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Trial record 15 of 325 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

HBsAb Response After HBV Vaccination in Chronic Hepatitis B Patients Who Have Lost HBsAg

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ClinicalTrials.gov Identifier: NCT03405597
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Brief Summary:

Chronic HBV infection is major problem in Asian countries. Years after chronic infection, in some cases serum HBsAg level declines to unmeasurable level. Some of patients develop anti-HBsAb but there is no standard treatment to accelerate HBsAg seroconversion.

There is a study to determine efficacy and safety of HBV vaccine in who is Chronic HBV infection and lost their HBsAg without seroconversion to anti-HBsAb.


Condition or disease Intervention/treatment Phase
Chronic Hepatitis B, HBsAg, Hepatitis B Vaccine Drug: Commercial Hepatitis B vaccine Other: Standard Treatment Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HBsAb Response After HBV Vaccination in Chronic Hepatitis B Patients Who Have Lost HBsAg
Actual Study Start Date : March 30, 2017
Estimated Primary Completion Date : February 28, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Healthy control
Commercial Hepatitis B vaccine
Drug: Commercial Hepatitis B vaccine
Commercial Hepatitis B vaccine (Engerix B) 20 microgram subcutaneous injection at month 0, 1, 6
Other Name: Engerix B
Experimental: Chronic hepatitis B with vaccination
Commercial Hepatitis B vaccine
Drug: Commercial Hepatitis B vaccine
Commercial Hepatitis B vaccine (Engerix B) 20 microgram subcutaneous injection at month 0, 1, 6
Other Name: Engerix B
Other: Standard Treatment
HBsAg, HBsAb test Ultrasound upper abdomen every 6 months
Active Comparator: Chronic hepatitis B without vaccination
Standard treatment
Other: Standard Treatment
HBsAg, HBsAb test Ultrasound upper abdomen every 6 months



Primary Outcome Measures :
  1. HBsAb level at 4 weeks after complete vaccine injection [ Time Frame: an average of 7 months ]
    HBsAb level more than 10 mIU/ml at 7 months


Secondary Outcome Measures :
  1. HBsAb level at 6 months after complete vaccine injection [ Time Frame: an average of 1 year ]
    HBsAb level more than 10 mIU/ml at 6 months

  2. Adverse event from HBV vaccine [ Time Frame: an average of 1 year ]
    Any adverse event from HBV vaccine by CTCAE v4.0

  3. Factors associated with HBV vaccine response [ Time Frame: an average of 1 year ]
    Factors associated with HBV vaccine response at 12 months



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Chronic Hepatitis B infection group

  • 18-80 year-old
  • Compensated liver disease
  • Chronic HBV infection with or without NUCs treatment
  • History of HBsAg positive > 6 months
  • HBsAg negative with qualitative Elecsys (Roche) twice at least 6 months apart
  • HBsAb negative
  • HBV DNA < 20 IU/mL

Healthy group

  • Healthy person without history of HBV vaccination (HBsAg, anti-HBc and HBsAb negative)

Exclusion Criteria:

  • History of previous HBV vaccination
  • Anti-HCV and/or anti-HIV positive
  • Decompensated cirrhosis
  • History of previous malignancies
  • History or currently receive immunotherapy, cytotoxic or immunosuppressive agents
  • Patient with immunodeficiency disease
  • Creatinine > 1.5 mg/dL
  • Pregnancy or lactating woman
  • Unable to consent

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): NCT03405597


Contacts
Contact: Suppawat Jiraphairot +66 877116517 suppawat_tu@hotmail.com
Contact: Tawesak Tanwandee +66 24197281 ext 102 tawesak@gmail.com

Locations
Thailand
Faculty of Medicine Siriraj Hospital Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Contact: Chairat Shayakul         
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Tawesak Tanwandee Department of Medicine, Faculty of medicine Siriraj Hospital, Mahidol University

Publications:
Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT03405597     History of Changes
Other Study ID Numbers: 13/2560(EC1)
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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
Vaccines
Immunologic Factors
Physiological Effects of Drugs