Sustained Off-treatment Response After HBeAg Loss in Chronic Hepatitis B Patients Treated With Nucleos(t)Ide Analogues
NCT ID: NCT01911156
Last Updated: 2015-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
66 participants
INTERVENTIONAL
2013-07-31
2016-03-31
Brief Summary
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About 66 adult men and women will participate in this study from University Health Network which includes the Toronto Western Hospital for about 72 weeks.
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Detailed Description
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Chronic hepatitis b may result in progressive liver disease that leads to cirrhosis, end-stage liver disease and hepatocellular carcinoma (HCC). Chronic hepatitis B can also be benign and non-progressive, evolving into an inactive carrier state that rarely leads to significant liver injury or HCC. Over the last few years, several highly effective antiviral agents have been developed and approved for use in the treatment of chronic hepatitis B. Current therapy of chronic hepatitis B (CHB) aims at stopping progression to cirrhosis and hepatocellular carcinoma.
This is a prospective randomized, open-label, phase IV clinical trial to learn the effects, good and/or bad, of discontinuing or continuing NA treatment for 72 weeks in participants with chronic hepatitis B infection whose immune system is controlling the amount of virus levels in the blood for at least 12 months of NA therapy.
About 66 adult men and women will participate in this study from University Health Network which includes the Toronto Western Hospital for about 72 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Discontinue NA treatment
Subjects will not receive NA during the 72 week study period
Discontinue NA Treatment
Discontinue NA Treatment
NA treatment
Subjects will continue to receive their prescribed NA during the 72 week study period
Continue NA treatment
Prescribed NA during the 72 week study period
Interventions
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Continue NA treatment
Prescribed NA during the 72 week study period
Discontinue NA Treatment
Discontinue NA Treatment
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Harry Janssen, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Heath Network
Locations
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University Health Network
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Dongelmans EJ, Feld JJ, Boonstra A, Brakenhoff SM, Wong D, Yim C, Claassen M, Honkoop P, Hansen BE, de Man RA, Fung S, Berg T, van Bommel F, Janssen HLA, Sonneveld MJ. Early HBcrAg and Anti-HBc Levels Identify Patients at High Risk for Severe Flares After Nucleos(t)ide Analogue Cessation-A Pooled Analysis of Two Clinical Trials. Aliment Pharmacol Ther. 2025 Feb;61(3):570-578. doi: 10.1111/apt.18416. Epub 2024 Dec 3.
Liem KS, Chi H, Fung S, Wong DK, Yim C, Noureldin S, Chen J, de Man RA, Sarowar A, Feld JJ, Hansen BE, Hou J, Peng J, Janssen HLA. Early virologic relapse predicts alanine aminotransferase flares after nucleos(t)ide analogue withdrawal in patients with chronic hepatitis B. J Viral Hepat. 2022 Nov;29(11):986-993. doi: 10.1111/jvh.13742. Epub 2022 Sep 14.
Liem KS, Fung S, Wong DK, Yim C, Noureldin S, Chen J, Feld JJ, Hansen BE, Janssen HLA. Limited sustained response after stopping nucleos(t)ide analogues in patients with chronic hepatitis B: results from a randomised controlled trial (Toronto STOP study). Gut. 2019 Dec;68(12):2206-2213. doi: 10.1136/gutjnl-2019-318981. Epub 2019 Aug 28.
Other Identifiers
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GILEAD Sciences Canada, Inc.
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Stop Study
Identifier Type: -
Identifier Source: org_study_id
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