NCT03405597

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
97

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

11 months

First QC Date

January 4, 2018

Last Update Submit

January 12, 2018

Conditions

Chronic Hepatitis B, HBsAg, Hepatitis B Vaccine

Outcome Measures

Primary Outcomes (1)

  • HBsAb level at 4 weeks after complete vaccine injection

    HBsAb level more than 10 mIU/ml at 7 months

    an average of 7 months

Secondary Outcomes (3)

  • HBsAb level at 6 months after complete vaccine injection

    an average of 1 year

  • Adverse event from HBV vaccine

    an average of 1 year

  • Factors associated with HBV vaccine response

    an average of 1 year

Study Arms (3)

Healthy control

EXPERIMENTAL

Commercial Hepatitis B vaccine

Drug: Commercial Hepatitis B vaccine

Chronic hepatitis B with vaccination

EXPERIMENTAL

Commercial Hepatitis B vaccine

Drug: Commercial Hepatitis B vaccineOther: Standard Treatment

Chronic hepatitis B without vaccination

ACTIVE COMPARATOR

Standard treatment

Other: Standard Treatment

Interventions

Commercial Hepatitis B vaccineDRUG

Commercial Hepatitis B vaccine (Engerix B) 20 microgram subcutaneous injection at month 0, 1, 6

Also known as: Engerix B
Chronic hepatitis B with vaccinationHealthy control
Standard TreatmentOTHER

HBsAg, HBsAb test Ultrasound upper abdomen every 6 months

Chronic hepatitis B with vaccinationChronic hepatitis B without vaccination

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic Hepatitis B infection group
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

Related Publications (1)

  • Taheri H, Hasanjani Roushan MR, Soleimani Amiri MJ, Pouralijan M, Bijani A. Efficacy of Hepatitis B vaccine in those who lost Hepatitis B surface antigen during follow-up: Efficacy of HBV vaccine in those who lost HBsAg. Hepat Mon. 2011 Feb;11(2):119-22.

    PMID: 22087128BACKGROUND

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis B

Interventions

Engerix-B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tawesak Tanwandee

    Department of Medicine, Faculty of medicine Siriraj Hospital, Mahidol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suppawat Jiraphairot

CONTACT

+66 877116517suppawat_tu@hotmail.com

Tawesak Tanwandee

CONTACT

+66 24197281tawesak@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2018

First Posted

January 23, 2018

Study Start

March 30, 2017

Primary Completion

February 28, 2018

Study Completion

June 30, 2018

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

TH(1)