Disseminated Intravascular CoagulationPhase 4NCT01704001
Clinical Pharmacokinetics Study of ART-123 in Disseminated Intravascular Coagulation (DIC) Subjects With Renal Impairment
A Phase 4 study testing ART-123 in people with Disseminated Intravascular Coagulation, run by Asahi Kasei Therapeutics Corporation at 1 site in Japan.
Trial summary
To investigate the impact of impaired renal function on the pharmacokinetics of ART-123 in patients with Disseminated Intravascular Coagulation. To investigate the safety of ART-123 in patients with Disseminated Intravascular Coagulation. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Disseminated Intravascular Coagulation
- What is being tested?
- ART-123
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2012to Jun 2014
- Phase
- Phase 4
- 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
Who may be able to join
- Japanese Association for Acute Medicine-defined DIC criteria score >= 4
- Written informed consent from patient or guardian
Who cannot join
- Patients showing intracranial, pulmonary, gastrointestinal hemorrhage
- Patients with a history of cerebrovascular disorders within the past 52 week
- Patients with a history of hypersensitivity to the ingredients of ART-123 preparations
- Pregnant women, nursing mothers or possibly pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Post-Marketing Clinical Pharmacokinetics Study of ART-123 in DIC Subjects With Renal Impairment
To investigate the impact of impaired renal function on the pharmacokinetics of ART-123 in patients with Disseminated Intravascular Coagulation.
To investigate the safety of ART-123 in patients with Disseminated Intravascular Coagulation.
- Conditions
- Disseminated Intravascular Coagulation
- Being tested
- ART-123
- Keywords
- ART-123, Disseminated Intravascular Coagulation, Pharmacokinetics
- Medical subject headings
- Disseminated Intravascular Coagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ART-123Drug
Also called Recomodulin™
380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days
| Study group | Role | What they receive |
|---|---|---|
| Renal impairment grade 0 | Experimental | Not described Receives: Drug: ART-123 |
| Renal impairment grade 1 | Experimental | Not described Receives: Drug: ART-123 |
| Renal impairment grade 2 | Experimental | Not described Receives: Drug: ART-123 |
| Renal impairment grade 3 | Experimental | Not described Receives: Drug: ART-123 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Pharmacokinetics
Cmax, Area Under Curve, T1/2,CLtot,CLR
Measured: pre-dose, 0,2,4,8,24 hours post-dose
Incidence rate of hemorrhage related adverse events
Measured: from the start of infusion to 8days after the cessation of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disseminated Intravascular CoagulationStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asahi Kasei Therapeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704001
- Sponsor's protocol ID
- ART-123 IV-2
- Status last verified
- Oct 2012
- First submitted
- 1 Oct 2012
- Last updated
- 15 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Marketing Clinical Pharmacokinetics Study of ART-123 in DIC Subjects With Renal Impairment
- ClinicalTrials.gov ID
- NCT01704001
- Acronym / sponsor ID
- ART-123 IV-2
- Conditions
- Disseminated Intravascular Coagulation
- Keywords
- ART-123, Disseminated Intravascular Coagulation, Pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Asahi Kasei Therapeutics CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 11 Oct 2012 (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.
To investigate the impact of impaired renal function on the pharmacokinetics of ART-123 in patients with Disseminated Intravascular Coagulation.
To investigate the safety of ART-123 in patients with Disseminated Intravascular Coagulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Renal impairment grade 0 | Experimental | Drug: ART-123 |
| Renal impairment grade 1 | Experimental | Drug: ART-123 |
| Renal impairment grade 2 | Experimental | Drug: ART-123 |
| Renal impairment grade 3 | Experimental | Drug: ART-123 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Japanese Association for Acute Medicine-defined DIC criteria score >= 4
- Written informed consent from patient or guardian
Key exclusion criteria (4 listed)
- Patients showing intracranial, pulmonary, gastrointestinal hemorrhage
- Patients with a history of cerebrovascular disorders within the past 52 week
- Patients with a history of hypersensitivity to the ingredients of ART-123 preparations
- Pregnant women, nursing mothers or possibly pregnant women
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 |
|---|---|---|
| ART-123Also: Recomodulin™380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days | Drug | Renal impairment grade 0, Renal impairment grade 1, Renal impairment grade 2, Renal impairment grade 3 |
Primary outcome
Composite of Pharmacokinetics
Time frame: pre-dose, 0,2,4,8,24 hours post-dose
Cmax, Area Under Curve, T1/2,CLtot,CLR
Incidence rate of hemorrhage related adverse events
Time frame: from the start of infusion to 8days after the cessation of infusion
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 15 Feb 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.
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?
A Phase 4 study testing ART-123 in people with Disseminated Intravascular Coagulation, run by Asahi Kasei Therapeutics Corporation 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 2 inclusion and 4 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 15 Feb 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Composite of Pharmacokinetics (time frame: pre-dose, 0,2,4,8,24 hours post-dose). 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 15 Feb 2017.