OWERING VIRAL LOAD WITH NUCLEOS(T)IDE ANALOGUES PRIOR TO PEGINTERFERON ALFA-2B TREATMENT TO INCREASE SUSTAINED RESPONSE IN HBEAG-POSITIVE CHRONIC HEPATITIS B (PEGON-STUDY)
- Conditions
- chronic hepatitis B virus infection1001965410047438
- Registration Number
- NL-OMON37588
- Lead Sponsor
- Stichting Leveronderzoek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
• 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;
•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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Sustained response defined as HBV DNA level < 200 IU/ml and HBeAg<br /><br>seroconversion at week 96</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Undetectable HBV-DNA (<20 IU/ml)<br /><br>• HBsAg loss from serum<br /><br>• HBsAg decline<br /><br>• HBeAg loss from serum<br /><br>• Combined response defined as the combined presence of HBV DNA<br /><br>level < 200 IU/mL and HBeAg seroconversion at week 72</p><br>