Status:
COMPLETED
PEG-IFN in HBV Patients With Incomplete Response to NA
Lead Sponsor:
Foundation for Liver Research
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 t...
Eligibility Criteria
Inclusion
- 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
- 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/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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00883844
Start Date
April 1 2009
End Date
August 1 2012
Last Update
April 19 2013
Active Locations (2)
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1
AMC
Amsterdam, Netherlands
2
Erasmus MC, University Medical Center Rotterdam
Rotterdam, Netherlands