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Clinical trialNCT01421212CompletedPhase 1/PHASE2Interventional

Pilot Study to Assess the Pharmacokinetics of Intravenous Nabi 5% Hepatitis B Immune Globulin (Boca HBVIg) Used in Combination With Lamivudine for Patients With Hepatitis B Virus (HBV) Associated Liver Disease Undergoing Liver Transplantation

SponsorBiotest Pharmaceuticals CorporationEnrollment30Hepatitis B Virus Associated Liver Disease
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this study is to find the best monthly dose schedule for the new Hepatitis Immune Globulin (Boca HBVIg, a study drug) when used in combination with an antiviral agent Lamivudine after liver transplantation. Boca HBVIg will be given along with Lamivudine to prevent hepatitis B reinfection following liver transplantation in patients with end stage liver failure due to hepatitis B infection.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

11 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of California, San Francisco

    San Francisco, California, United States

  • University of Florida

    Gainesville, Florida, United States

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, United States

  • Jackson Memorial Hospital / University of Miami

    Miami, Florida, United States

  • Rush-Presbyterian - St. Luke'S Medical Center

    Chicago, Illinois, United States

  • the University of Michigan Health System

    Ann Arbor, Michigan, United States

  • Rochester Methodist Hospital

    Rochester, Minnesota, United States

  • Mount Sinai Medical Center

    New York, New York, United States

  • New York-Presbyterian Hospital Columbia-Presbyterian Medical Center

    New York, New York, United States

  • the University of North Carolina Hospitals

    Chapel Hill, North Carolina, United States

  • Medical College of Virginia Commenwealth University

    Richmond, Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Hepatitis B immune globulin
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Nov 1999
Primary completion
28 Feb 2002
Completion
28 Feb 2002
Last update posted
22 Jan 2019
Registered enrollment
30
Registry id
NCT01421212
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.