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

University Health Network, Toronto

Status and phase: Unknown; Phase 4

Conditions: Chronic Hepatitis B

Treatments: Drug: Discontinue NA Treatment; Drug: Continue NA treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01911156

Stop Study

GILEAD Sciences Canada, Inc. (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Discontinue NA treatment

Other group

Description:

Subjects will not receive NA during the 72 week study period

Treatment:

Drug: Discontinue NA Treatment

NA treatment

Other group

Description:

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

Treatment:

Drug: Continue NA treatment