Risk of Hepatitis B Reactivation After Bone Marrow Transplantation With Prior Hepatitis B Virus (HBV) Exposure

Exposure to Hepatitis B Virus Clinical Trial

Official title:

Risk of Hepatitis B Reactivation After Hematopoietic Stem Cell Transplantation in Donors and Recipients With Prior HBV Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01481649
• Other study ID #: HKCTR-1422
• Secondary ID: HKCTR-1422
• Status: Completed
• Phase: N/A
• First received: November 24, 2011
• Last updated: April 13, 2016
• Start date: November 2011
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether preemptive nucleoside analogue therapy or regular virologic monitoring is the preferred method in management patients with prior exposure to hepatitis B vius (HBV) and undergoing hematopoietic stem cell transplantation (HSCT).

Description:

Occult hepatitis B virus (HBV) reactivation has been documented in bone marrow transplantation recipients who are hepatitis B surface antigen (HBsAg)-negative but with serologic evidence of prior exposure to HBV. However detailed prospective studies documenting the incidence of reactivation and the virologic and serologic kinetics of reactivation are lacking. The investigators prospective study proposes to follow-up 50 such bone marrow transplant recipients with all serologic and virologic parameters monitored every 4 weeks. Patients with detectable HBV DNA will be started on nucleoside analogue therapy. The optimal method and duration of monitoring will also be determined from our study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: February 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documented HBsAg-negative HSCT recipient with or without antibody to the hepatitis B surface antigen (anti-HBs).

• Documented anti-HBc (total)-positive.

Exclusion Criteria:

• Concomitant liver diseases including chronic hepatitis C and D infection, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis and primary sclerosing cholangitis.

• Significant alcohol intake (>30 grams per day)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Exposure to Hepatitis B Virus
• Hepatitis
• Hepatitis A
• Hepatitis B

Locations

Country	Name	City	State
Hong Kong	Department of Medicine, The University of Hong Kong, Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBV reactivation (defined as detectable HBV DNA >20 IU/mL)	From date of hematopoietic stem cell transplantation (HSCT) to 2 years after HSCT.	2 years	No