← Back to Search

Nucleos(t)ide Analogues

Discontinue NA treatment for Chronic Hepatitis B (Stop Trial)

Phase 4
Waitlist Available
Led By Harry Janssen, Prof.
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

Stop Trial 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 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.

Eligible Conditions
  • Chronic Hepatitis B

Stop Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

Stop Trial Design

2Treatment groups
Experimental Treatment
Group I: NA treatmentExperimental Treatment1 Intervention
Subjects will continue to receive their prescribed NA during the 72 week study period
Group II: Discontinue NA treatmentExperimental Treatment1 Intervention
Subjects will not receive NA during the 72 week study period

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,472 Previous Clinical Trials
484,927 Total Patients Enrolled
Harry Janssen, Prof.Principal InvestigatorUniversity Heath Network

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Sustained Off-treatment Response After HBeAg Loss in Chronic Hepatitis B Patients Treated With Nucleos(t)Ide Analogues
2013. "Sustained Off-treatment Response After HBeAg Loss in Chronic Hepatitis B Patients Treated With Nucleos(t)Ide Analogues". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01911156.
All > Autoimmune Hepatitis > Hepatitis B
~6 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top