Hepatitis CPhase 4NCT02580474
The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure
A Phase 4 study testing Daclatasvir plus Asunaprevir in people with Hepatitis C, run by Myeong Jun Song at 1 site in South Korea.
Trial summary
Safety and Efficacy of DAAs (Daclatasvir+Asunaprevir) in patients with chronic hepatitis C and chronic renal failure will be assessed. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Daclatasvir plus Asunaprevir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2016to Apr 2018
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HCV RNA Positive and Genotype 1b
- No history or signs or symptoms of decompensated liver disease or hepatocellular carcinoma within 6 months
- A patient who is on dialysis, or if not MDRD eGFR<30ml/min
- HCV treatment history: HCV treatment-naive participants, defined as never having received HCV treatment with any approved or investigational drug (including vaccines); OR HCV treatment-experienced, defined as having received previous HCV treatment with any (pegylated) interferon ([Peg]IFN)-based drug regimen (with or without ribavirin [RBV] and not including a direct-acting antiviral agent [DAA]). Last dose in this previous HCV treatment course should have occurred at least 2 months prior to screening
- No baseline mutation NS5A polymorphism including L31F/I/M/V and Y93H
Who cannot join
- A patient who having received Daclatasvir or Asunaprevir
- Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study
- Evidence of a medical condition contributing to chronic liver disease other than HCV or seropositive for HIV
- Diagnosed or suspected hepatocellular carcinoma or other malignancies
- Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage)
- Received solid organ or bone marrow transplant
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- Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance
- Significant renal, cardiovascular, pulmonary, or neurological disease and uncontrolled diabetes or hypertension in the opinion of the investigator
- Known hypersensitivity to study drugs, metabolites, or formulation excipients
- Who has taken investigational drugs within 2 months.
Trial locations and contacts
1 site in 1 country.
About this study
Safety and Efficacy of DAAs (Daclatasvir+Asunaprevir) in patients with chronic hepatitis C and chronic renal failure will be assessed.
- Conditions
- Hepatitis C
- Being tested
- Daclatasvir plus Asunaprevir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daclatasvir plus AsunaprevirDrug
| Study group | Role | What they receive |
|---|---|---|
| Daclatasvir plus Asunaprevir | Experimental | Not described Receives: Drug: Daclatasvir plus Asunaprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of subjects with plasma HCV RNA levels below 15 IU/mL at Week 12 After End of Treatment
Measured: 36 Week
Secondary outcomes (5)
To evaluate the percentage of subjects with Sustained Virologic Response at Week 12 After End of Treatment
Measured: 36 Week
Percentage of subjects with ALT normalization at each visit from the baseline
Measured: 4, 12, 24, 36 week
Change in HCV RNA at each visit from the baseline
Measured: 4, 12, 24, 36 week
Percentage of subjects who experience viral breakthrough at each visit from the baseline
Measured: 4, 12, 24, 36 week
Percentage of subjects who shows Tolerability of Daclatasvir and Asunaprevir at each visit from
Measured: 4, 12, 24, 36 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startFeb 2016
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myeong Jun Song
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Soonchunhyang University Hospital, Dankook University, Chungnam National University Hospital, Konyang University Hospital, Eulji University Hospital, Saint Vincent's Hospital, Korea, Konkuk University Hospital, Cheongju St. Mary's Hospital, Cheongju, Korea, Severance Hospital, Korea University Guro Hospital, Eulji General Hospital
- Responsible party
- Sponsor-investigator, Myeong Jun Song, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580474
- Sponsor's protocol ID
- AI447-118
- Status last verified
- Jul 2018
- First submitted
- 16 Oct 2015
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee BS, Song MJ, Kwon JH, Lee TH, Jang JW, Kim SH, Lee SH, Kim HS, Kim JH, Kim SB, Ko SY, Song DS. Efficacy and Safety of Daclatasvir and Asunaprevir in Patients with Hepatitis C Virus Genotype 1b Infection on Hemodialysis. Gut Liver. 2019 Mar 15;13(2):191-196. doi: 10.5009/gnl18240.
PubMed 30400729
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Daclatasvir and Asunaprevir With Chronic HCV Genotype 1b Infection and Chronic Renal Failure
- ClinicalTrials.gov ID
- NCT02580474
- Acronym / sponsor ID
- AI447-118
- Conditions
- Hepatitis C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Myeong Jun SongUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Soonchunhyang University Hospital, Dankook University, Chungnam National University Hospital, Konyang University Hospital, Eulji University Hospital, Saint Vincent's Hospital, Korea, Konkuk University Hospital, Cheongju St. Mary's Hospital, Cheongju, Korea, Severance Hospital, Korea University Guro Hospital, Eulji General Hospital
- Study start
- Feb 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 20 Oct 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.
Safety and Efficacy of DAAs (Daclatasvir+Asunaprevir) in patients with chronic hepatitis C and chronic renal failure will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daclatasvir plus Asunaprevir | Experimental | Drug: Daclatasvir plus Asunaprevir |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HCV RNA Positive and Genotype 1b
- No history or signs or symptoms of decompensated liver disease or hepatocellular carcinoma within 6 months
- A patient who is on dialysis, or if not MDRD eGFR<30ml/min
- HCV treatment history: HCV treatment-naive participants, defined as never having received HCV treatment with any approved or investigational drug (including vaccines); OR HCV treatment-experienced, defined as having received previous HCV treatment with any (pegylated) interferon ([Peg]IFN)-based drug regimen (with or without ribavirin [RBV] and not including a direct-acting antiviral agent [DAA]). Last dose in this previous HCV treatment course should have occurred at least 2 months prior to screening
- No baseline mutation NS5A polymorphism including L31F/I/M/V and Y93H
Key exclusion criteria (10 listed)
- A patient who having received Daclatasvir or Asunaprevir
- Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study
- Evidence of a medical condition contributing to chronic liver disease other than HCV or seropositive for HIV
- Diagnosed or suspected hepatocellular carcinoma or other malignancies
- Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage)
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 |
|---|---|---|
| Daclatasvir plus Asunaprevir | Drug | Daclatasvir plus Asunaprevir |
Primary outcome
the proportion of subjects with plasma HCV RNA levels below 15 IU/mL at Week 12 After End of Treatment
Time frame: 36 Week
5 secondary outcomes
To evaluate the percentage of subjects with Sustained Virologic Response at Week 12 After End of Treatment
Time frame: 36 Week
Percentage of subjects with ALT normalization at each visit from the baseline
Time frame: 4, 12, 24, 36 week
Change in HCV RNA at each visit from the baseline
Time frame: 4, 12, 24, 36 week
Percentage of subjects who experience viral breakthrough at each visit from the baseline
Time frame: 4, 12, 24, 36 week
Percentage of subjects who shows Tolerability of Daclatasvir and Asunaprevir at each visit from
Time frame: 4, 12, 24, 36 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Derived from this study: PubMed 30400729Lee BS, Song MJ, Kwon JH, Lee TH, Jang JW, Kim SH, Lee SH, Kim HS, Kim JH, Kim SB, Ko SY, Song DS. Efficacy and Safety of Daclatasvir and Asunaprevir in Patients with Hepatitis C Virus Genotype 1b Infection on Hemodialysis. Gut Liver. 2019 Mar 15;13(2):191-196. doi: 10.5009/gnl18240.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Daclatasvir plus Asunaprevir in people with Hepatitis C, run by Myeong Jun Song at 1 site 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of subjects with plasma HCV RNA levels below 15 IU/mL at Week 12 After End of Treatment (time frame: 36 Week). 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 NCT02580474, which also lists 1 linked publication.
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 18 Jul 2018.