Addition of Peginterferon to NA-therapy in HBeAg positive patients
- Conditions
- Chronich hepatitis B virus infectionMedDRA version: 14.0Level: LLTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2011-005607-32-NL
- Lead Sponsor
- Foundation for Liver Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 80
• Chronic hepatitis B (HBsAg positive > 6 months)
• HBeAg positive, anti-HBe negative within 4 weeks prior to initiation of peginterferon alfa-2b
• HBV DNA < 2000 IU/ml within one month prior to initiation of peginterferon alfa-2b after a minimum of 12 months nucleos(t)ide analogue treatment, except Telbivudine
• Compensated liver disease
• Age = 18 years and = 70 years
• Written informed consent
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 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Treatment with any investigational drug within 30 days of entry to this protocol
•Treatment with Telbivudine
•Severe hepatitis activity as documented by ALT>5 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 ?1,500/mm3) or thrombocytopenia (platelets ?90,000/mm3)
•Co-infection with hepatitis C 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/exclusion criteria are met)
•Immune suppressive treatment within the previous 6 months
•Contra-indications for alfa-interferon therapy like suspected hypersensitivity to interferon or Peginterferon or any known pre-existing medical condition that could interfere with the patient's participation in and completion of the study.
•Pregnancy, breast-feeding
•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 investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate sustained HBeAg response to peg-interferon alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide analogues, thereby lowering viral load;Secondary Objective: no secondary objectives;Primary end point(s): • Sustained response to therapy, defined as the combined presence of HBeAg seroconversion and HBV DNA < 200 IU/mL at week 72;Timepoint(s) of evaluation of this end point: week 72
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Undetectable HBV-DNA (<20 IU/ml) <br>•HBsAg loss from serum <br>•HBsAg decline<br>•HBeAg loss from serum <br>•Combined response defined as the combined presence of HBV DNA level < 200 IU/mL and HBeAg seroconversion at week 48<br>;Timepoint(s) of evaluation of this end point: week 48 and 72