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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 June 2015
• Main ID: NCT01911156
• Date of registration: 25/06/2013
• Prospective Registration: Yes
• Primary sponsor: University Health Network, Toronto
• Public title: Sustained Off-treatment Response After HBeAg Loss in Chronic Hepatitis B Patients Treated With Nucleos(t)Ide Analogues Stop
• Scientific title: Sustained Off-treatment Response After HBeAg Loss in HBeAg-Pos Chronic Hepatitis B Patients Treated With Nucleos(t)Ide Analogues
• Date of first enrolment: July 2013
• Target sample size: 66
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01911156
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Canada

Contacts

• Name: Harry Janssen, MD

• Name: Harry Janssen, Prof.
• Affiliation: University Heath Network

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Hepatitis B

Intervention(s)

Drug: Discontinue NA Treatment

Drug: Continue NA treatment

Primary Outcome(s)

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]

Secondary ID(s)

Stop Study

GILEAD Sciences Canada, Inc.

Source(s) of Monetary Support

Please refer to primary and secondary sponsors