The aim of this study is to investigate the T cell immune system in relation to viral kinetics in acute HBV infection in order to obtain more insight into mechanisms of failure of viral control and development of chronic HBV infection, and to…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective: to define the immunologic and virologic signature of acute
hepatitis B patients by longitudinally studying the phenotypic and functional
characteristics of peripheral blood mononuclear cells (PBMC*s) and HBV viral
kinetics. Patients with acute HBV infection will be compared to patients with
chronic HBV infection (with high and low viral load).
Secondary outcome
Secondary objective: to investigate the mechanism of development of chronic HBV
infection by comparing patients with acute HBV infection in patients clearing
the HBV within 6 months versus patients who develop chronic HBV infection.
Background summary
The mechanism of developing chronic hepatitis B virus (HBV) infection, rather
than clearing acute infection, is not fully understood but is likely
multifactorial. The ability to control (and clear) an acute HBV infection is
thought to be related to the balance between the quantity of infected
hepatocytes and the efficiency of the T-cell response. This T cell response may
be attenuated by several factors that could be divided into self-save
mechanisms and viral escape through upregulation of different cytokines.
Development of chronic hepatitis B infection is associated with impairment of
the innate and adaptive immune responses and with narrow and weak T cell
responses. It remains a question of debate whether the impairment of T cell
responses are a cause or consequence of persistent infection.
Study objective
The aim of this study is to investigate the T cell immune system in relation to
viral kinetics in acute HBV infection in order to obtain more insight into
mechanisms of failure of viral control and development of chronic HBV
infection, and to compare our findings with data already obtained in chronic
hepatitis B patients with either high and low viral load.
Study design
Observational study with multiple interventions of blood collection (6 times
during 1 year)
Study burden and risks
The burden associated with participation is that of obtaining blood samples six
times during a period of 1 year. This will be as much as possible combined with
blood sampling for routine HBV diagnostic tests (at least 2 times). There will
be additional visits (and venipunctures) required of at most three times. The
total amount of collected blood is 575 mL (including blood collected for
routine diagnostic tests), which will be collected over six times during 1
year, with a maximum of 102 mL per time. Extra sampling will be 62 ml to 69.5
ml per time, wih a total of 379,5 ml in total.
The risk of participation is only the risk associated with the procedure of
additional venipuncture (maximum of 3 times extra), being redness of the skin,
pain or hematoma at the area of the puncture.
Meibergdreef 9
Amsterdam Zuidoost 1105 AZ
NL
Meibergdreef 9
Amsterdam Zuidoost 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients that will be included are:
- patients who present to the AMC or to the AMC outpatient clinic location GG&GD Amsterdam with an acute hepatitis B infection;
- patients formerly diagnosed (at the AMC) with an acute HBV infection (within the last 5 years) and from whom blood samples for viral diagnostics at several time points were collected.
Exclusion criteria
Unwillingness to donate blood and/or sign an informed consent
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 | NL45101.018.13 |