Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 75 of 440 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01911156
First received: June 25, 2013
Last updated: July 7, 2014
Last verified: July 2013
  Purpose

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 Intervention Phase
Chronic Hepatitis B
Drug: Continue NA treatment
Drug: Discontinue NA Treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

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 [ 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 66
Study Start Date: July 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic hepatitis B (HBsAg positive >6 months)
  • HBeAg negative and HBV DNA <200 IU/ml on at least 2 occasions over the last year during NA treatment
  • 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
  • History of decompensated cirrhosis
  • Co-infection with hepatitis C virus, hepatitis D virus 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01911156

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

Locations
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
Principal Investigator: Harry Janssen, Prof. University Heath Network
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01911156     History of Changes
Other Study ID Numbers: Stop Study, GILEAD Sciences Canada, Inc.
Study First Received: June 25, 2013
Last Updated: July 7, 2014
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Chronic Hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Hepatitis, Viral, Human
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014