Chronic hepatitis B virus infection MedDRA version: 9.1 Level: LLT Classification code 10008910 Term: Chronic hepatitis B
Conditions
Interventions
Trade Name: Pegasys
Product Name: Pegasys
Pharmaceutical Form: Solution for injection
CAS Number: 76543-88-9
Other descriptive name: INTERFERON ALFA-2A
Trade Name: Baraclude
Product Name: Baraclude
P
Sponsors
Stichting Lever Onderzoek
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Chronic hepatitis B (HBsAg positive > 6 months) •HBeAg positive, anti-HBe negative at screening •ALT > 1.3 x ULN within 60 days prior to screening and during screening •Liver biopsy performed within 2 years prior to screening or during screening •Age > 18 years •Written informed consent •Adequate contraception for males and females during treatment and follow up; negative pregnancy test (for women of childbearing potential) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Antiviral therapy against HBV within the previous 6 months •Treatment with any investigational drug within 30 days of screening •Previous treatment with lamivudine or telbivudine for more than six months •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 50 ng/ml •Hyper- or hypothyroidism (subjects requiring medication to maintain TSH levels in the normal range are eligible if all other inclusion/exclusion criteria are met) •Immune suppressive treatment within the previous 6 months •Contra-indications for alpha-interferon therapy like suspected hypersensitivity to interferon or PEG-interferon or any known pre-existing medical condition that could interfere with the patient's participation in and completion of the study. •Pregnancy, lactation •Other significant medical illness that might interfere with this study: significant pulmonary dysfunction in the previous 6 months, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g. HIV positivity, auto-immune diseases, organ transplants other than cornea and hair transplant) •Any medical condition requiring, or likely to require chronic systemic administration of steroids, during the course of the study •Substance abuse, such as alcohol (?80 g/day), I.V. drugs and inhaled drugs in the past 2 years. •Any other condition which in the opinion of the principal investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To study differences in outcome between one year ETV therapy with a PEG-IFN add-on strategy and one year of ETV monotherapy on suppression of HBV DNA (HBV DNA < 60IU/mL) To study differences in outcome between one year ETV therapy with a PEG-IFN add-on strategy and one year of ETV monotherapy on serum HBsAg and HBeAg loss To study differences in outcome between one year ETV therapy with a PEG-IFN add-on strategy and one year of ETV monotherapy on the emergence of entecavir-resistant mutations To study differences in the safety and tolerability between one year ETV therapy with a PEG-IFN add-on strategy and one year of ETV monotherapy To study differences in sustained response (HBeAg loss combined with HBV DNA < 200 IU/mL at 96 weeks) 24 weeks after discontinuation of treatment between responders at 48 weeks with 24 weeks of ETV consolidation treatment) after one year ETV therapy with a PEG-IFN add-on strategy and responders after one year of ETV monotherapy ;Main Objective: To study whether a PEG-IFN add-on strategy for 24 weeks during 48 weeks of ETV therapy enhances response (HBeAg loss combined with HBV DNA < 200 IU/mL), as compared to 48 weeks of ETV monotherapy in HBeAg-positive chronic hepatitis B patients.;Primary end point(s): Primary outcome (response): The combined presence of HBV DNA level < 200 IU/mL and HBeAg loss at week 48 Secondary outcomes: •ALT normalization •Undetectable HBV DNA (< 60 IU/mL) •HBsAg and HBeAg loss from serum •The emergence of HBV polymerase mutations associated with reduced susceptibility to entecavir •Sustained response defined as the combined presence of HBV DNA level < 200 IU/mL and HBeAg loss at week 96 | — |
Countries
Netherlands
Outcome results
None listed