyzed the results of studies of which the median
follow-up duration does not exceed 10 years. It is essential to obtain
additional information regarding durability of response, functional cure, and
CHB-related events occurring over 10 years after treatment, as increasing age
and longer duration of infection are important risk factors for HCC and other
HBV complications.
Study objective
To study the long-term effects of interferon-α treatment for chronic hepatitis
B patients infection.
Study design
Combination of a retrospective cohort study, with transsectional prospective
data-collection in a minority of patients. Only patients who have been
discharged from medical follow-up in the past will be invited for a single
visit to our clinic for medical history taking and blood withdrawal. Some
patients will be asked for written informed consent to draw additional blood
during this particular procedure of venepuncture.
Study burden and risks
The study parameters are already available in almost all patients who have been
treated per protocol in previous studies, or who are still being treated within
a standard of care setting. Patients will be asked to donate blood only if ALT
and/or the virologic parameters are older than 6 months. The risks for these
subjects are related to blood withdrawal, and concern possible local bruising
and low risk of local infection. There is no direct benefit for the subjects.
Dr. Molewaterplein 40
Rotterdam 3015 CE
NL
Dr. Molewaterplein 40
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
- Chronic hepatitis B infection, defined as HBsAg positivity >=6 months
- Interferon-α (conventional, or peginterferon-α) treatment between 1978 and 2014
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study for analysis of the endpoints of morbidity and mortality only:
- patients who have been diagnosed with hepatitis C (HCV), hepatitis delta (HDV) or human immunodeficiency virus (HIV) coinfection , as coinfections are associated with more severe 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 | NL56347.078.15 |