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CryoKid is a no-profit, multi-center, single-arm, open-label, pilot study. The study aims to evaluate the tolerability of MK-8742 (Elbasvir) / MK-5172 (Grazoprevir) administrated for 12 weeks without Ribavirin in patients with HCV chronic hepatitis (G1b and G4) and cryoglobulinemic nephropathy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elbasvir/Grazoprevir | Drug | Administration of MK-8742 (Elbasvir)/MK-5172 (Grazoprevir) for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| SVR12 | Percentage of participants achieving sustained virologic response 12 weeks after completing treatment (SVR12) | march 2018-october 2018 |
| Measure | Description | Time Frame |
|---|---|---|
| SVR24 | Percentage of participants achieving Sustained Virologic Response 24 weeks after ending study treatment (SVR 24) | march 2018-december 2018 |
| Clinical response: improvement or disappearance of MC clinical and biochemical stigmata |
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Inclusion Criteria:
Exclusion Criteria:
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G1b and G4 patients with HCV-related Cryoglobulinemic Nephropathy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ANNA LINDA ZIGNEGO, MD, PhD | Contact | +390552758 | 020 | annalinda.zignego@unifi.it |
| MONICA MONTI, PhD | Contact | +390552758 | 088 | monica.monti@unifi.it |
| Name | Affiliation | Role |
|---|---|---|
| ANNA LINDA ZIGNEGO, MD, PhD | University of Florence | Principal Investigator |
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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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Clinical response: improvement or disappearance of MC clinical and biochemical stigmata at the EOT, at week 12 and week 24 of follow-up. Improvement of the renal function at week 4, week 8, EOT at week 12 and week 24 of follow-up.
| march 2018-december 2018 |
| Tolerability: Number of participants experiencing an adverse event (AE) | Tolerability: Number of participants experiencing an adverse event (AE) | march 2018-may 2018 |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |