Sustained Off-treatment Response After HBeAg Loss in Chro... | NCT01911156

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

NCT01911156

Sponsor

University Health Network, Toronto

Status

Unknown status

Last Update Posted

May 28, 2015Estimated

Enrollment

66Estimated

Phase

Phase 4

Conditions

Chronic Hepatitis B

Interventions

Continue NA treatment
Discontinue NA Treatment

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
GILEAD Sciences Canada, Inc.	Other Grant/Funding Number	GILEAD Sciences Canada, Inc.

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Jan 2016Estimated

Completion Date

Mar 2016Estimated

First Submitted Date

Jun 25, 2013

First Submission Date that Met QC Criteria

Jul 25, 2013

First Posted Date

Jul 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2015

Last Update Posted Date

May 28, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Discontinue NA treatment	Other	Subjects will not receive NA during the 72 week study period	Drug: Discontinue NA Treatment
NA treatment	Other	Subjects will continue to receive their prescribed NA during the 72 week study period	Drug: Continue NA treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Continue NA treatment	Drug	Prescribed NA during the 72 week study period	NA treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Harry Janssen, MD	Contact	416-603-5986		harry.janssen@uhn.ca
Victor Lo, MASc, CCRP	Contact	416-603-5839		victor.lo@uhn.ca

Overall Officials

Name	Affiliation	Role
Harry Janssen, Prof.	University Heath Network	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Health Network	Recruiting	Toronto	Ontario	M5T 2S8	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39624922	Derived	Dongelmans EJ, Feld JJ, Boonstra A, Brakenhoff SM, Wong D, Yim C, Claassen M, Honkoop P, Hansen BE, de Man RA, Fung S, Berg T, van Bommel F, Janssen HLA, Sonneveld MJ. Early HBcrAg and Anti-HBc Levels Identify Patients at High Risk for Severe Flares After Nucleos(t)ide Analogue Cessation-A Pooled Analysis of Two Clinical Trials. Aliment Pharmacol Ther. 2025 Feb;61(3):570-578. doi: 10.1111/apt.18416. Epub 2024 Dec 3.
36048970

ID	Term
D006509	Hepatitis B
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections