Efficacy and Safety of Daclatasvir Plus Asunaprevir in Chronic Hepatitis C

NCT02639585 | Unknown Phase 4

• 1 other identifier: ESDAC
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Hepatitis C, Chronic

Keywords

daclatasvir; asunaprevir

Outcome Measures

Primary Outcomes (1)

• Sustained Virologic Responase

  week 12 (after treatment)

Study Arms (1)

Treatment arm

EXPERIMENTAL

Daclinza and Sunvepra

Drug: Daclinza and Sunvepra

Interventions

Daclinza and Sunvepra DRUG

direct acting antiviral agent against to hepatitis C virus

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (2)

Pusan National University Hospital

Busan, 49241, South Korea

RECRUITING

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

RECRUITING

Related 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.

  PMID: 24795200 BACKGROUND

• 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.

  PMID: 24720679 BACKGROUND

• 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.

  PMID: 25078304 BACKGROUND

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Won Lim, M.S.

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

• Young Mi Hong, M.S.

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Won Lim, M.S.

CONTACT

+82-10-4513-7063; ezmagic@pusan.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Internal Medicine

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: December 24, 2015
• Study Start: December 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: June 1, 2017
• Last Updated: December 28, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)