Hepatitis CNCT03071133
Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy
An observational study of Hepatitis C, run by Bristol-Myers Squibb at 1 site in Japan.
Trial summary
An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis C
- How many people
- 344 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jan 2018to 8 Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients in Japan who are initiating treatment with DCV Trio therapy
Who may be able to join
- Patients who are initiating the treatment with DCV Trio therapy under the approved indications, dosage, and administration
Who cannot join
- Patients who use the DCV Trio off label
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Asunaprevir/Daclatasvir/Beclabuvir Fixed-Dose Combination Safety Surveillance in Japanese Patients With Chronic Hepatitis C (HCV) or Japanese Patients With Compensated Cirrhosis
An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan
- 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.
Incidence of Aspartate Aminotransferase (AST) elevation
measured by immunoassay
Measured: Up to 36 weeks
Incidence of Alanine Aminotransferase (ALT) elevation
measured by immunoassay
Measured: Up to 36 weeks
Incidence of Total Bilirubin (tBili) elevation
measured by immunoassay
Measured: Up to 36 weeks
Secondary outcomes (4)
Incidence of adverse drug reactions (ADRs) in HCV patients treated with DCV Trio therapy in Japan
measured by adverse events
Measured: Up to 36 weeks
Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12)
measured by number of patients
Measured: Up to 24 weeks
Proportion of patients with undetectable HCV RNA at 24 weeks post-treatment (SVR24)
measured by number of patients
Measured: Up to 36 weeks
Percentage of patients to experience virologic breakthrough
measured by percentage of patients
Measured: Up 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 posted6 Mar 2017
- Study start1 Jan 2018
- Primary completion8 Jan 2019
- Study completion8 Jan 2019
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 344 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
- NCT03071133
- Sponsor's protocol ID
- AI443-144
- Status last verified
- Feb 2022
- First submitted
- 1 Mar 2017
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asunaprevir/Daclatasvir/Beclabuvir Fixed-Dose Combination Safety Surveillance in Japanese Patients With Chronic Hepatitis C (HCV) or Japanese Patients With Compensated Cirrhosis
- ClinicalTrials.gov ID
- NCT03071133
- Acronym / sponsor ID
- AI443-144
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 8 Jan 2019 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 6 Mar 2017 (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.
An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in Japan who are initiating treatment with DCV Trio therapy
Key inclusion criteria (1 listed)
- Patients who are initiating the treatment with DCV Trio therapy under the approved indications, dosage, and administration
Key exclusion criteria (1 listed)
- Patients who use the DCV Trio off label
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
Incidence of Aspartate Aminotransferase (AST) elevation
Time frame: Up to 36 weeks
measured by immunoassay
Incidence of Alanine Aminotransferase (ALT) elevation
Time frame: Up to 36 weeks
measured by immunoassay
Incidence of Total Bilirubin (tBili) elevation
Time frame: Up to 36 weeks
measured by immunoassay
4 secondary outcomes
Incidence of adverse drug reactions (ADRs) in HCV patients treated with DCV Trio therapy in Japan
Time frame: Up to 36 weeks
Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12)
Time frame: Up to 24 weeks
Proportion of patients with undetectable HCV RNA at 24 weeks post-treatment (SVR24)
Time frame: Up to 36 weeks
Percentage of patients to experience virologic breakthrough
Time frame: Up 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 23 Feb 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Investigator Inquiry FormLink 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 Japan.
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 1 inclusion and 1 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 23 Feb 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 Japan. 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?
Incidence of Aspartate Aminotransferase (AST) elevation (time frame: Up to 36 weeks). The study lists 3 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 23 Feb 2022.