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Efficacy and Safety of Intramuscular HBIG Grifols for the Prevention of Recurrence After Liver Transplantation

NCT00895713 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2009-05-08

No results posted yet for this study

Summary

The purpose of this study is to determine if treatment with intramuscular hepatitis B virus immune globulin Grifols, a new specific hepatitis B immune globulin, is effective and safe for the prevention of hepatitis B virus recurrence after orthotopic liver transplantation.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

intramuscular hepatitis B virus immune globulin

Biweekly intramuscular doses of 2000 IU administered during 6 consecutive months

Sponsors & Collaborators

  • Instituto Grifols, S.A.

    lead INDUSTRY

Principal Investigators

  • Franco Filipponi, Prof. MD · Liver Transplantation Co-ordinating Section. Cisanello Hospital. (University of Pisa).

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2005-06-30
Completion
2005-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00895713 on ClinicalTrials.gov