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This is an exploratory study to evaluate the impact of eliminating steroid administration upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in patients transplanted for HCV cirrhosis.
A comparison will be made between two regimens which both include tacrolimus, one utilizing standard steroid administration and the second with daclizumab (MAB) avoiding steroids for both prophylactic administration and anti-rejection treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | immunosuppression |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Viral load of HCV at 12 months post transplantation | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Biopsy-proven acute rejection | 12 months | |
| Acute rejection | 12 months | |
| Patient and graft survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Physician | Astellas Pharma Europe B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prague | 140 21 | Czechia | ||||
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| Label | URL |
|---|---|
| Link to FDA Website | View source |
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| steroids, monoclonal anti-IL2R antibody | Drug | immunosuppression |
|
| 12 months |
| Incidence of adverse events | 12 months |
| Besançon |
| 25030 |
| France |
| Lyon | 69317 | France |
| Nice | 06202 | France |
| Villejuif | 94804 | France |
| Berlin | 13353 | Germany |
| Hamburg | 20251 | Germany |
| Mainz | 55131 | Germany |
| Bologna | Italy |
| Genova | 16132 | Italy |
| Modena | 41100 | Italy |
| Warsaw | 02-097 | Poland |
| Barakaldo | 48903 | Spain |
| Madrid | 28035 | Spain |
| Santiago | 15706 | Spain |
| Gothenburg | 413 45 | Sweden |
| London | SE5 9RS | United Kingdom |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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