The long-term follow-up interferon-a treatment for chronic hepatitis B infection

The long-term follow-up interferon-a treatment for chronic hepatitis B infection - ELITE-B study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43380

Enrollment

Registered

2016-04-01

Start date

2016-08-11

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis B infection

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Chronic hepatitis B infection, defined as HBsAg positivity >=6 months - Interferon-a (conventional, or peginterferon-a) treatment between 1978 and 2014

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
Functional cure of hepatitis B infection: loss of Hepatitis B surface Antigen +/- seroconversion to anti-HBs positivity.	—

Secondary

Measure	Time frame
- 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	—

Countries

Netherlands

Outcome results