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

Primary Purpose

Hepatitis C, Chronic

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Daclinza and Sunvepra

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring daclatasvir, asunaprevir

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Willing and able to provide written informed consent
Males and females, ≥ 18 years of age
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
HCV RNA ≥ 10,000 IU/mL
Subjects with compensated cirrhosis are permitted
Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg)
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:

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

Sites / Locations

Pusan National University HospitalRecruiting
Pusan National University Yangsan HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment arm

Arm Description

Daclinza and Sunvepra

Outcomes

Primary Outcome Measures

Sustained Virologic Responase

Secondary Outcome Measures

Full Information

NCT ID

NCT02639585

First Posted

December 21, 2015

Last Updated

December 24, 2015

Sponsor

Pusan National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02639585

Brief Title

Efficacy and Safety of Daclatasvir Plus Asunaprevir in Chronic Hepatitis C

Acronym

ESDAC

Official Title

Efficacy and Safety of Daclatasvir Plus Asunaprevir Treatment in Patients With Chronic Hepatitis C : Prospective Cohort Study

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Unknown status

Study Start Date

December 2015 (undefined)

Primary Completion Date

February 2017 (Anticipated)

Study Completion Date

June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pusan National University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

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

Hepatitis C, Chronic

Keywords

daclatasvir, asunaprevir

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment arm

Arm Type

Experimental

Arm Description

Daclinza and Sunvepra

Intervention Type

Drug

Intervention Name(s)

Daclinza and Sunvepra

Intervention Description

direct acting antiviral agent against to hepatitis C virus

Primary Outcome Measure Information:

Title

Sustained Virologic Responase

Time Frame

week 12 (after treatment)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Willing and able to provide written informed consent Males and females, ≥ 18 years of age 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 HCV RNA ≥ 10,000 IU/mL Subjects with compensated cirrhosis are permitted Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg) 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: Inability or unwillingness to provide informed consent or abide by the requirements of the study Other than genotype 1 infection Prior treatment of HCV with HCV direct acting antiviral agents (DAA) Patient who has any history of major organ transplantation with an existing functional graft or Patient who has plan to receive organ transplant Diagnosed or suspected hepatocellular carcinoma or other malignancies Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy Evidence of a medical condition contributing to chronic liver disease other than HCV Uncontrolled diabetes or hypertension Women with ongoing pregnancy or who are breast feeding Evidence of alcohol and/or drug abuse Patient who has NS5A resistance associated variant

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Won Lim, M.S.

Phone

+82-10-4513-7063

ezmagic@pusan.ac.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Won Lim, M.S.

Organizational Affiliation

Pusan National University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Young Mi Hong, M.S.

Organizational Affiliation

Pusan National University Yangsan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pusan National University Hospital

City

Busan

ZIP/Postal Code

49241

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Won Lim, M.S.

Phone

+82-51-240-7869

ezmagic@pusan.ac.kr

Facility Name

Pusan National University Yangsan Hospital

City

Yangsan

ZIP/Postal Code

50612

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Young Mi Hong, M.S.

Phone

82-55-360-1570

00gurum@hanmail.net

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24795200

Citation

Ferenci P, Bernstein D, Lalezari J, Cohen D, Luo Y, Cooper C, Tam E, Marinho RT, Tsai N, Nyberg A, Box TD, Younes Z, Enayati P, Green S, Baruch Y, Bhandari BR, Caruntu FA, Sepe T, Chulanov V, Janczewska E, Rizzardini G, Gervain J, Planas R, Moreno C, Hassanein T, Xie W, King M, Podsadecki T, Reddy KR; PEARL-III Study; PEARL-IV Study. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med. 2014 May 22;370(21):1983-92. doi: 10.1056/NEJMoa1402338. Epub 2014 May 4.

Results Reference

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PubMed Identifier

24720679

Citation

Zeuzem S, Jacobson IM, Baykal T, Marinho RT, Poordad F, Bourliere M, Sulkowski MS, Wedemeyer H, Tam E, Desmond P, Jensen DM, Di Bisceglie AM, Varunok P, Hassanein T, Xiong J, Pilot-Matias T, DaSilva-Tillmann B, Larsen L, Podsadecki T, Bernstein B. Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med. 2014 Apr 24;370(17):1604-14. doi: 10.1056/NEJMoa1401561. Epub 2014 Apr 10.

Results Reference

background

PubMed Identifier

25078304

Citation

Manns M, Pol S, Jacobson IM, Marcellin P, Gordon SC, Peng CY, Chang TT, Everson GT, Heo J, Gerken G, Yoffe B, Towner WJ, Bourliere M, Metivier S, Chu CJ, Sievert W, Bronowicki JP, Thabut D, Lee YJ, Kao JH, McPhee F, Kopit J, Mendez P, Linaberry M, Hughes E, Noviello S; HALLMARK-DUAL Study Team. All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study. Lancet. 2014 Nov 1;384(9954):1597-605. doi: 10.1016/S0140-6736(14)61059-X. Epub 2014 Jul 28. Erratum In: Lancet. 2014 Nov 1;384(9954):1576.

Results Reference

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Efficacy and Safety of Daclatasvir Plus Asunaprevir in Chronic Hepatitis C

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