Hepatitis CNCT02727933
Postmarketing Surveillance of the Safety and Effectiveness of Daclatasvir and Asunaprevir for the Treatment of Chronic HCV Genotype 1B Infection in the Routine Clinical Practice in Korea
An observational study of Hepatitis C, run by Bristol-Myers Squibb at 1 site in South Korea.
Trial summary
The primary objective of this study is to describe the safety of the combination of Daklinza (daclatasvir) and Sunvepra (asunaprevir) when used for the treatment of chronic hepatitis C (CHC) genotype 1b patients in real-life conditions when used according to its registered indications. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hepatitis C
- How many people
- 1,941 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Nov 2015to 5 Jul 2020
- How long will I take part?
- 6 Years
- Phase
- Observational
- 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
Study population: Primary Care Clinic
Who may be able to join
- Patients with CHC genotype 1b and compensated liver disease, including cirrhotic patients
- Eligible for treatment with Daklinza and Sunvepra as indicated in the locally approved prescribing information.
Who cannot join
- Off-label use of Daklinza and Sunvepra
- Patients with a contraindication for the use of Daklinza and Sunvepra as described in the locally approved prescribing information
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to describe the safety of the combination of Daklinza (daclatasvir) and Sunvepra (asunaprevir) when used for the treatment of chronic hepatitis C (CHC) genotype 1b patients in real-life conditions when used according to its registered indications.
- Conditions
- Hepatitis C
- Medical subject headings
- Hepatitis C
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of expected and unexpected adverse reactions (AEs) and serious adverse events (SAEs)/reactions. These include laboratory abnormalities
Measured: 6 months to 5 years
Secondary outcomes (5)
Incidence proportion of AEs leading to discontinuation of study therapy
Measured: 6 months to 5 years
Incidence rate of AEs leading to discontinuation of study therapy
Measured: 6 months to 5 years
Timing of laboratory abnormalities by toxicity grade
Measured: 6 months to 5 years
Percentage of patients with HCV (Hepatitis C Virus) RNA (Ribonucleic acid)< lower limit of quantification (LLQ) target not detected and detected
Measured: 4 Weeks to 24 Weeks
The sustained virologic response (SVR12) of the combination of Daklinza and Sunvepra (HCV RNA < lower limit of quantification [LLQ] target not detected and detected (HCV RNA < 25 IU/mL)
Measured: 24 Weeks to 36 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study start3 Nov 2015
- Primary completion5 Jul 2020
- Study completion5 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,941 participants (actual)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727933
- Sponsor's protocol ID
- AI444-335
- Status last verified
- Dec 2021
- First submitted
- 18 Mar 2016
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postmarketing Surveillance of the Safety and Effectiveness of Daclatasvir and Asunaprevir for the Treatment of Chronic HCV Genotype 1B Infection in the Routine Clinical Practice in Korea
- ClinicalTrials.gov ID
- NCT02727933
- Acronym / sponsor ID
- AI444-335
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,941 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2015 (actual)
- Primary completion
- 5 Jul 2020 (actual)
- Study completion
- 5 Jul 2020 (actual)
- First posted
- 5 Apr 2016 (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.
The primary objective of this study is to describe the safety of the combination of Daklinza (daclatasvir) and Sunvepra (asunaprevir) when used for the treatment of chronic hepatitis C (CHC) genotype 1b patients in real-life conditions when used according to its registered indications.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Years
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (2 listed)
- Patients with CHC genotype 1b and compensated liver disease, including cirrhotic patients
- Eligible for treatment with Daklinza and Sunvepra as indicated in the locally approved prescribing information.
Key exclusion criteria (2 listed)
- Off-label use of Daklinza and Sunvepra
- Patients with a contraindication for the use of Daklinza and Sunvepra as described in the locally approved prescribing information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of expected and unexpected adverse reactions (AEs) and serious adverse events (SAEs)/reactions. These include laboratory abnormalities
Time frame: 6 months to 5 years
5 secondary outcomes
Incidence proportion of AEs leading to discontinuation of study therapy
Time frame: 6 months to 5 years
Incidence rate of AEs leading to discontinuation of study therapy
Time frame: 6 months to 5 years
Timing of laboratory abnormalities by toxicity grade
Time frame: 6 months to 5 years
Percentage of patients with HCV (Hepatitis C Virus) RNA (Ribonucleic acid)< lower limit of quantification (LLQ) target not detected and detected
Time frame: 4 Weeks to 24 Weeks
The sustained virologic response (SVR12) of the combination of Daklinza and Sunvepra (HCV RNA < lower limit of quantification [LLQ] target not detected and detected (HCV RNA < 25 IU/mL)
Time frame: 24 Weeks to 36 Weeks
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 21 Jan 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Bristol-Myers Squibb 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 2 inclusion and 2 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 21 Jan 2022. 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.
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?
Frequency of expected and unexpected adverse reactions (AEs) and serious adverse events (SAEs)/reactions. These include laboratory abnormalities (time frame: 6 months to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2022.