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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This is a prospective, interventional, case-control study at King Faisal Specialist Hospital & Research Centre in post-renal transplant patients who are receiving Grazoprevir/Elbasvir combination. Data will be compared with matched historical controls, which will be selected according to the following matching criteria: age, time from transplant to initiation of therapy. Only patients who completed at least 48 weeks of pegylated Interferon + Ribavirin therapy in the control group and 12 weeks of therapy on the case group will be enrolled. Any patient who received at least one dose of Grazoprevir/Elbasvir combination will be included in the safety analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | This is a prospective, interventional, case-control study at King Faisal Specialist Hospital & Research Centre in post-renal transplant patients who are receiving Grazoprevir/Elbasvir combination. Data will be compared with matched historical controls, which will be selected according to the following matching criteria: age, time from transplant to initiation of therapy. Only patients who completed at least 48 weeks of pegylated Interferon + Ribavirin therapy in the control group and 12 weeks of therapy on the case group will be enrolled. Any patient who received at least one dose of Grazoprevir/Elbasvir combination will be included in the safety analysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grazoprevir/Elbasvir | Drug | Medication for treatment of patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants achieving sustained virologic response at 12 weeks after the end of all treatment (SVR12) | SVR12 was defined as HCV RNA below the lower limit of quantification (\ | 12 weeks after end of all therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with change in circulating HCV RNA during treatment and after treatment discontinuation as compared to baseline. | Hepatitis C viral load refers to the amount of hepatitis C virus in a person's blood. The results of this test (known as a viral RNA test or HCV RNA test) are usually expressed as International Units/mL (IU/mL) or RNA copies/mL. The percentage of participants with change in circulating HCV RNA during treatment and after treatment discontinuation as compared to baseline will be reported. |
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Inclusion Criteria:
In order to be eligible for participation in this trial, the subject must be:
Exclusion Criteria:
The subject must be excluded from participating in the trial if the subject:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Faisal Abaalkhail, MD | Contact | 966114424982 | 24982 | abaalkhail@kfshrc.edu.sa |
| Name | Affiliation | Role |
|---|---|---|
| Faisal Abaalkhail, Md | King Faisal Specialist Hospital & Research Centre, Riyadh | Study Chair |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C000611265 | elbasvir-grazoprevir drug combination |
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| 12 weeks during therapy |
| Percentage of participants with a decrease, no change, or increase between baseline and post treatment week 12 in kidney function as measured by Estimated Glomerular Filtration Rate and Albumin Creatinine Ratio (ACR) | Any worsening of a preexisting condition related to kidney function that was associated with the use of Elbasvir/Grazoprevir. The Percentage of participants with a decrease, no change, or increase between baseline and post treatment week 12 in kidney function as measured by Estimated Glomerular Filtration Rate and Albumin Creatinine Ratio (ACR) will be reported. | 12 weeks during therapy |
| Percentage of participants experiencing acute kidney transplant rejection compared to historical control. | Any worsening of a preexisting condition related to kidney transplant rejection that was associated with the use of Elbasvir/Grazoprevir. The percentage of participants experiencing acute kidney transplant rejection compared to historical control will be reported. | 12 weeks during therapy |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |