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

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Daclatasvir plus Asunaprevir
Sponsored by
Myeong Jun Song
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Myeong Jun Song

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Daclatasvir plus Asunaprevir

Arm Description

Outcomes

Primary Outcome Measures

the proportion of subjects with plasma HCV RNA levels below 15 IU/mL at Week 12 After End of Treatment

Secondary Outcome Measures

To evaluate the percentage of subjects with Sustained Virologic Response at Week 12 After End of Treatment
Percentage of subjects with ALT normalization at each visit from the baseline
Change in HCV RNA at each visit from the baseline
Percentage of subjects who experience viral breakthrough at each visit from the baseline
Percentage of subjects who shows Tolerability of Daclatasvir and Asunaprevir at each visit from

Full Information

First Posted
October 16, 2015
Last Updated
July 17, 2018
Sponsor
Myeong Jun Song
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT02580474
Brief Title
The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure
Official Title
The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Myeong Jun Song
Collaborators
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daclatasvir plus Asunaprevir
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Daclatasvir plus Asunaprevir
Primary Outcome Measure Information:
Title
the proportion of subjects with plasma HCV RNA levels below 15 IU/mL at Week 12 After End of Treatment
Time Frame
36 Week
Secondary Outcome Measure Information:
Title
To evaluate the percentage of subjects with Sustained Virologic Response at Week 12 After End of Treatment
Time Frame
36 Week
Title
Percentage of subjects with ALT normalization at each visit from the baseline
Time Frame
4, 12, 24, 36 week
Title
Change in HCV RNA at each visit from the baseline
Time Frame
4, 12, 24, 36 week
Title
Percentage of subjects who experience viral breakthrough at each visit from the baseline
Time Frame
4, 12, 24, 36 week
Title
Percentage of subjects who shows Tolerability of Daclatasvir and Asunaprevir at each visit from
Time Frame
4, 12, 24, 36 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Myeong Jun Song
City
Daejeon
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
30400729
Citation
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.
Results Reference
derived

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

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