Chronic Hepatitis CNCT02250001
Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C
An observational study of Chronic Hepatitis C, run by Bristol-Myers Squibb at 1 site in Japan.
Trial summary
The primary objective of this study is: To evaluate the real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of DCV/ASV dual therapy in Japanese patients chronically infected with HCV GT-1. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Hepatitis C
- How many people
- 2,974 participants
- Where
- 1 siteJapan
- Study dates
- 30 Sep 2014to 20 Jan 2017
- How long will I take part?
- 48 Weeks
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: University hospitals, General hospitals, and clinics that have relevant departments, such as Liver Internal medicine, Gastroenterological medicine, Internal medicine, etc, where the surveillance drug is mainly prescribed
Who may be able to join
- Patients who are initiating DCV and ASV treatment for the first time under the approved indications, dosage, and administration will be included in this study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is: To evaluate the real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of DCV/ASV dual therapy in Japanese patients chronically infected with HCV GT-1.
Read the detailed description
Time Perspective: Other - For patients who are treated before the contract between Bristol-Myers Kabushiki Kaisha (BMKK) and the treating physician is initiated, patient data will be collected retrospectively after the contract is signed. Data will be collected prospectively for patients who initiate DCV/ASV treatment after the contract is initiated
Patient Registry study - Yes; 48 weeks (Treatment: 24 weeks, Follow up: 24 weeks)
- Conditions
- Chronic Hepatitis C
- Keywords
- HCV
- 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 |
|---|---|---|
| Treatment with DCV/ASV | Patients who are beginning to receive the treatment with DCV/ASV under the approved indications, dosage, and administration will be included in this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of Daclatasvir/Asunaprevir (DCV/ASV) dual therapy in Japanese patients chronically infected with Hepatitis C virus Genotype 1 (HCV GT-1)
Measured: 28 weeks
Secondary outcomes (1)
Antiviral activity as determined by the proportion of patients with sustained virologic response at 24 weeks post-treatment Sustained virologic response at 24 weeks post-treatment (SVR24)
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study start30 Sep 2014
- Primary completion20 Jan 2017
- Study completion20 Jan 2017
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
- Case only
- Time perspective
- Other
- Enrolment
- 2,974 participants (actual)
- Target duration
- 48 Weeks
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
- NCT02250001
- Sponsor's protocol ID
- AI444-244
- Status last verified
- May 2017
- First submitted
- 24 Sep 2014
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT02250001
- Acronym / sponsor ID
- AI444-244
- Conditions
- Chronic Hepatitis C
- Keywords
- HCV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,974 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2014 (actual)
- Primary completion
- 20 Jan 2017 (actual)
- Study completion
- 20 Jan 2017 (actual)
- First posted
- 26 Sep 2014 (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 evaluate the real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of DCV/ASV dual therapy in Japanese patients chronically infected with HCV GT-1.
Detailed description
Time Perspective: Other - For patients who are treated before the contract between Bristol-Myers Kabushiki Kaisha (BMKK) and the treating physician is initiated, patient data will be collected retrospectively after the contract is signed. Data will be collected prospectively for patients who initiate DCV/ASV treatment after the contract is initiated
Patient Registry study - Yes; 48 weeks (Treatment: 24 weeks, Follow up: 24 weeks)
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 48 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with DCV/ASV | – | –Patients who are beginning to receive the treatment with DCV/ASV under the approved indications, dosage, and administration will be included in this study |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University hospitals, General hospitals, and clinics that have relevant departments, such as Liver Internal medicine, Gastroenterological medicine, Internal medicine, etc, where the surveillance drug is mainly prescribed
Key inclusion criteria (1 listed)
- Patients who are initiating DCV and ASV treatment for the first time under the approved indications, dosage, and administration will be included in this study
Key exclusion criteria (0 listed)
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
The real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of Daclatasvir/Asunaprevir (DCV/ASV) dual therapy in Japanese patients chronically infected with Hepatitis C virus Genotype 1 (HCV GT-1)
Time frame: 28 weeks
1 secondary outcome
Antiviral activity as determined by the proportion of patients with sustained virologic response at 24 weeks post-treatment Sustained virologic response at 24 weeks post-treatment (SVR24)
Time frame: 48 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 3 May 2017.
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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 Chronic 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 0 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 3 May 2017. 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?
The real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of Daclatasvir/Asunaprevir (DCV/ASV) dual therapy in Japanese patients chronically infected with Hepatitis C virus Genotype 1 (HCV GT-1) (time frame: 28 weeks). 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 3 May 2017.