Hepatitis C
Conditions
Brief summary
Safety and Efficacy of DAAs (Daclatasvir+Asunaprevir) in patients with chronic hepatitis C and chronic renal failure will be assessed.
Interventions
DRUGDaclatasvir plus Asunaprevir
Sponsors
Bristol-Myers Squibb
Soonchunhyang University Hospital
Dankook University
Chungnam National University Hospital
Konyang University Hospital
Eulji University Hospital
Saint Vincent's Hospital, Korea
Konkuk University Hospital
Cheongju St. Mary's Hospital, Cheongju, Korea
Severance Hospital
Korea University Guro Hospital
Eulji General Hospital
Myeong Jun Song
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
South Korea
Outcome results
None listed