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Trial record 38 of 345 for:    hepatitis b | Open Studies

Off Treatment Durability in Chronic Hepatitis B With Good Immune Control

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by The University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
Wai-Kay Seto, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT02738554
First received: April 8, 2016
Last updated: October 24, 2016
Last verified: October 2016
  Purpose
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 Intervention
Chronic Hepatitis B
Other: Treatment cessation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Off-treatment durability [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
    HBV DNA <2,000 IU/mL


Secondary Outcome Measures:
  • HBV DNA <200 IU/mL [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • HBV DNA <20 IU/mL [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • HBsAg seroclearance (<0.05 IU/mL) [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: January 2016
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02738554

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

Locations
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
Investigators
Principal Investigator: Wai-Kay Seto, MD The University of Hong Kong
  More Information

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 
Study First Received: April 8, 2016
Last Updated: October 24, 2016
Health Authority: Hong Kong: Department of Health
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by The University of Hong Kong:
HBV
treatment cessation
HBsAg
HBcrAg
nucleoside analogue
entecavir
tenofovir

Additional relevant MeSH terms:
Hepatitis
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

ClinicalTrials.gov processed this record on December 06, 2016