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

Myeong Jun Song

Status and phase: Completed; Phase 4

Conditions: Hepatitis C

Treatments: Drug: Daclatasvir plus Asunaprevir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02580474

AI447-118

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Daclatasvir plus Asunaprevir

Experimental group

Treatment:

Drug: Daclatasvir plus Asunaprevir