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| ID | Type | Description | Link |
|---|---|---|---|
| 6538-04-11R0 | Other Identifier | Duke legacy protocol ID |
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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
Liver transplant subjects will be given Mycophenolate (MMF) and Tacrolimus in order to help prevent post-transplant rejection.
Recurrent HCV in the liver allograft is becoming the leading indicator for retransplantation. Studies suggest that glucocorticord-based immunosuppression regimens hasten the onset and progression of recurrent chronic HCV liver disease. Treatment of acute allograft rejection with steroid boluses is also associated with rapid HCV recurrence. The relative contribution of various calcineurin inhibitors to recurrent HCV liver disease has not been established. Previous retrospective studies, as well as prospective studies have not demonstrated a difference in recurrent HCV liver disease rates between patients receiving CsA or tacrolimus immunosuppression regimens respectively.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoral | Drug | |||
| Tacrolimus | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| compare timing & severity of recurrent chronic HCV disease Neoral versus Prograf |
| Measure | Description | Time Frame |
|---|---|---|
| compare the effectiveness of Neoral with Prograf as primary immunotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Devai Desai, MD, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8596547 | Background | Gane EJ, Portmann BC, Naoumov NV, Smith HM, Underhill JA, Donaldson PT, Maertens G, Williams R. Long-term outcome of hepatitis C infection after liver transplantation. N Engl J Med. 1996 Mar 28;334(13):815-20. doi: 10.1056/NEJM199603283341302. | |
| 12619018 | Background | Berenguer M, Prieto M, Palau A, Rayon JM, Carrasco D, Juan FS, Lopez-Labrador FX, Moreno R, Mir J, Berenguer J. Severe recurrent hepatitis C after liver retransplantation for hepatitis C virus-related graft cirrhosis. Liver Transpl. 2003 Mar;9(3):228-35. doi: 10.1053/jlts.2003.50029. |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| 12362292 | Background | McCaughan GW, Zekry A. Pathogenesis of hepatitis C virus recurrence in the liver allograft. Liver Transpl. 2002 Oct;8(10 Suppl 1):S7-S13. doi: 10.1053/jlts.2002.35856. |
| 9636568 | Background | Zervos XA, Weppler D, Fragulidis GP, Torres MB, Nery JR, Khan MF, Pinna AD, Kato T, Miller J, Reddy KR, Tzakis AG. Comparison of tacrolimus with neoral as primary immunosuppression in hepatitis C patients after liver transplantation. Transplant Proc. 1998 Jun;30(4):1405-6. doi: 10.1016/s0041-1345(98)00291-7. No abstract available. |
| 11510013 | Background | Eason JD, Loss GE, Blazek J, Nair S, Mason AL. Steroid-free liver transplantation using rabbit antithymocyte globulin induction: results of a prospective randomized trial. Liver Transpl. 2001 Aug;7(8):693-7. doi: 10.1053/jlts.2001.26353. |
| 7308988 | Background | Knodell RG, Ishak KG, Black WC, Chen TS, Craig R, Kaplowitz N, Kiernan TW, Wollman J. Formulation and application of a numerical scoring system for assessing histological activity in asymptomatic chronic active hepatitis. Hepatology. 1981 Sep-Oct;1(5):431-5. doi: 10.1002/hep.1840010511. |
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| 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 |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |