Trials / Completed
CompletedNCT01704001
Clinical Pharmacokinetics Study of ART-123 in Disseminated Intravascular Coagulation (DIC) Subjects With Renal Impairment
A Post-Marketing Clinical Pharmacokinetics Study of ART-123 in DIC Subjects With Renal Impairment
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Asahi Kasei Therapeutics Corporation · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ART-123 | 380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2013-10-01
- Completion
- 2014-06-01
- First posted
- 2012-10-11
- Last updated
- 2017-02-15
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT01704001. Inclusion in this directory is not an endorsement.