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UNKNOWNPhase 4NCT02639585

Efficacy and Safety of Daclatasvir Plus Asunaprevir in Chronic Hepatitis C

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

Lead sponsor: Pusan National University Hospital•2 locations•View source on ClinicalTrials.gov

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Contacts

Won Lim, M.S.

CONTACT

+82-10-4513-7063 ezmagic@pusan.ac.kr

Sponsors

Lead Sponsor

Pusan National University Hospital

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 28, 2015Terms

Trial snapshot

StatusUNKNOWN

PhasePHASE4

Enrollment32

Start dateDec 2015

Last updatedDec 28, 2015

Condition

Hepatitis C, Chronic

Locations shown

Pusan National University Hospital

Busan

Pusan National University Yangsan Hospital

Yangsan

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 28, 2015Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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