Efficacy and Safety of Daclatasvir Plus Asunaprevir in Chronic Hepatitis C

Hepatitis C, Chronic Clinical Trial

— ESDAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02639585
• Other study ID #: ESDAC
• Status: Recruiting
• Phase: Phase 4
• First received: December 21, 2015
• Last updated: December 24, 2015
• Start date: December 2015
• Est. completion date: June 2017

Study information

• Verified date: December 2015
• Source: Pusan National University Hospital
• Contact: Won Lim, M.S.
• Phone: +82-10-4513-7063
• Email: ezmagic[@]pusan.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: June 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Daclinza and Sunvepra
direct acting antiviral agent against to hepatitis C virus

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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. — View Citation

Zeuzem S, Jacobson IM, Baykal T, Marinho RT, Poordad F, Bourlière 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Virologic Responase		week 12 (after treatment)	Yes