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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004978-29 | EudraCT Number |
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This study is divided into 2 segments, and proposes to qualify fine needle aspiration (FNA) as a platform to evaluate the hepatic pharmacokinetics of low and high oral doses of Grazoprevir (MK-5172) in non-cirrhotic participants chronically infected with hepatitis C virus (HCV). The first segment, is a procedural pilot conducted prior to the main study, that is aimed at ensuring optimal execution of the FNA procedure. During the procedural pilot, core needle biopsy (CNB) will be performed on participants as part of their standard of care, but no study drugs will be administered, nor will any procedures other than FNA be conducted. The second segment, the main study, is designed to evaluate the feasibility of measuring Grazoprevir by FNA. During the main study, drugs will be administered, and other additional procedures will be conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main Pt. 2: 800 mg Grazoprevir + Peg-IFN/RBV | Experimental | 800 mg Grazoprevir combined with Peg-Interferon/Ribavirin treatment. |
|
| Main Pt. 2: 100 mg Grazoprevir + Peg-IFN/RBV | Experimental | 100 mg Grazoprevir combined with Peg-Interferon/Ribavirin treatment. |
|
| Main Pt.1: 800 mg Grazoprevir | Experimental | 800 mg Grazoprevir. |
|
| Procedural Pilot | Experimental | Optimization of FNA procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peg-Interferon | Drug | Polyethyleneglycolated Interferon alfa-2b at 1.5 ug/kg/week, administered subcutaneously, once a week, over the entire course of the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants from whom detectable concentrations of hepatic Grazoprevir are obtained by FNA. | Days 7-12. |
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Inclusion Criteria:
Exclusion Criteria for Main study only:
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| Liver Samples from FNA | Procedure | Tissue samples are collected at 3 separate visits, with each collection consisting of 3-4 fine needle aspiration (FNA) passes through the liver, guided by ultrasound. |
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| Liver Samples from CNB | Procedure | Tissue samples are collected at 1 of six possible visits by core needle biopsy (CNB) of the liver. |
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| Blood Samples | Procedure | Blood is collected from multiple blood draws, with the total volume for each participant not expected to exceed 500 ml. |
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| Ribavirin | Drug | Ribavirin, 600-1400 mg administered orally, twice daily, over the entire course of the study. |
|
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| 800 mg Grazoprevir | Drug | 800 mg Grazoprevir administered orally, once per day, for 7 consecutive days. |
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| 100 mg Grazoprevir | Drug | 100 mg Grazoprevir administered orally, once per day, for 7 consecutive days. |
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| Liver samples from CNB and FNA | Procedure | Tissue samples from the liver are collected by CNB as part of standard of care, and also by FNA during a single visit. |
|
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
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| ID | Term |
|---|---|
| C417083 | peginterferon alfa-2b |
| D001800 | Blood Specimen Collection |
| D012254 | Ribavirin |
| C578009 | grazoprevir |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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