Recruiting

Nucleos(t)ide Analogue

Sponsor:

University Health Network, Toronto

Code:

NCT01911156

Conditions

Chronic Hepatitis B

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Continue NA treatment

Discontinue NA Treatment

Study Details

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 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

Chronic Hepatitis B

Study ID

NCT01911156

Start date

Jul, 2013

Status verified date

May, 2015

Completion date

Mar, 2016

Anticipated

Primary completion date

Jan, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Discontinue NA treatment

Subjects will not receive NA during the 72 week study period

other: NA treatment

Subjects will continue to receive their prescribed NA during the 72 week study period

Interventions

Continue NA treatment

Prescribed NA during the 72 week study period

Discontinue NA Treatment

Discontinue NA Treatment

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Harry Janssen, MD

416-603-5986harry.janssen@uhn.ca

Victor Lo, MASc, CCRP

416-603-5839victor.lo@uhn.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Victor Lo, MASc, CCRP

416-603-5839victor.lo@uhn.ca

Principal Investigator:

Harry Janssen, MD

University Health Network

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Victor Lo

416-603-5839victor.lo@uhn.ca

Ambreen Arif

Ambreen.Arif@uhnresearch.ca

Principal Investigator:

Harry Janssen, Prof.

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 28, 2015

Last verified

May, 2015

Keywords

  • Chronic Hepatitis B

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2015-05-28.