Overview
PEG-interferon Alfa-2a add-on Study in HBeAg Negative Chronic Hepatitis B Patients
Status:
Completed
Completed
Trial end date:
2019-10-28
2019-10-28
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study intends to investigate whether addition of PEG-IFN alfa-2a in HBeAg-negative chronic hepatitis B patients who are pretreated with nucleos(t)ide analogues enhances the degree of HBsAg decline.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Foundation for Liver ResearchCollaborator:
Hoffmann-La RocheTreatments:
Adefovir
Entecavir
Interferon-alpha
Peginterferon alfa-2a
Tenofovir
Criteria
Inclusion Criteria:- Chronic hepatitis B (HBsAg positive > 6 months)
- HBeAg negative within six months prior to initiation of peginterferon alfa-2a
- HBV DNA < 200 IU/ml during nucleos(t)ide analogue (except Telbivudine) treatment
within one month prior to initiation of peginterferon alfa-2a
- Compensated liver disease
- Age > 18 years
- Written informed consent
Exclusion Criteria:
- Treatment with any investigational drug within 30 days of entry to this protocol
- Current treatment with Telbivudine
- 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 <1,500/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