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Evaluation of Serum Levels and Pharmacokinetics of a New Hepatitis B Immune Globulin Following Liver Transplantation

NCT00838071 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2009-02-06

No results posted yet for this study

Summary

The purpose of this study is to determine whether protective anti-HB serum levels are maintained after 6 months of uninterrupted treatment with IGIV-HB Grifols, a new specific hepatitis B immune globulin, in patients having previously undergone liver transplantation.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Specific intravenous anti-hepatitis B immunoglobulin

Monthly doses of 5000 IU administered intravenously during 6 consecutive months

Sponsors & Collaborators

  • Instituto Grifols, S.A.

    lead INDUSTRY

Principal Investigators

  • Antoni Mas, MD · Hospital Clinic of Barcelona

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2004-07-31
Completion
2004-08-31

Countries

  • Spain

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 NCT00838071 on ClinicalTrials.gov