Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Myeong Jun Song
With
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
Age
19–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure
