Biomarkers Guided Stopping NAs Treatment

August 17, 2020 updated by: Nanfang Hospital of Southern Medical University

Novel Biomarkers Guided Stopping Nucleos(t)Ide Analogues After Long-term Virologic Suppression in CHB Patients: a Randomized Control Trial

The primary objective of this study is to evaluate hepatitis B surface antigen (HBsAg) loss in subjects who stop nucles(t)ide analogues (NAs) (Stop arm) compared to subjects who continue (Continue arm) Only subjects who already are on treatment with ETV, TDF or TAF monotherapy, and have achieved sustained virologic suppression (<20 IU/mL), HBeAg negativity, normal ALT for more than 1 year (pretreatment HBeAg + pts) or 3 years (pretreatment HBeAg - pts), plus qHBsAg <200 IU/mL, and HBV RNA or HBcrAg negativity will be included in this study. One treatment arm will stop the NAs therapy while the other treatment arm will continue the NAs therapy. Participants in the Stop arm will be monitored very closely with special focus on clinical relapse. If any participant in the Stop NAs arm exceeds one or more predefined limits for such flares or relapses, NAs treatment will be reinstituted.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

195

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University
        • Contact:
    • Jilin
      • Chang chun, Jilin, China
        • Recruiting
        • No. 1 Hospital affiliated to Jilin University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China
        • Recruiting
        • Shengjing Hospital of China Medical University
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Ruijin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • 18-65 years of old, male or female
  • Chronic hepatitis B patients
  • Received continuous ETV, TDF or TAF therapy for at least 1 year prior to screening and at screening
  • For patients with Hepatitis B e Antigen (HBeAg)-positive at the beginning of NAs therapy, documented hepatitis B virus <20 IU/mL, HBeAg seroconversion and ALT normalization for at least 1 year prior to screening and at screening
  • For patients with HBeAg-negative at the beginning of NAs therapy, documented hepatitis B virus <20 IU/mL, and ALT normalization for at least 3 year prior to screening and at screening
  • <= 9 kPa on Fibroscan assessment
  • qHBsAg <200 IU/mL within 24 weeks prior to screening
  • HBV RNA or HBcrAg negativity within 24 weeks prior to screening

Key Exclusion Criteria:

  • Experience of IFN treatment within 1 year prior to screening
  • Known cirrhosis
  • History of decompensated liver disease
  • History of clinical hepatic decompensation in the judgement of the investigator
  • Evidence of hepatocellular carcinoma
  • Serological evidence of coinfection with human immunodeficiency virus (HIV), hepatitis C virus, or hepatitis D infection
  • Known hypersensitivity to TDF, its metabolites, or formulation excipients
  • History of malignant disease
  • Lactating females
  • Females wishing to became pregnant during the duration of the study
  • Subjects participating in another clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Stop Arm
Stop NAs therapy
Other: Stop NAs therapy
Stop NAs therapy
NO_INTERVENTION: Continue Arm
Continue NAs therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With HBsAg Loss at Week 72 in Both Study Arms
Time Frame: Week 72
HBsAg loss is defined as qualitative HBsAg result changing from positive at baseline (BL) to negative at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.
Week 72

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With Sustained Disease Remission at Week 72 in Both Study Arms
Time Frame: Week 72
Sustained Disease Remission is defined as HBeAg negativity, HBV DNA <2000 IU/mL and ALT normalization at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.
Week 72
Proportion of Participants With Clinical Relapse at Week 72 in Both Study Arms
Time Frame: Week 72
Clinical Relapse is defined as HBV DNA >2000 IU/mL and ALT >2 ULN at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.
Week 72
Proportion of Participants With Virologic Relapse at Week 72 in Both Study Arms
Time Frame: Week 72
Virologic Relapse is defined as HBV DNA >2000 IU/mL at two consecutive timepoints [at least 14 days apart] at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.
Week 72
Change From Baseline in Quantitative HBsAg (IU/mL) in Both Study Arms
Time Frame: Week 72
The analyses were summarized by 3 treatment subgroups: Stop NAs (NAs-Free), Restart NAs, and Continue NAs When participant randomized in the Stop NAs group restarted NAs therapy, that participant was considered part of the Restart NAs group from that point forward. For Restart NAs group, baseline is defined as the last available record on or prior to the restart date of NAs.
Week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 6, 2020

Primary Completion (ANTICIPATED)

June 30, 2023

Study Completion (ANTICIPATED)

June 30, 2023

Study Registration Dates

First Submitted

August 17, 2020

First Submitted That Met QC Criteria

August 17, 2020

First Posted (ACTUAL)

August 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 19, 2020

Last Update Submitted That Met QC Criteria

August 17, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STOP-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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