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

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

Study Overview

• Status: Completed
• Conditions: Hepatitis C
• Intervention / Treatment: Drug: Daclatasvir plus Asunaprevir

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of
    • Myeong Jun Song

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Daclatasvir plus Asunaprevir	Drug: Daclatasvir plus Asunaprevir

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Lee BS, Song MJ, Kwon JH, Lee TH, Jang JW, Kim SH, Lee SH, Kim HS, Kim JH, Kim SB, Ko SY, Song DS. Efficacy and Safety of Daclatasvir and Asunaprevir in Patients with Hepatitis C Virus Genotype 1b Infection on Hemodialysis. Gut Liver. 2019 Mar 15;13(2):191-196. doi: 10.5009/gnl18240.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: October 16, 2015
• First Submitted That Met QC Criteria: October 16, 2015
• First Posted (Estimate): October 20, 2015

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Kidney Diseases; Urologic Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Renal Insufficiency, Chronic; Hepatitis; Hepatitis C; Kidney Failure, Chronic; Renal Insufficiency; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Asunaprevir
• Other Study ID Numbers: AI447-118