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NCT01421212 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Hepatitis B Virus Associated Liver Disease, sponsored by Biotest Pharmaceuticals Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 11
- Study locations
NCT01421212: Completed Phase 1 study of Hepatitis B Virus Associated Liver Disease, sponsored by Biotest Pharmaceuticals Corporation.
NCT01421212 is a Phase 1 study of Hepatitis B Virus Associated Liver Disease that has completed, run by Biotest Pharmaceuticals Corporation. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01421212, a Phase 1 study of Hepatitis B Virus Associated Liver Disease, has completed, sponsored by Biotest Pharmaceuticals Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 11
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL Hepatitis B Immune Globulin (Boca HBVIg)
Study Locations (11)
Florida
- University of Florida - Gainesville
- Mayo Clinic Jacksonville - Jacksonville
- Jackson Memorial Hospital / University of Miami - Miami
New York
- Mount Sinai Medical Center - New York
- New York-Presbyterian Hospital Columbia-Presbyterian Medical Center - New York
California
- University of California, San Francisco - San Francisco
Illinois
- Rush-Presbyterian - St. Luke's Medical Center - Chicago
Michigan
- The University of Michigan Health System - Ann Arbor
Minnesota
- Rochester Methodist Hospital - Rochester
North Carolina
- The University of North Carolina Hospitals - Chapel Hill
Virginia
- Medical College of Virginia Commenwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 1999-11 |
| Est. Completion | 2002-02 |
| Phase | Phase 1 |
What the finished NCT01421212 record still lists
NCT01421212 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Hepatitis B Virus Associated Liver Disease appearing as the primary indexed condition, and to 1 intervention - of which Hepatitis B Immune Globulin (Boca HBVIg) is the first listed.
NCT01421212 lists 11 locations in 8 states (Florida, New York, California).
Frequently Asked Questions
What is clinical trial NCT01421212 about?
NCT01421212 is a clinical study titled "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". 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 reinfect...
What is the current status of trial NCT01421212?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 1999-11. Estimated completion is 2002-02.
What conditions does trial NCT01421212 study?
This clinical trial studies the following conditions: Hepatitis B Virus Associated Liver Disease.
What interventions are being tested in trial NCT01421212?
The interventions under investigation include: Hepatitis B Immune Globulin (Boca HBVIg) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01421212?
This trial is sponsored by Biotest Pharmaceuticals Corporation, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01421212 being conducted?
This trial has 11 study locations across California, Florida, Illinois, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01421212's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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