Comparisons of the durability of 6 months versus 12 months antiviral therapy for hepatitis B after end of chemotherapy

A prospective single-center, open-level, randomized study to compare the effectiveness of extended 6 versus 12 months tenofovir or entecavir therapy between HBV patients with cancer after completion of immunosuppressive anticancer therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17868223

Enrollment

Registered

2021-10-13

Start date

2013-01-01

Completion date

Unknown

Last updated

2022-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B in patients with cancer after completion of immunosuppressive anticancer therapy Infections and Infestations

Interventions

This was a randomized, open-label study in NA-naïve HBeAg-positive and HBeAg-negative patients with CHB. Patients received Tenofovir 300mg or Entecavir 0.5mg one week before chemothera

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Over 20 years old 2. Hepatitis B surface antigen (HBsAg) seropositive for >6 months 3. Cancer patients receiving chemotherapy

Exclusion criteria

Exclusion criteria: Patients who had co-infection with human immunodeficiency virus, hepatitis C virus or hepatitis D virus by serological assays

Design outcomes

Primary

Measure	Time frame
Virological relapse and clinical relapse rate measured using patient records at baseline, 3, 6, 9 and 12 months after cessation of antiviral therapy	—

Secondary

Measure	Time frame
1. Presence of HBsAg, HBeAg and Anti-HBe determined by commercial assays (Abbott, North Chicago, IL., USA) at baseline, 3, 6, 9 and 12 months after cessation of antiviral therapy, and then after every 6 months 2. Serum HBV DNA levels were assessed using COBAS AmpliPrep-COBAS Taqman HBV test (Roche Molecular System, Inc., Branchburg, NJ, USA), with a lower detection limit of 20IU/ml at baseline, 3, 6, 9 and 12 months after cessation of antiviral therapy, and then after every 6 months	—

Measure

Time frame

1. Presence of HBsAg, HBeAg and Anti-HBe determined by commercial assays (Abbott, North Chicago, IL., USA) at baseline, 3, 6, 9 and 12 months after cessation of antiviral therapy, and then after every 6 months 2. Serum HBV DNA levels were assessed using COBAS AmpliPrep-COBAS Taqman HBV test (Roche Molecular System, Inc., Branchburg, NJ, USA), with a lower detection limit of 20IU/ml at baseline, 3, 6, 9 and 12 months after cessation of antiviral therapy, and then after every 6 months

—

Countries

Taiwan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026