Trials / Completed
CompletedNCT00838071
Evaluation of Serum Levels and Pharmacokinetics of a New Hepatitis B Immune Globulin Following Liver Transplantation
Evaluation of Anti-Hepatitis B Antibodies Levels in Serum After the Intravenous Administration of Specific Anti-Hepatitis B Immunoglobulin (IGIV-HB Grifols) in Patients Having Previously Undergone Liver Transplantation
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Instituto Grifols, S.A. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Specific intravenous anti-hepatitis B immunoglobulin | Monthly doses of 5000 IU administered intravenously during 6 consecutive months |
Timeline
- Start date
- 2003-10-01
- Primary completion
- 2004-07-01
- Completion
- 2004-08-01
- First posted
- 2009-02-06
- Last updated
- 2009-02-06
Locations
4 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT00838071. Inclusion in this directory is not an endorsement.