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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 up to 5 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal 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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
1,520 Previous Clinical Trials
503,178 Total Patients Enrolled
Harry Janssen, Prof.Principal InvestigatorUniversity Heath Network
~5 spots leftby Nov 2025
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