| Trial ID: | L0963 |
| Source ID: | NCT01227187
|
| Associated Drug: |
Drotrecogin Alfa Activated (Xigris)
|
| Title: |
Safety and Dose Finding Study of Xigris in Hemodialysis Patients
|
| Acronym: |
Xigris1003
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01227187/results
|
| Conditions: |
End Stage Renal Disease
|
| Interventions: |
DRUG: Drotrecogin alfa activated (Xigris)
|
| Outcome Measures: |
Primary: Mean Partial Thromboplastin Time (PTT) at 15 Minutes, PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant., PTT level at 15 minutes after start up of Xigris during the hemodialysis treatment.|Mean Partial Thromboplastin Time (PTT) at 30 Minutes, PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant., PTT level at 30 minutes after start up of Xigris during the hemodialysis treatment.|Mean Partial Thromboplastin Time (PTT) at 60 Minutes, PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant., PTT level at 60 minutes after start up of Xigris during the hemodialysis treatment.|Mean Partial Thromboplastin Time (PTT) at 120 Minutes, PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant., PTT level at 120 minutes after start up of Xigris during the hemodialysis treatment.|Mean Partial Thromboplastin Time (PTT) at 180 Minutes, PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant., PTT level at 180 minutes after start up of Xigris during the hemodialysis treatment. |
|
| Sponsor/Collaborators: |
Sponsor: George Washington University | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
12
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2008-10
|
| Completion Date: |
2010-12
|
| Results First Posted: |
2022-02-03
|
| Last Update Posted: |
2022-02-03
|
| Locations: |
The George Washington University Hospital, Washington, District of Columbia, 20037, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01227187
|
