Chronic Hepatitis CNCT03500562
Study of Daclatasvir-based Therapy in Chinese Participants With Chronic Hepatitis C (CHC)
An observational study of Chronic Hepatitis C, run by Bristol-Myers Squibb at 2 sites in China.
Trial summary
Study is a non-interventional, prospective, multicenter post marketing surveillance study to determine the safety of daclatasvir based therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- How many people
- 3 participants
- Where
- 2 sitesChina
- Study dates
- 8 May 2018to 29 Mar 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who receive branded DCV-based therapy in the real-world treatment setting for the first time under the approved indications.
Who may be able to join
- Participants 18 years of age and older
- Participants with Chronic Hepatitis C virus (CHC) who are eligible for treatment with branded DCV-based therapy as indicated in the locally approved label
Who cannot join
- Participants under the age of 18
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
2 sites in 1 country.
China2 sites
Local Institution
Beijing, Beijing Municipality, 100054
Local Institution
Guangzhou, Guangdong, 510515
About this study
Official title: Daclatasvir-Based Therapy Safety Surveillance in Chinese Patients With Chronic Hepatitis C
Study is a non-interventional, prospective, multicenter post marketing surveillance study to determine the safety of daclatasvir based therapy
- Conditions
- Chronic Hepatitis C
- 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.
| Study group | Role | What they receive |
|---|---|---|
| HCV participant population in China | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events (AEs)
Measured: Approximately 72 weeks
Number of serious adverse events (SAEs)
Measured: Approximately 72 weeks
Secondary outcomes (2)
Number of participants who discontinue therapy due to an AE
Measured: Approximately 72 weeks
Effectiveness of daclatasvir DCV-based therapy
As measured by Sustained virologic response 12 weeks after the end of treatment (SVR12) Achieved SVR12: Hepatitis C virus (HCV) RNA below the lower limit of quantification (LLOQ)
Measured: Approximately 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start8 May 2018
- Primary completion29 Mar 2019
- Study completion29 Mar 2019
Why it stopped: Insufficient Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
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
- NCT03500562
- Sponsor's protocol ID
- AI444-396
- Status last verified
- Aug 2021
- First submitted
- 10 Apr 2018
- Last updated
- 1 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daclatasvir-Based Therapy Safety Surveillance in Chinese Patients With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT03500562
- Acronym / sponsor ID
- AI444-396
- Conditions
- Chronic Hepatitis C
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient Enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 8 May 2018 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 29 Mar 2019 (actual)
- First posted
- 18 Apr 2018 (actual)
- 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.
Study is a non-interventional, prospective, multicenter post marketing surveillance study to determine the safety of daclatasvir based therapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCV participant population in China | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who receive branded DCV-based therapy in the real-world treatment setting for the first time under the approved indications.
Key inclusion criteria (2 listed)
- Participants 18 years of age and older
- Participants with Chronic Hepatitis C virus (CHC) who are eligible for treatment with branded DCV-based therapy as indicated in the locally approved label
Key exclusion criteria (2 listed)
- Participants under the age of 18
- Other protocol defined inclusion/exclusion criteria could apply
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
Number of adverse events (AEs)
Time frame: Approximately 72 weeks
Number of serious adverse events (SAEs)
Time frame: Approximately 72 weeks
2 secondary outcomes
Number of participants who discontinue therapy due to an AE
Time frame: Approximately 72 weeks
Effectiveness of daclatasvir DCV-based therapy
Time frame: Approximately 72 weeks
Results and safety
The study was stopped early (reason given: Insufficient Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
Related trials for Chronic Hepatitis C
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis C, run by Bristol-Myers Squibb at 2 sites in China.
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: stopped early, as of the sponsor's last update on 1 Sep 2021. 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 China. 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 was stopped early (reason given: Insufficient Enrollment). Results are not available in the source record.
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?
Number of adverse events (AEs) (time frame: Approximately 72 weeks). The study lists 2 primary outcomes in all. 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 1 Sep 2021.