Prophylactic Entecavir for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    164
  • sponsor
    Dong-Gun Lee
Updated on 26 July 2021
entecavir
hepatitis b core antibody

Summary

This study is a randomized, prospective, comparative study of the effectiveness of prophylactic entecavir treatment for HBV reactivation in past HBV infected patients (HBsAg-, HBcIgG+) with hematopoietic stem cell transplantation.

Description

This study is a randomized, prospective, comparative study of the effectiveness of prophylactic entecavir treatment for HBV reactivation in past HBV infected patients (HBsAg-, HBcIgG+) with hematopoietic stem cell transplantation.

In this study, patients are randomized into treatment group or delayed treatment group.

  • Stratified randomization (Block randomization within strata) according to the presence of HBsAb at baseline was used in this study.
    1. Experimental: Treatment group (n=82) The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation. The intervention group visit clinic every month and examined liver function test, HBsAg/Ab. HBV DNA level is examined at every 3 months.
  • oral administration of entecavir is planned to start within 7 days after hematopoietic stem cell transplantation. 2. No Intervention: delayed treatment group (n=82) The delayed treatment group visit clinic every month and examined liver function test, HBsAg/Ab. HBV DNA level is examined at every 3 months. If the patient in the delayed treatment group shows HBV reactivation (positive HBsAg or HBV DNA 10 IU/mL), entecavir treatment is started.

Details
Condition antivirals, Hematopoietic Stem Cell Transplantation, Hematopoietic Stem Cell Transplant, Stem Cell Transplant, Stem Cell Transplantation, Allo-Hematopoietic Stem Cell Transplant, Allogeneic Hematopoietic Stem Cell Transplant, Hepatitis B Virus, Hepatitis B Reactivation, antiviral drugs, antiviral drug, Antiviral Agents, antiviral, HSCT, Hepatitis B
Treatment Entecavir
Clinical Study IdentifierNCT04942886
SponsorDong-Gun Lee
Last Modified on26 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age: 19 - 70
patients receiving hematopoietic stem cell transplantation
HBV serologic test: HBsAg (-), anti-HBc IgG (+)
ECOG performence: 0-2
patients with informed consent

Exclusion Criteria

HBV DNA (+, 10 IU/mL) at the time of screening
Receiving hematopoietic stem cell transplantation from donor with HBsAg+
Combined other chronic liver disease (severe alcoholics, autoimmune hepatitis, chronic hepatitis C etc.)
HIV (+)
Previous antiviral therapy history for chronic hepatitis B
Other concomitant malignancy
combined autoimmune disease (rheumatic arthritis, SLE etc)
CTP class B, C
Decompensated complications (ascites, hepatic encephalopathy etc.)
active tuberculosis
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note