Status:
UNKNOWN
Sustained Off-treatment Response After HBeAg Loss in Chronic Hepatitis B Patients Treated With Nucleos(t)Ide Analogues
Lead Sponsor:
University Health Network, Toronto
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a prospective randomized, open-label, phase IV clinical trial to learn the effects, good and/or bad, of discontinuing or continuing nucleos(t)ide analogue (NA) treatment for 72 weeks in partic...
Detailed Description
Chronic infection with the hepatitis B virus (HBV) is prevalent world-wide (estimated to affect 360 million individuals). Chronic hepatitis b may result in progressive liver disease that leads to cir...
Eligibility Criteria
Inclusion
- Chronic hepatitis B (HBsAg positive \> 6 months)
- Currently on NA monotherapy and for ≥1 year prior to screening
- HBeAg negative with anti-HBe antibodies and HBV DNA undetectable at least once at 12 or more months prior to screening and at screening (HBV DNA assay should have lower limit of quantification of at least 50 IU/mL)
- Documented HBeAg positive before start of NA monotherapy
- Age \> 18 years
- Written informed consent
Exclusion
- Treatment with any investigational drug within 30 days of screening
- Severe hepatitis activity as documented by ALT \>10x ULN
- Creatinine clearance \<70 ml/min
- Presence of cirrhosis as documented by biopsy within 5 years, fibroscan \>9kPa, or fibrotest \>0.48
- Pre-existent neutropenia (neutrophils ≤1,000/mm3)
- Co-infection with hepatitis C virus and/or human immunodeficiency virus (HIV)
- Other acquired or inherited causes of liver disease
- Alpha fetoprotein \>50 ng/ml
- Hyper- or hypothyroidism
- Immune suppressive treatment within the previous 6 months
- Pregnancy, lactation
- Other significant medical illnesses that might interfere with this study
- Any medical condition requiring, or likely to require chronic systemic administration of steroids, during the course of the study
- Substance abuse (alcohol (≥80 g/day)and inhaled drugs (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 :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2016
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01911156
Start Date
July 1 2013
End Date
March 1 2016
Last Update
May 28 2015
Active Locations (2)
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1
University Health Network
Toronto, Ontario, Canada, M5T 2S8
2
University Health Network
Toronto, Ontario, Canada, M5T 2S8