Efficacy and Safety of Daclatasvir Plus Asunaprevir in Chronic Hepatitis C
NCT ID: NCT02639585
Last Updated: 2015-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
32 participants
INTERVENTIONAL
2015-12-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment arm
Daclinza and Sunvepra
Daclinza and Sunvepra
direct acting antiviral agent against to hepatitis C virus
Interventions
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Daclinza and Sunvepra
direct acting antiviral agent against to hepatitis C virus
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Pusan National University Hospital
OTHER
Responsible Party
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Won Lim
Assistant Professor, Department of Internal Medicine
Principal Investigators
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Won Lim, M.S.
Role: PRINCIPAL_INVESTIGATOR
Pusan National University Hospital
Young Mi Hong, M.S.
Role: PRINCIPAL_INVESTIGATOR
Pusan National University Yangsan Hospital
Locations
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Pusan National University Hospital
Busan, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Won Lim, M.S.
Role: primary
Young Mi Hong, M.S.
Role: primary
References
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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.
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.
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.
Other Identifiers
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ESDAC
Identifier Type: -
Identifier Source: org_study_id