Trial Outcomes & Findings for Efficacy Study of Digibind for Treatment of Severe Preeclampsia (NCT NCT00158743)
NCT ID: NCT00158743
Last Updated: 2014-08-08
Results Overview
change from baseline in creatinine clearance measured at 24 to 48 hours, comparing patients who received placebo with those who received digoxin immune fab
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
Baseline to 24-48 hours.
Results posted on
2014-08-08
Participant Flow
Participant milestones
| Measure |
Digoxin Immune Fab
Digibind treatment plus standard of care
Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours.
|
Placebo
sodium chloride placebo
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
27
|
|
Overall Study
COMPLETED
|
15
|
20
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy Study of Digibind for Treatment of Severe Preeclampsia
Baseline characteristics by cohort
| Measure |
Digoxin Immune Fab
n=24 Participants
Digibind treatment plus standard of care
Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours.
|
Placebo
n=27 Participants
sodium chloride placebo
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
26 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
26 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 24-48 hours.change from baseline in creatinine clearance measured at 24 to 48 hours, comparing patients who received placebo with those who received digoxin immune fab
Outcome measures
| Measure |
Digoxin Immune Fab
n=15 Participants
Digibind treatment plus standard of care
Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours.
|
Placebo
n=20 Participants
sodium chloride placebo
|
|---|---|---|
|
Change in Creatinine Clearance
|
-8 milliliters/minute
Standard Deviation 43
|
-22 milliliters/minute
Standard Deviation 56
|
Adverse Events
Digoxin Immune Fab
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Digoxin Immune Fab
n=24 participants at risk
Digibind treatment plus standard of care
Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours.
|
Placebo
n=27 participants at risk
sodium chloride placebo
|
|---|---|---|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
Other adverse events
| Measure |
Digoxin Immune Fab
n=24 participants at risk
Digibind treatment plus standard of care
Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours.
|
Placebo
n=27 participants at risk
sodium chloride placebo
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.2%
1/24 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Gastrointestinal disorders
vomiting
|
4.2%
1/24 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
General disorders
hypothermia
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Reproductive system and breast disorders
uterine atony
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place