CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
Anti-digoxin antibody (FAB fragment) +1 moredrug
Likely dose
Anti-digoxin FAB antibody intravenous dose based on weight (assuming 4 ng/mL EDLF concentration), administered every 6 hours for 48 hoursAI-extracted
Key inclusion· 4
  • ✓Diagnosis of severe preeclampsia meeting ACOG criteria (systolic ≥160 mmHg or diastolic ≥110 mmHg on two occasions ≥6 hours apart, OR proteinuria ≥5 g in 24-hour urine or ≥3+ on two random samples ≥4 hours apart, OR oliguria <500 mL/24 hours or ≤25 mL/hour over 3 hours, OR pulmonary edema, OR liver impairment [AST >72 U/L or ALT >72 U/L or LDH >600 U/L or Total Bilirubin >1.2 mg/dL], OR visual/cerebral disturbances, OR platelets ≥50,000/mm³ and ≤100,000/mm³)
  • ✓Fetal gestational age 23 5/7 to 34 weeks
  • ✓Delivery expected to be required within 72 hours and corticosteroid administration needed, in investigator's opinion
  • ✓Baseline preeclampsia diagnosis: systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg after 20 weeks gestation with previously normal BP, plus proteinuria ≥0.3 g in 24-hour urine or urine dipstick ≥1+
Key exclusion· 11
  • ✕Eclampsia
  • ✕Immediate delivery required
  • ✕Non-reassuring fetal well-being
  • ✕Lethal fetal anomaly

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00158743
NCT00158743Phase 2Completed
CompareCT.gov

A Parallel, Double-blind, Placebo Controlled, Randomized Comparison of an Anti-digoxin Antibody (Digibind) Versus Placebo for the Treatment of Antepartum Patients With Severe Preeclampsia

BTG International Inc.·interventional·Posted Sep 12, 2005·Updated Aug 8, 2014

In Brief

A Phase 2 clinical trial evaluating Anti-digoxin antibody (FAB fragment) and sodium chloride for Pre-eclampsia. Completed, enrolled 51 participants across 8 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPre-eclampsia
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2005
Enrollment StartFeb 1, 2004
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.8 years ago

Interventions

Anti-digoxin antibody (FAB fragment)drug

intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours.

sodium chlorideother