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
Public ClinicalTrials.gov record NCT01421212. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Study to Assess the Pharmacokinetics of Intravenous Nabi 5% Hepatitis B Immune Globulin Used in Combination With Lamivudine
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01421212
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 1999 (Type not available)
- Primary completion
- Feb 2002 (Actual)
- Completion
- Feb 2002 (Actual)
- Last update posted
- Jan 22, 2019
1999 – 2002
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | — |
| Jackson Memorial Hospital / University of Miami | Miami | Florida | 33136 | — |
| Rush-Presbyterian - St. Luke's Medical Center | Chicago | Illinois | 60612 | — |
| The University of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| Rochester Methodist Hospital | Rochester | Minnesota | 55905 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| New York-Presbyterian Hospital Columbia-Presbyterian Medical Center | New York | New York | 10032 | — |
| The University of North Carolina Hospitals | Chapel Hill | North Carolina | 27599 | — |
| Medical College of Virginia Commenwealth University | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01421212, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 22, 2019 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01421212 live on ClinicalTrials.gov.