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

Chronic Hepatitis B Clinical Trial

— Stop  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01911156
• Other study ID #: Stop Study
• Secondary ID: GILEAD Sciences
• Status: Recruiting
• Phase: Phase 4
• First received: June 25, 2013
• Last updated: May 27, 2015
• Start date: July 2013
• Est. completion date: March 2016

Study information

• Verified date: May 2015
• Source: University Health Network, Toronto
• Contact: Harry Janssen, MD
• Phone: 416-603-5986
• Email: harry.janssen[@]uhn.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Continue NA treatment
Prescribed NA during the 72 week study period
• Discontinue NA Treatment
Discontinue NA Treatment

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		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	Yes