CompletedNot Applicable

Optimizing HBV Management During Anti-CD20 Antibodies

Hong Kong83 participantsStarted 2013-10-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥18 years.
✓. Eastern Cooperative Oncology Group (ECOG) performance score of ≤2.
✓. HBsAg-negative, anti-HBc positive patient receiving anti-CD20 containing chemotherapy with or without antibody to the hepatitis B surface antigen (anti-HBs).
✓. Baseline normal serum alanine amiontransferase (ALT) (≤30 U/L for men, ≤19 U/L for women).

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).
✕. 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.
✕. Baseline detectable HBV DNA (≥10 IU/mL). These patients will be started on prophylactic entecavir.

What they're measuring

HBV Reactivation

Timeframe: From commencement of anti-CD20 antibody therapy for up to 2 years

Trial details

NCT IDNCT03155984

SponsorThe University of Hong Kong

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-06-01

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