Overview

Using Entecavir to Reduce Hepatitis in Highly Viremic HBV Patients During Anti-tuberculous Treatment

Status:
Unknown status
Trial end date:
2014-06-01
Target enrollment:
0
Participant gender:
All
Summary
Hepatitis during anti-tuberculous treatment (HATT) has been an obstacle in managing TB patients, especially in those with viral hepatitis. A previous study revealed the risk of HATT is significantly higher in TB patients with high serum hepatitis B virus (HBV) DNA level than those with low HBV DNA level. Based on these findings, we thus hypothesize that the risk of HATT in TB patients with high baseline serum HBV DNA level can be reduced by concomitant use of anti-HBV agent. In this proposal, we will conduct a prospective randomized clinical study to assess the reduction of HATT risk by using entecavir in TB patients with high baseline serum HBV DNA level, and to evaluate the risk of other treatment-related adverse events in two hospitals.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Taiwan University Hospital
Treatments:
Entecavir
Criteria
Inclusion Criteria:

- culture-confirmed tuberculosis

- serology-confirmed chronic HBV infection without flare-up at present (IgM
Anti-HBc-negative and either HBsAg-positive or Anti-HBc-positive)

- high serum HBV viral load, defined as >20,000 and >2,000 IU/mL for HBeAg positive and
HBeAg negative patients, respectively

- serum AST and/or ALT level <2 times ULN

- serum level of total bilirubin <2.0 mg/dL

- willing to receive directly observed therapy, short course (DOTs)

Exclusion Criteria:

- Target Disease Exceptions: human immunodeficiency virus (HIV), hepatitis C virus (HCV)
or hepatitis D virus (HDV) co-infection, multidrug-resistant tuberculosis (defined as
simultaneous resistant to isoniazid and rifampin)

- Medical History and Concurrent Diseases

1. . ever receiving anti-viral therapy for HBV

2. . alcoholism or presence of hepatic disease other than hepatitis B

3. . life expectancy less than 1 year

- Sex and Reproductive Status

1. . Pregnancy

2. . Breast-feeding