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| Name | Class |
|---|---|
| American College of Gastroenterology | OTHER |
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The main goal of this study is to prevent liver allograft infection with Hepatitis C virus in hepatitis C positive patients undergoing liver transplantation. The hypothesis is that patients who receive ribavirin immediately before transplant and intravenous interferon alfa 2b during the anhepatic phase(while the liver is removed)will have sustained virologic response post liver transplant.
The study is evaluating intravenous interferon given during the anhepatic phase of lvier transplant. Ribavirin was given as well. Serial measurements for HCV RNA were determined 12, 24 72, 96 hrs and 4 weeks after liver transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV interferon | Experimental | IV interferon oral ribavirin |
|
| Standard of care | No Intervention | standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV interferon | Drug | IV interferon 5MU during anhepatic phase |
|
| Measure | Description | Time Frame |
|---|---|---|
| HCV RNA Result | Will measure mean HCV RNA levels 4 weeks after liver transplant | 4 weeks after liver transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark W Russo, MD, MPH | Wake Forest University Health Sciences | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | IV Interferon | IV interferon oral ribavirin IV interferon: IV interferon 5MU during anhepatic phase |
| FG001 | no Treatment | standard of care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IV Interferon | IV interferon oral ribavirin Aims The purpose of this study was to determine the safety and effect of intravenous interferon (IFN) during the anhepatic phase of LT on hepatitis C viral load. Methods Fifteen consecutive subjects undergoing liver transplant for hepatitis C cirrhosis were enrolled in the study, ten of which received study drug and five subjects served as controls. Cases received weight-based ribavirin and subcutaneous IFN at time of incision followed by intravenous IFN at the start of the anhepatic phase. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | HCV RNA Result | Will measure mean HCV RNA levels 4 weeks after liver transplant | Posted | Mean | Standard Deviation | IU/ml | 4 weeks after liver transplant |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IV Interferon | IV interferon oral ribavirin IV interferon: IV interferon 5MU during anhepatic phase |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flash pulmonary edema | Cardiac disorders | Systematic Assessment | Flash pulmonary edema occurred during liver transplant surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pulmonary edema | General disorders | Systematic Assessment | pulmonary edema |
small sample size short duration of treatment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark W. Russo | Carolinas Medical Center | 704-355-6649 | mark.russo@carolinashealthcare.org |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D007372 | Interferons |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| BG001 | no Treatment | standard of care for liver transplant |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
standard of care for liver transplant
|
|
| 3 |
| 10 |
| 1 |
| 10 |
| EG001 | no Treatment | standard of care for liver transplant | 0 | 5 | 0 | 5 |
|
| Acute cellular rejection | Immune system disorders | Systematic Assessment | Liver biopsy showed acute cellular rejection 1 week post transplant. The treating physician 's assessment is the acute rejection was most likely due to a low prograf level. |
|
| Increased leukopenia requiring administration of granulocyte colony stimulating factor | Blood and lymphatic system disorders | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011506 | Proteins |
| D001685 | Biological Factors |