Chronic Hepatitis B
Conditions
Keywords
Hepatitis B, sustained response, peginterferon, nucleos(t)ide analogues
Brief summary
Treatment with a nucleoside analogue and subsequent viral decline has shown to partially restore immune hyporesponsiveness in chronic hepatitis B patients. Recent pilot studies investigating whether the effect of lowering viral load with nucleoside analogue therapy prior to the initiation of peginterferon results in higher sustained off-treatment responses showed contradictory findings. The aim of this study is to investigate sustained off-treatment response to peginterferon alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide analogues, thereby lowering viral load
Interventions
DRUGNucleos(t)ide analogue treatment with a peginterferon add-on strategy
peginterferon 1.5 microgram/kg once a week Treatment with one of the approved nucleos(t)ide analogues
Treatment with one of the approved nucleos(t)ide analogues
Sponsors
Foundation for Liver Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Chronic hepatitis B (HBsAg positive \> 6 months) * HBeAg positive, anti-HBe negative within one month prior to initiation of peginterferon alfa-2b * HBV DNA \< 2000 IU/ml during nucleos(t)ide analogue treatment within one month prior to initiation of peginterferon alfa-2b * Compensated liver disease * Age \> 18 years * Written informed consent
Exclusion criteria
* Treatment with any investigational drug within 30 days of entry to this protocol * Severe hepatitis activity as documented by ALT\>10 x ULN * History of decompensated cirrhosis (defined as jaundice in the presence of cirrhosis, ascites, bleeding gastric or esophageal varices or encephalopathy) * Pre-existent neutropenia (neutrophils \<1,800/mm3) or thrombocytopenia (platelets \<90,000/mm3) * Co-infection with hepatitis C virus, hepatitis D virus or human immunodeficiency virus (HIV) * Other acquired or inherited causes of liver disease: alcoholic liver disease, obesity induced liver disease, drug related liver disease, auto-immune hepatitis, hemochromatosis, Wilson's disease or alpha-1 antitrypsin deficiency * Alpha fetoprotein \> 50 ng/ml * Hyper- or hypothyroidism (subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained response defined as HBeAg loss and HBV DNA level < 200 IU/mL | at week 72 |
Countries
Netherlands
Outcome results
None listed