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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Chronic Liver Disease Foundation | OTHER |
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Patients with ESRD will be treated with a dose escalation of ribavirin starting from 200 mg everyday (QD) to a maximal tolerated dose. Peginterferon will then be added. Ribavirin will be dose adjusted as needed. Boceprevir will then be added. Ribavirin will be dose adjusted as needed. Patients will be monitored for eRVR and SVR. The study end-point is eRVR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ribavirin, peginterferon, boceprevir | Experimental | The efficacy and safety of HCV treatment in patients with ESRD will be assessed with a maximal tolerated dose of ribavirin, peginterferon and boceprevir. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ribavirin | Drug | Ribavirin monotherapy will be started at a dose of 100 mg daily. After each successive week the dose of ribavirin will be increased by 100 mg increments daily as long as the hemoglobin remains greater than 10 gm/dl and/or there has not been a decline in the hemoglobin by more than 2 gms/dl from the pretreatment baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who achieve eRVR at treatment week 28 | The primary end-point for evaluation will be the percentage of patients who achieve eRVR at treatment week 28. | 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of treatment | A. The ability to define the maximal tolerated dose of ribavirin. B. The ability to remain on peg-interferon alfa-2b, ribavirin and boceprevir for 24 weeks C. The percentage of patients who achieve SVR | 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mitchell L Shiffman, MD | Contact | 804-977-8920 | mitchell_shiffman@bshsi.org | |
| April G. Long, NP | Contact | 804-977-8920 | april_long@bshsi.org |
| Name | Affiliation | Role |
|---|---|---|
| Mitchell L Shiffman, MD | Liver Institute of Virginia, Bon Secours Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liver Institute of Virginia | Richmond | Virginia | 23226 | United States |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012254 | Ribavirin |
| C417083 | peginterferon alfa-2b |
| C512204 | N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Peginterferon | Drug | After the patient has remained on their maximal tolerated dose of ribavirin for 1 week peginterferon alpha-2b will be initiated at a dose of 1.0 mcg/kg/week. This dose was chosen because it is known to be equivalent in achieving SVR when compared to the 1.5 mcg/kg/dose and is associated with less bone marrow suppression. The dose of ribavirin will be adjusted as needed. |
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| Boceprevir | Drug | Boceprevir will be added after the patient is on stable doses of ribavirin and peginterferon. The dose of ribavirin will be adjusted as needed. |
|
|
| 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 |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |