A Phase 2 interventional study of Anti-digoxin antibody (FAB fragment) and sodium chloride in Pre-eclampsia, sponsored by BTG International Inc.. Completed at 8 sites in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2014-08-08.
Sponsored by BTG International Inc. · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether a commercially available anti-digoxin antibody, Digibind, can delay delivery in patients with severe pre-eclampsia. If so, this would allow more time for maternally administered steroids to prevent the development of respiratory complications in premature infants.
Preeclampsia (PE) is a serious complication of third trimester pregnancy manifested by high blood pressure, proteinuria, edema, encephalopathy sometimes with seizures, and hepatic failure. There is no known specific treatment, although palliative measures such as antihypertensive drugs, magnesium, steroids and early delivery improve outcomes. Multiple abnormalities have been demonstrated in PE but the relation of these abnormalities to the cause, pathophysiology and treatment is unknown. One of these abnormalities is elevation in the circulating level of a "digoxin-like" factor (EDLF), an unknown substance that cross reacts with digoxin antibodies and inhibits Na,K ATPase. An extensive literature supports the hypothesis that increased levels of EDLF may be a causative factor in the pathogenesis of hypertension. Increased levels of this factor are found both in maternal and fetal blood, both in normal pregnancy, and in pregnancy complicated by PE. Levels of this factor are higher in PE than in normal pregnancy suggesting it might play a role in the pathophysiology of PE.
Digibind (Glaxo Smith Kline) is a commercially available FAB fragment, antidigoxin antibody approved for the treatment of digoxin intoxication. In experimental models of hypertension with elevated EDLF levels, Digibind has been shown to lower blood pressure, suggesting that the antibody cross reacts with EDLF. These observations have led to the hypothesis that Digibind might ameliorate some of the manifestations of PE, especially the hypertension. Based on an extensive pre-clinical literature supporting that hypothesis, and encouraging results in 8 cases, a clinical trial is planned to test the effect of Digibind in severe PE. The study is a multi- site, parallel, double blind, placebo controlled, randomized trial. After randomization, 50 patients will be given the usual treatment for severe PE, plus study drug (Digibind or placebo) every six hours, for 48 hours. The study may be terminated during the treatment period for standard indications for early delivery.
Data collection will include: delivery latency, maternal blood pressure, antihypertensive use, renal function, hepatic function, CBC and platelet count, and umbilical artery blood flow by color doppler. Standard maternal and fetal monitoring will be followed. Newborn assessment will include: status at birth, APGAR score, NICU length of stay, respirator use and duration, and any medical complications. Adverse events will be recorded.
882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.
This study's enrollment of 51 is below the median of 110 across 468 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →BTG International Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.
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A subject with a diagnosis of severe preeclampsia will be eligible for inclusion if she meets the following criteria:
Meets both American College of Obstetricians (ACOG) criteria for preeclampsia (modified to limit selection to patients with the required severity)
Meets at least one of the following ACOG criteria for severe preeclampsia (modified to limit selection to patients with the required severity)
. Proteinuria of 5 grams or higher in a 24-hour specimen or 3+ or greater on 2 random urine samples collected at least 4 hours apart
Exclusion Criteria:
Digibind treatment plus standard of care
Drug: Anti-digoxin antibody (FAB fragment)
Other: sodium chloride
intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours.
Also known as: Digibind
Change in Creatinine Clearance
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.
| Milestone | Digoxin Immune Fab | Placebo |
|---|---|---|
| Started | 24 | 27 |
| Completed | 15 | 20 |
| Not completed | 9 | 7 |
change from baseline in creatinine clearance measured at 24 to 48 hours, comparing patients who received placebo with those who received digoxin immune fab
| milliliters/minute | Digoxin Immune Fab | Placebo |
|---|---|---|
| Change in Creatinine Clearance | -8 ± 43 | -22 ± 56 |
Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Digoxin Immune Fab | — | 0/24 (0%) | 1/24 (4.2%) |
| Placebo | — | 1/27 (3.7%) | 1/27 (3.7%) |
| Event | Digoxin Immune Fab | Placebo |
|---|---|---|
| Depressed level of consciousnessNervous system disorders | 0/24 | 1/27 |
| Event | Digoxin Immune Fab | Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 1/24 | 1/27 |
| vomitingGastrointestinal disorders | 1/24 | 1/27 |
| hypothermiaGeneral disorders | 0/24 | 1/27 |
| urinary tract infectionInfections and infestations | 0/24 | 1/27 |
| uterine atonyReproductive system and breast disorders | 0/24 | 1/27 |
| Age, Continuous(years) | Digoxin Immune Fab | Placebo | Total |
|---|---|---|---|
| Mean | 26 ± 7.1 | 26 ± 6.2 | 26 ± 6.6 |
| Sex: Female, Male(Participants) | Digoxin Immune Fab | Placebo | Total |
|---|---|---|---|
| Female | 24 | 27 | 51 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Digoxin Immune Fab | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 7 | 12 | 19 |
| White | 10 | 7 | 17 |
| More than one race | 7 | 8 | 15 |
| Unknown or Not Reported | 0 | 0 | 0 |
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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BTG International Inc.