The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure

Study Overview
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Brief Summary
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Safety and Efficacy of DAAs (Daclatasvir+Asunaprevir) in patients with chronic hepatitis C and chronic renal failure will be assessed.

Official Title
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The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Daclatasvir plus Asunaprevir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HCV RNA Positive and Genotype 1b No history or signs or symptoms of decompensated liver disease or hepatocellular carcinoma within 6 months A patient who is on dialysis, or if not MDRD eGFR<30ml/min HCV treatment history: HCV treatment-naive participants, defined as never having received HCV treatment with any approved or investigational drug (including vaccines); OR HCV treatment-experienced, defined as having received previous HCV treatment with any (pegylated) interferon ([Peg]IFN)-based drug regimen (with or without ribavirin [RBV] and not including a direct-acting antiviral agent [DAA]). Last dose in this previous HCV treatment course should have occurred at least 2 months prior to screening No baseline mutation NS5A polymorphism including L31F/I/M/V and Y93H Exclusion Criteria: A patient who having received Daclatasvir or Asunaprevir Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study Evidence of a medical condition contributing to chronic liver disease other than HCV or seropositive for HIV Diagnosed or suspected hepatocellular carcinoma or other malignancies Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage) Received solid organ or bone marrow transplant Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance Significant renal, cardiovascular, pulmonary, or neurological disease and uncontrolled diabetes or hypertension in the opinion of the investigator Known hypersensitivity to study drugs, metabolites, or formulation excipients Who has taken investigational drugs within 2 months.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daclatasvir plus Asunaprevir<br> | Drug: Daclatasvir plus Asunaprevir<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of subjects with plasma HCV RNA levels below 15 IU/mL at Week 12 After End of Treatment |  | 36 Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the percentage of subjects with Sustained Virologic Response at Week 12 After End of Treatment |  | 36 Week | 
| Percentage of subjects with ALT normalization at each visit from the baseline |  | 4, 12, 24, 36 week | 
| Change in HCV RNA at each visit from the baseline |  | 4, 12, 24, 36 week | 
| Percentage of subjects who experience viral breakthrough at each visit from the baseline |  | 4, 12, 24, 36 week | 
| Percentage of subjects who shows Tolerability of Daclatasvir and Asunaprevir at each visit from |  | 4, 12, 24, 36 week |