Hepatocellular CarcinomaNCT02269995
Post-marketing Surveillance of DC Bead in Patients With Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Eisai Co., Ltd. at 1 site in Japan.
Trial summary
This surveillance's objectives are: 1. Unknown adverse reactions 2. Incidences of adverse drug reaction 3. Factors considered to have effect to safety and effectiveness Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- E7040
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteJapan
- Study dates
- 6 Mar 2014to 25 Dec 2015
- 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 with Hepatocellular carcinoma
Who may be able to join
- Patients with Hepatocellular carcinoma
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
This surveillance's objectives are:
- Unknown adverse reactions
- Incidences of adverse drug reaction
- Factors considered to have effect to safety and effectiveness
- Conditions
- Hepatocellular Carcinoma
- Being tested
- E7040
- Keywords
- Hepatocellular, Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E7040Device
Also called DC Beads
E7040 of optimal particle size (-300 um, 300-500 um, or 500-700 um to fit in a target vessel, target lesion, or embolized area) as transcatheter study device will be administered .
| Study group | Role | What they receive |
|---|---|---|
| E7040 | Not described Receives: Device: E7040 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability as measured by Adverse Events
Measured: Up to 30 days
Secondary outcomes (1)
Efficacy of DC bead as assessed by embolic performance
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study start6 Mar 2014
- Primary completion14 May 2015
- Study completion25 Dec 2015
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 Hepatocellular CarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269995
- Sponsor's protocol ID
- DCB01S
- Status last verified
- Jan 2017
- First submitted
- 22 Aug 2014
- Last updated
- 5 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Jpn J Intervent Radiol. 2017;32:136-141.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance of DC Bead in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02269995
- Acronym / sponsor ID
- DCB01S
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular, Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2014 (actual)
- Primary completion
- 14 May 2015 (actual)
- Study completion
- 25 Dec 2015 (actual)
- First posted
- 21 Oct 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.
This surveillance's objectives are:
- Unknown adverse reactions
- Incidences of adverse drug reaction
- Factors considered to have effect to safety and effectiveness
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E7040 | – | Device: E7040 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Hepatocellular carcinoma
Key inclusion criteria (1 listed)
- Patients with Hepatocellular carcinoma
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| E7040Also: DC BeadsE7040 of optimal particle size (-300 um, 300-500 um, or 500-700 um to fit in a target vessel, target lesion, or embolized area) as transcatheter study device will be administered . | Device | E7040 |
Primary outcome
Safety and Tolerability as measured by Adverse Events
Time frame: Up to 30 days
1 secondary outcome
Efficacy of DC bead as assessed by embolic performance
Time frame: Up to 30 days
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 5 Nov 2018.
- BackgroundJpn J Intervent Radiol. 2017;32:136-141.
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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?
An observational study of Hepatocellular Carcinoma, run by Eisai Co., Ltd. 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 5 Nov 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 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?
Safety and Tolerability as measured by Adverse Events (time frame: Up to 30 days). 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 NCT02269995, 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 5 Nov 2018.