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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IGIV-HB Grifols | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specific intravenous anti-hepatitis B immunoglobulin | Drug | Monthly doses of 5000 IU administered intravenously during 6 consecutive months |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine if after 4 months of continuous monthly administration of HB-IVIG Grifols, the anti-hepatitis B antibodies contained in the product reach levels considered as protective, and to assess if these levels are kept constant during 2 more months. | At months 4, 5, and 6 |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the in vivo recovery of 6 consecutive doses of HB-IVIG Grifols and demonstrate that it remains constant for each dose. | At months 1, 2, 3, 4, 5, and 6 | |
| To determine various pharmacokinetic parameters after 6 administrations of HB-IVIG Grifols |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoni Mas, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínic de Barcelona | Barcelona | Barcelona | 08035 | Spain | ||
| Hospital Vall d'Hebron |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| At months 1, 2, 3, 4, 5, and 6 |
| To determine the incidence of recurrences during the treatment | At months 1, 2, 3, 4, 5, and 6 |
| To evaluate tolerance to the administration of HB-IVIG Grifols | At months 1, 2, 3, 4, 5, and 6 |
| To confirm the viral safety of the product supervising viral markers | At months 1, 2, 3, 4, 5, and 6 |
| Barcelona |
| Barcelona |
| 08035 |
| Spain |
| Hospital Universitario 12 de Octubre | Madrid | Madrid | 28041 | Spain |
| Hospital Virgen del Rocío | Seville | Sevilla | 41013 | Spain |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |