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Efficacy and Safety of Daclatasvir Plus Asunaprevir in Chronic Hepatitis C (ESDAC)

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: NCT02639585
Recruitment Status : Unknown
Verified December 2015 by Won Lim, Pusan National University Hospital.
Recruitment status was:  Recruiting
First Posted : December 24, 2015
Last Update Posted : December 28, 2015
Sponsor:
Information provided by (Responsible Party):
Won Lim, Pusan National University Hospital

Brief Summary:
We perform this study to identity efficacy and safety of Daclatasvir and Asunaprevir in real practice.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: Daclinza and Sunvepra Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Daclatasvir Plus Asunaprevir Treatment in Patients With Chronic Hepatitis C : Prospective Cohort Study
Study Start Date : December 2015
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Daclatasvir

Arm Intervention/treatment
Experimental: Treatment arm
Daclinza and Sunvepra
Drug: Daclinza and Sunvepra
direct acting antiviral agent against to hepatitis C virus




Primary Outcome Measures :
  1. Sustained Virologic Responase [ Time Frame: week 12 (after treatment) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing and able to provide written informed consent
  2. Males and females, ≥ 18 years of age
  3. HCV Genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, OR intolerant or ineligible to P/R due to neutropenia, anemia, depression or thrombocytopenia with fibrosis/cirrhosis, OR treatment naive
  4. HCV RNA ≥ 10,000 IU/mL
  5. Subjects with compensated cirrhosis are permitted
  6. Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg)
  7. Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug. Additionally, all fertile males with partners of childbearing age and all females with childbearing potential must use reliable contraception method during the study and for 3 months after treatment completion.

Exclusion Criteria:

  1. Inability or unwillingness to provide informed consent or abide by the requirements of the study
  2. Other than genotype 1 infection
  3. Prior treatment of HCV with HCV direct acting antiviral agents (DAA)
  4. Patient who has any history of major organ transplantation with an existing functional graft or Patient who has plan to receive organ transplant
  5. Diagnosed or suspected hepatocellular carcinoma or other malignancies
  6. Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
  7. Evidence of a medical condition contributing to chronic liver disease other than HCV
  8. Uncontrolled diabetes or hypertension
  9. Women with ongoing pregnancy or who are breast feeding
  10. Evidence of alcohol and/or drug abuse
  11. Patient who has NS5A resistance associated variant

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): NCT02639585


Contacts
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Contact: Won Lim, M.S. +82-10-4513-7063 ezmagic@pusan.ac.kr

Locations
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Korea, Republic of
Pusan National University Hospital Recruiting
Busan, Korea, Republic of, 49241
Contact: Won Lim, M.S.    +82-51-240-7869    ezmagic@pusan.ac.kr   
Pusan National University Yangsan Hospital Recruiting
Yangsan, Korea, Republic of, 50612
Contact: Young Mi Hong, M.S.    82-55-360-1570    00gurum@hanmail.net   
Sponsors and Collaborators
Pusan National University Hospital
Investigators
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Principal Investigator: Won Lim, M.S. Pusan National University Hospital
Principal Investigator: Young Mi Hong, M.S. Pusan National University Yangsan Hospital

Publications:
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Responsible Party: Won Lim, Assistant Professor, Department of Internal Medicine, Pusan National University Hospital
ClinicalTrials.gov Identifier: NCT02639585     History of Changes
Other Study ID Numbers: ESDAC
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: December 28, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Won Lim, Pusan National University Hospital:
daclatasvir
asunaprevir
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Asunaprevir
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action