Hepatitis B Clinical Trial
Official title:
Establishing Monitoring Strategies in Individuals With Prior Hepatitis B Virus Exposure Undergoing Anti-CD20 Antibody Containing Chemotherapy: A Prospective Observational Study
NCT number | NCT03155984 |
Other study ID # | UW15-384 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2013 |
Est. completion date | December 1, 2017 |
Verified date | May 2018 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Hepatitis B virus (HBV) reactivation is common during anti-CD20 containing chemotherapy, even in HBsAg-negative patients with only prior HBV exposure. The optimal timing of commencing antiviral therapy and the interval of clinical monitoring is uncertain. 25% of the Hong Kong population has prior HBV exposure. The investigators plan monitor this cohort of patients and determine (1) the optimal time point for starting antiviral therapy based on the progression of HBV reactivation, and (2) the optimal interval of clinical monitoring.
Status | Completed |
Enrollment | 83 |
Est. completion date | December 1, 2017 |
Est. primary completion date | June 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age =18 years. 2. Eastern Cooperative Oncology Group (ECOG) performance score of =2. 3. HBsAg-negative, anti-HBc positive patient receiving anti-CD20 containing chemotherapy with or without antibody to the hepatitis B surface antigen (anti-HBs). 4. Baseline normal serum alanine amiontransferase (ALT) (=30 U/L for men, =19 U/L for women). Exclusion Criteria: 1. Concomitant liver diseases including chronic hepatitis C and D infection, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis and primary sclerosing cholangitis. 2. Significant alcohol intake (>30 grams per day). 3. History of prior anti-HBV therapy, hematopoietic stem-cell transplantation, anti-CD20 antibody therapy, anti-CD52 antibody therapy or anti-tumour necrosis factor antibody therapy. 4. Baseline detectable HBV DNA (=10 IU/mL). These patients will be started on prophylactic entecavir. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HBV Reactivation | HBV DNA >= 10 IU/mL | From commencement of anti-CD20 antibody therapy for up to 2 years | |
Secondary | HBV-related hepatitis | ALT >60 U/L for men; >38 U/L for women; and HBV DNA >2,000 IU/mL | From commencement of anti-CD20 antibody therapy for up to 2 years |
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