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Trial record 25 of 120 for:    severe preeclampsia AND delivery

Efficacy Study of Digibind for Treatment of Severe Preeclampsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00158743
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : August 8, 2014
Last Update Posted : August 8, 2014
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
BTG International Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pre-eclampsia
Interventions Drug: Anti-digoxin antibody (FAB fragment)
Other: sodium chloride
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Digoxin Immune Fab Placebo
Hide Arm/Group Description

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.

sodium chloride placebo
Period Title: Overall Study
Started 24 27
Completed 15 20
Not Completed 9 7
Arm/Group Title Digoxin Immune Fab Placebo Total
Hide Arm/Group Description

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.

sodium chloride placebo Total of all reporting groups
Overall Number of Baseline Participants 24 27 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 27 participants 51 participants
26  (7.1) 26  (6.2) 26  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 27 participants 51 participants
Female
24
 100.0%
27
 100.0%
51
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 27 participants 51 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  29.2%
12
  44.4%
19
  37.3%
White
10
  41.7%
7
  25.9%
17
  33.3%
More than one race
7
  29.2%
8
  29.6%
15
  29.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change in Creatinine Clearance
Hide Description change from baseline in creatinine clearance measured at 24 to 48 hours, comparing patients who received placebo with those who received digoxin immune fab
Time Frame Baseline to 24-48 hours.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Digoxin Immune Fab Placebo
Hide Arm/Group Description:

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.

sodium chloride placebo
Overall Number of Participants Analyzed 15 20
Mean (Standard Deviation)
Unit of Measure: milliliters/minute
-8  (43) -22  (56)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Digoxin Immune Fab Placebo
Hide Arm/Group Description

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.

sodium chloride placebo
All-Cause Mortality
Digoxin Immune Fab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Digoxin Immune Fab Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      1/27 (3.70%)    
Nervous system disorders     
Depressed level of consciousness   0/24 (0.00%)  0 1/27 (3.70%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Digoxin Immune Fab Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/24 (4.17%)      1/27 (3.70%)    
Gastrointestinal disorders     
Nausea   1/24 (4.17%)  1 1/27 (3.70%)  1
vomiting   1/24 (4.17%)  1 1/27 (3.70%)  1
General disorders     
hypothermia   0/24 (0.00%)  0 1/27 (3.70%)  1
Infections and infestations     
urinary tract infection   0/24 (0.00%)  0 1/27 (3.70%)  1
Reproductive system and breast disorders     
uterine atony   0/24 (0.00%)  0 1/27 (3.70%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Suzanne Ward Pharm D
Organization: BTG International Inc
Phone: 610-278-1660
EMail: suzanne.ward@btgplc.com
Publications:
Layout table for additonal information
Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT00158743     History of Changes
Other Study ID Numbers: DEEP
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: July 17, 2014
Results First Posted: August 8, 2014
Last Update Posted: August 8, 2014