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

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ClinicalTrials.gov Identifier: NCT01911156
Recruitment Status : Unknown
Verified May 2015 by University Health Network, Toronto.
Recruitment status was:  Recruiting
First Posted : July 30, 2013
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.


Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Continue NA treatment Drug: Discontinue NA Treatment Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sustained Off-treatment Response After HBeAg Loss in HBeAg-Pos Chronic Hepatitis B Patients Treated With Nucleos(t)Ide Analogues
Study Start Date : July 2013
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Discontinue NA treatment
Subjects will not receive NA during the 72 week study period
Drug: Discontinue NA Treatment
Discontinue NA Treatment

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




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01911156


Contacts
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Contact: Harry Janssen, MD 416-603-5986 harry.janssen@uhn.ca
Contact: Victor Lo, MASc, CCRP 416-603-5839 victor.lo@uhn.ca

Locations
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Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Victor Lo, MASc, CCRP    416-603-5839    victor.lo@uhn.ca   
Sub-Investigator: Ambreen Arif         
Principal Investigator: Harry Janssen, MD         
Sub-Investigator: Hemant Shah, MD         
Sub-Investigator: David Wong, MD         
Sub-Investigator: Jordan Feld, MD         
Sub-Investigator: Scott Fung, MD         
University Health Network Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Victor Lo    416-603-5839    victor.lo@uhn.ca   
Contact: Ambreen Arif       Ambreen.Arif@uhnresearch.ca   
Principal Investigator: Harry Janssen, Prof.         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Harry Janssen, Prof. University Heath Network

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01911156     History of Changes
Other Study ID Numbers: Stop Study
GILEAD Sciences Canada, Inc. ( Other Grant/Funding Number: GILEAD Sciences Canada, Inc. )
First Posted: July 30, 2013    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Keywords provided by University Health Network, Toronto:
Chronic Hepatitis B
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections