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

Pusan National University

Status and phase: Unknown; Phase 4

Conditions: Hepatitis C, Chronic

Treatments: Drug: Daclinza and Sunvepra

Study type: Interventional

Funder types: Other

Identifiers

NCT02639585

ESDAC

Details and patient eligibility

About

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

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Treatment arm

Experimental group

Description:

Daclinza and Sunvepra

Treatment:

Drug: Daclinza and Sunvepra