Hepatitis B immunoglobulin plus Lamivudine to prevent recurrent hepatitis B following liver transplantation

Hepatitis B immunoglobulin plus Lamivudine to prevent recurrent hepatitis B following liver transplantation - HBIG plus LAM to prevent HBV recurrence

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001756

Enrollment

Registered

2009-03-05

Start date

2009-02-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Liver transplant candidates with end-stage liver diseases due to hepatitis B.

Interventions

Lamivudine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients undergoing/underwent liver transplantation for hepatitis B-related end-stage liver diseases. 2)Patients who comply with periodical intra-vascular administration of HBIG. 3)HBV-DNA undetectable at 3 weeks post liver transplantation. 4)HBsAg negative at 3 weeks post liver transplantation. 5)GOT <= 2X UNL (upper normal limit) and GPT <= 2X UNL.

Exclusion criteria

Exclusion criteria: 1) HIV co-infection. 2) Lamivudine sensitivity. 3) Severe renal dysfunction (serum Cr >= 2.0 mg/dL) 4) Resistance to Lamivudine.

Design outcomes

Primary

Measure	Time frame
The rate of hepatitis B recurrence post liver-transplantation.	—

Secondary

Measure	Time frame
To compare the rate of Hepatitis B recurrence post liver-transplantation to our histolical control (HBIG alone).	—

Countries

Japan

Contacts

Public ContactNoriyo Yamashiki

University of Tokyo Organ Transplantation Service

nyamashiki-gi@umin.ac.jp03-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026