Sustained Off-treatment Response After HBeAg Loss in Chronic Hepatitis B Patients Treated With Nucleos(t)Ide Analogues (Stop)

May 27, 2015 updated by: University Health Network, Toronto

Sustained Off-treatment Response After HBeAg Loss in HBeAg-Pos Chronic Hepatitis B Patients Treated With Nucleos(t)Ide Analogues

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 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Victor Lo, MASc, CCRP
  • Phone Number: 416-603-5839
  • Email: victor.lo@uhn.ca

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Discontinue NA treatment
Subjects will not receive NA during the 72 week study period
Drug: Discontinue NA Treatment
Discontinue NA Treatment
Other: NA treatment
Subjects will continue to receive their prescribed NA during the 72 week study period
Drug: Continue NA treatment
Prescribed NA during the 72 week study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sustained response, defined as the presence of an HBV DNA level <2000 IU/ml at week 48 in patients with a combined response at baseline
Time Frame: Outcome of patients in whom NA monotherapy is stopped at week 0 and of patients who continue to receive NA monotherapy up till week 72
Outcome of patients in whom NA monotherapy is stopped at week 0 and of patients who continue to receive NA monotherapy up till week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Harry Janssen, Prof., University Heath Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

June 25, 2013

First Submitted That Met QC Criteria

July 25, 2013

First Posted (Estimate)

July 30, 2013

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stop Study
  • GILEAD Sciences Canada, Inc. (Other Grant/Funding Number: GILEAD Sciences Canada, Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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