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Trial record 40 of 321 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Off Treatment Durability in Chronic Hepatitis B With Good Immune Control

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ClinicalTrials.gov Identifier: NCT02738554
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : October 26, 2016
Information provided by (Responsible Party):
Wai-Kay Seto, The University of Hong Kong

Brief Summary:
Treatment cessation in chronic hepatitis B is associated with high rates of disease relapse. However patients who achieve the seroclearance of hepatitis B surface antigen (HBsAg) (<0.05 IU/mL) show good off-treatment durability after treatment cessation. Through the quantification of HBsAg, the study aims to investigate how low should quantitative HBsAg be before once can achieve successful disease control after treatment cessation.

Condition or disease Intervention/treatment
Chronic Hepatitis B Other: Treatment cessation

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Determining the Optimal Hepatitis B Surface Antigen Level for Treatment Cessation of Nucleoside Analogue Therapy in Chronic Hepatitis B: a Prospective Study
Study Start Date : January 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Treatment cessation arm
Cessation of treatment as according to Asia-Pacific Association for the Study of the Liver Guidelines for chronic hepatitis B
Other: Treatment cessation
Cessation of nucleoside analogue therapy following Asia-Pacific Association for the Study of Liver Diseases guidelines

Primary Outcome Measures :
  1. Off-treatment durability [ Time Frame: up to 48 weeks ]
    HBV DNA <2,000 IU/mL

Secondary Outcome Measures :
  1. HBV DNA <200 IU/mL [ Time Frame: up to 48 weeks ]
  2. HBV DNA <20 IU/mL [ Time Frame: up to 48 weeks ]
  3. HBsAg seroclearance (<0.05 IU/mL) [ Time Frame: up to 48 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age ≥18 years.
  2. HBsAg-positive patients on entecavir or tenofovir therapy for at least 24 months
  3. Fulfill the Asia-Pacific Association for the Study of the Liver guidelines of NA cessation:

    • HBeAg-positive at NA commencement: HBeAg seroconversion with undetectable HBV DNA (<20 IU/mL) maintained for ≥12 months
    • HBeAg-negative: Undetectable HBV DNA (<20 IU/mL) documented on 3 separate occasions of at least 6 months apart.
  4. Normal levels of serum alanine aminotransferase (ALT) documented on two separate occasions 6 months apart.
  5. Serum HBsAg between <200 IU/mL prior to NA cessation.

Exclusion Criteria:

  1. Concomitant liver diseases including chronic hepatitis C and D infection, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis and primary sclerosing cholangitis.
  2. Significant alcohol intake (>30 grams per day).
  3. Prior history of hepatocellular carcinoma (HCC) or any radiologic suspicion of HCC.
  4. Decompensated liver disease (defined as Child's B or C cirrhosis), or presence of cirrhotic complications, including variceal disease, ascites, or history of hepatic encephalopathy.
  5. Patient previously or currently on interferon therapy.
  6. History of immunosuppressive therapy or organ transplantation.
  7. Serious medical illness or malignancy.

    1. Patient previously or currently prescribed interferon therapy.
    2. Confirmed or radiologic suspicion of HCC.
    3. Serious medical illness or malignancy. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738554

Contact: Wai-Kay Seto, MD +85222553994 wkseto@hku.hk

Hong Kong
Department of Medicine, The University of Hong Kong, Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Wai-Kay Seto, MD    +85222553994    wkseto@hku.hk   
Sub-Investigator: Kevin Liu, MRCP         
Sub-Investigator: Man-Fung Yuen, MD         
Sponsors and Collaborators
The University of Hong Kong
Principal Investigator: Wai-Kay Seto, MD The University of Hong Kong

Responsible Party: Wai-Kay Seto, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02738554     History of Changes
Other Study ID Numbers: UW 15-548
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Wai-Kay Seto, The University of Hong Kong:
treatment cessation
nucleoside analogue

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections