Prevention of HBV reinfection after liver transplantation using entecavir monotherapy after short-term HBIg administration: A pilot studyVersion 1.2 2008-09-11Amendment 2 2009-07-07

Phase 1

• Conditions: chronic hepatitis B; MedDRA version: 9.1Level: LLTClassification code 10052552Term: Hepatitis B virus

• Registration Number: EUCTR2008-005976-28-DE
• Lead Sponsor: Hannover Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-07
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

liver transplantation for hepatitis B-induced end.stage liver disease
Absence of coinfection with HIV and HCV
Female and male patients > 18 years of age
renal function as measured by estimated creatine clearance >30ml/min
patients who received a short-term HBIG administration for 4 weeks after liver transplantation
the patient is willing ans able to provide written informed concent to participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any evidence of other causes for end-stage liver disease (e. g. autoimmune hepatitis, hepatitis C, hereditary liver disease,...); Patients that do not fulfil criteria for liver transplantation; Patients with a history or evidence of any intolerance or hypersensitivity to any of the study drugs; Patients with impaired renal function (creatine clearance <30ml/min); Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malsbsorption; Patients who are pregnant or nursing; Co-administration of tenofovir and other medical products containing tenofovir disoproxil fumarate, adefovir dipivixil, didanosine, nephrotoxic medical products; Inability to comply with study procedures; current participation in any other clinical trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified