The long-term follow-up interferon-a treatment for chronic hepatitis B infectio
Recruiting
- Conditions
- Chronic hepatitis B infection10019654
- Registration Number
- NL-OMON43380
- Lead Sponsor
- Stichting Leveronderzoek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Functional cure of hepatitis B infection: loss of Hepatitis B surface Antigen<br /><br>+/- seroconversion to anti-HBs positivity.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Initial response: HBeAg loss within 12 months of the end of IFN therapy<br /><br><br /><br>- Sustained response: no requirement for retreatment between the time of<br /><br>initial response and the end of follow-up<br /><br><br /><br>- Serologic response at the end of follow-up:<br /><br>o HBeAg loss +/- seroconversion<br /><br><br /><br>- Virological response at the end of follow-up<br /><br>o HBV DNA <2,000 IU/mL<br /><br>o HBV DNA <20 IU/mL (complete viral suppression)<br /><br><br /><br>- Combined response at the end of follow-up<br /><br>o HBeAg loss +/- seroconversion & HBV DNA <2,000 IU/mL<br /><br>o HBeAg loss +/- seroconversion & HBV DNA <20 IU/mL<br /><br><br /><br>- Biochemical response at the end of follow-up<br /><br>o Normal ALT<br /><br><br /><br>- Death<br /><br>- Liver-related death<br /><br>- Liver transplantation (LTx)<br /><br>- Hepatocellular carcinoma (HCC)<br /><br>- Liver decompensation (LD; variceal bleeding, ascites, and/or hepatic<br /><br>encephalopathy)</p><br>