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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02580474
Recruitment Status : Completed
First Posted : October 20, 2015
Last Update Posted : July 18, 2018
Sponsor:
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
Information provided by (Responsible Party):
Myeong Jun Song, The Catholic University of Korea

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

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Daclatasvir plus Asunaprevir Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure
Actual Study Start Date : February 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Daclatasvir

Arm Intervention/treatment
Experimental: Daclatasvir plus Asunaprevir Drug: Daclatasvir plus Asunaprevir



Primary Outcome Measures :
  1. 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 Measures :
  1. To evaluate the percentage of subjects with Sustained Virologic Response at Week 12 After End of Treatment [ Time Frame: 36 Week ]
  2. Percentage of subjects with ALT normalization at each visit from the baseline [ Time Frame: 4, 12, 24, 36 week ]
  3. Change in HCV RNA at each visit from the baseline [ Time Frame: 4, 12, 24, 36 week ]
  4. Percentage of subjects who experience viral breakthrough at each visit from the baseline [ Time Frame: 4, 12, 24, 36 week ]
  5. Percentage of subjects who shows Tolerability of Daclatasvir and Asunaprevir at each visit from [ Time Frame: 4, 12, 24, 36 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580474


Locations
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Korea, Republic of
Myeong Jun Song
Daejeon, Korea, Republic of
Sponsors and Collaborators
Myeong Jun Song
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Myeong Jun Song, Assistant Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT02580474    
Other Study ID Numbers: AI447-118
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Hepatitis C
Renal Insufficiency
Kidney Failure, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Asunaprevir
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action