Clinical trial NCT02639585: Efficacy and Safety of Daclatasvir Plus Asunaprevir in Chronic Hepatitis C
Official title: Efficacy and Safety of Daclatasvir Plus Asunaprevir Treatment in Patients With Chronic Hepatitis C : Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Keywords: daclatasvir
asunaprevir
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2015-12-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Sustained Virologic Responase
timeFrame: week 12 (after treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Pusan National University Hospital
name: Won Lim, M.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: Pusan National University Yangsan Hospital
name: Young Mi Hong, M.S.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.