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

• Status: Completed
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Myeong Jun Song
• Collaborators: Bristol-Myers Squibb; Cheongju St. Mary's Hospital, Cheongju, Korea; Chungnam National University Hospital; Dankook University; Eulji General Hospital; Eulji University Hospital; Konkuk University Hospital; Konyang University Hospital; Korea University Guro Hospital; Saint Vincent's Hospital, Korea; Severance Hospital; Soonchunhyang University Hospital
• Treatments: Asunaprevir

Criteria

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.