Prevention of Hepatitis B Virus Reinfection After Liver Transplantation With Entecavir

HepNet Study House, German Liverfoundation

Status and phase: Completed; Phase 3

Conditions: Liver Transplantation; Hepatitis B; Liver Disease

Treatments: Drug: Entecavir

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01046799

2008-005976-28

Details and patient eligibility

About

The purpose of this study is to determine whether hepatitis B immunoglobin can be discontinued early after hepatitis B virus (HBV) induced liver transplantation and be replaced by the nucleoside analogue entecavir to prevent hepatitis B reinfection.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• liver transplantation for hepatitis B induced endstage liver disease
• absence of coinfection with HIV and HCV
• female and male patients >= 18 years of age

Exclusion criteria

• any evidence of other causes for endstage liver disease
• patients that do not fulfill the criteria for liver transplantation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Entecavir

Experimental group

Treatment:

Drug: Entecavir