Hepatitis C, ChronicPhase 4ESDACNCT02639585
Efficacy and Safety of Daclatasvir Plus Asunaprevir in Chronic Hepatitis C
A Phase 4 study testing Daclinza and Sunvepra in people with Hepatitis C, Chronic, run by Pusan National University Hospital at 2 sites in South Korea.
Trial summary
We perform this study to identity efficacy and safety of Daclatasvir and Asunaprevir in real practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Daclinza and Sunvepra
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Dec 2015to Jun 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Pusan National University Hospital
Busan, 49241
Won Lim, M.S., +82-51-240-7869, ezmagic@pusan.ac.kr
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, 50612
Young Mi Hong, M.S., 82-55-360-1570, 00gurum@hanmail.net
About this study
Official title: Efficacy and Safety of Daclatasvir Plus Asunaprevir Treatment in Patients With Chronic Hepatitis C : Prospective Cohort Study
We perform this study to identity efficacy and safety of Daclatasvir and Asunaprevir in real practice.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Daclinza and Sunvepra
- Keywords
- daclatasvir, asunaprevir
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daclinza and SunvepraDrug
direct acting antiviral agent against to hepatitis C virus
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Daclinza and Sunvepra Receives: Drug: Daclinza and Sunvepra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virologic Responase
Measured: week 12 (after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionFeb 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Lim, Pusan National University Hospital
- Investigators
- Won Lim, M.S., Principal investigator, Pusan National University HospitalYoung Mi Hong, M.S., Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639585
- Sponsor's protocol ID
- ESDAC
- Acronym
- ESDAC
- Status last verified
- Dec 2015
- First submitted
- 21 Dec 2015
- Last updated
- 28 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24795200Zeuzem 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.
PubMed 24720679Manns 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.
PubMed 25078304
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Daclatasvir Plus Asunaprevir Treatment in Patients With Chronic Hepatitis C : Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02639585
- Acronym / sponsor ID
- ESDAC / ESDAC
- Conditions
- Hepatitis C, Chronic
- Keywords
- daclatasvir, asunaprevir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 24 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We perform this study to identity efficacy and safety of Daclatasvir and Asunaprevir in real practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Daclinza and SunvepraDaclinza and Sunvepra |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daclinza and Sunvepradirect acting antiviral agent against to hepatitis C virus | Drug | Treatment arm |
Primary outcome
Sustained Virologic Responase
Time frame: week 12 (after treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2015.
- Background: PubMed 24795200Ferenci 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.
- Background: PubMed 24720679Zeuzem 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.
- Background: PubMed 25078304Manns 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Won Lim, M.S. principal investigator
Pusan National University Hospital
Young Mi Hong, M.S. principal investigator
Pusan National University Yangsan Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Daclinza and Sunvepra in people with Hepatitis C, Chronic, run by Pusan National University Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Won Lim, M.S. (+82-10-4513-7063, ezmagic@pusan.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Virologic Responase (time frame: week 12 (after treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02639585, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2015.