Status:
COMPLETED
Efficacy Study of Digibind for Treatment of Severe Preeclampsia
Lead Sponsor:
BTG International Inc.
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Pre-eclampsia
Eligibility:
FEMALE
Phase:
PHASE2
Brief 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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- A subject with a diagnosis of severe preeclampsia will be eligible for inclusion if she meets the following criteria:
- In the opinion of the investigator delivery is considered to be probably required within a 72 hour time period and, therefore, corticosteroid administration is needed.
- Meets both American College of Obstetricians (ACOG) criteria for preeclampsia (modified to limit selection to patients with the required severity)
- A systolic blood pressure of 140 mm Hg or higher or a diastolic blood pressure of 90 mm Hg or higher occurring after 20 weeks of gestation in a woman whose blood pressure has previously been normal;
- Proteinuria, with excretion of 0.3 g or more of protein in a 24-hour urine specimen or a urine dipstick reading of 1+ or more.
- 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
- A systolic blood pressure of 160 mm Hg or higher or a diastolic blood pressure of 110 mm Hg or higher on two occasions six or more hours apart in a pregnant woman who is on bed rest;
- Oliguria, with excretion of less than 500 ml of urine in 24 hours or average of ≤ 25 ml/hour over a 3 hour period;
- Pulmonary edema;
- Impairment of liver function \[AST(SGOT) \> 72 U/L or ALT(SGPT) \> 72 U/L or LDH \> 600 U/L or Total Bilirubin \>1.2 mg/DL)\];
- Visual or cerebral disturbances;
- Decreased platelet count (≥50,000/mm3 and ≤ 100,000/mm3).
- Has a fetal gestational age of 23 5/7 to 34 weeks.
Exclusion
- Is in need of immediate delivery as soon as clinically appropriate
- Eclampsia
- Significant antecedent obstetrical problems which may interfere with study assessments or safe participation in the study
- Evidence of non-reassuring fetal well being
- Evidence of lethal fetal anomaly
- Antecedent hypertension (hypertension secondary to preeclampsia, treated or untreated is allowed)
- Antecedent renal, hepatic, or autoimmune disease
- Medical or psychiatric disorder which is unstable or which might interfere with study assessments or safe participation in the study
- Evidence on medical history/evaluation of use of or need for digitalis-like products currently or in the future
- History of a severe allergic reaction to previous medication, severe asthma, or atopy. (Patients with a history of allergic reactions to antibiotics, papain, chymopapain, or other papaya extracts may be more susceptible to allergic reactions to Digibind®)
- Prior use of antibodies/FAB fragments from sheep (e.g. Digibind®, DigiFab, CroFab)
- Serum creatinine ≥ 1.5 mg/dl
- Platelet count \<50,000/mm3
- Patient intends to breast feed and does not agree to wait for a minimum of seven days after the last Digibind® dose (a breast pump would be used for this seven day period)
- Inability to understand and provide informed consent
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00158743
Start Date
February 1 2004
End Date
December 1 2007
Last Update
August 8 2014
Active Locations (8)
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1
University of South Alabama
Mobile, Alabama, United States, 36604
2
Phoenix Perinatal Associates
Phoenix, Arizona, United States, 85014
3
Winnie Palmer Hospital
Orlando, Florida, United States, 32806
4
Department of Obstetrics and Gynecology, Louisiana State University Health Sciences Center, PO Box 33932, 1501 Kings Highway
Shreveport, Louisiana, United States, 71130