Safety and Efficacy of RLX030 in Pregnant Women With Pre- Eclampsia
Condition: Pre-eclampsia
MeSH terms: Eclampsia; Pre-Eclampsia
Intervention: Placebo; RLX030
Intervention description: Placebo to RLX030 as intravenous infusion for 72 hours; RLX030 1 mg/mL vials
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: human recombinant RLX030; Pre-eclampsia; hemodynamics; Pharmacokinetics

Summary:

      This study is designed in two parts. Part 1 will assess the safety and tolerability of
      different doses of RLX030 when given to pregnant women with pre- eclampsia (elevated blood
      pressure with protein in urine). Part 2 will assess whether an optimal dose of RLX030 can
      prolong pregnancy in women with pre-eclampsia.
    

Eligibility criteria:

        Key Inclusion criteria:

          -  Written informed consent was obtained before any assessment was performed.

          -  Women at 18 to 40 years of age with a pregnancy 28 weeks (0 days) and 33 weeks (+4
             days) gestational age. Gestational age was based on mother's last menstruation; if
             last menstruation was unknown, an alternative method was used as applicable and was
             documented in the (electronic) Case Report/Record Form [(e)CRF].

          -  Women with a diagnosis of pre-eclampsia or superimposed pre-eclampsia requiring
             hospitalization. Pre-eclampsia was defined as new onset of hypertension (SBP ≥ 140 or
             DBP ≥ 90 mmHg) or gestational hypertension accompanied by proteinuria (>= 0.3 g/24h)
             after 20 weeks of gestation. Superimposed pre-eclampsia was defined as chronic
             hypertension with new onset of proteinuria after 20 weeks of gestation.

          -  Reassuring fetal testing (cardiotocography and biophysical profile)

        Key Exclusion criteria:

          -  Severe hypertension (SBP ≥ 160 mmHg or DBP ≥ 110 mmHg) and /or those receiving
             anti-hypertensive treatment at time of randomization.

          -  Clinically relevant electrocardiogram (ECG) abnormalities at screening excluding those
             abnormalities commonly seen in pregnancy according to the Investigator.

          -  Symptoms indicative of severe pre-eclampsia or HELLP syndrome (Hemolysis, Elevated
             Liver enzymes, and Low Platelet count) for which immediate delivery of the baby may be
             indicated. Symptoms include persistent CNS symptoms (severe headaches, visual changes,
             altered mentation), persistent right upper quadrant or epigastric pain, nausea or
             vomiting, severe thrombocytopenia (<100,000/mm3) and abnormal (> 2X upper limit of
             normal) liver enzymes (alanine aminotransferase [ALT] or aspartate aminotransferase
             [AST]).

          -  Eclampsia during current pregnancy, vaginal bleeding present at screening, abruptio
             placentae, oligohydramnios

          -  Current diagnosis of a seizure disorder that requires chronic medication.

          -  Pre-gestational diabetes (Type 1 or Type 2) with or without diabetic retinopathy.
             Diagnosis (previous or current) of gestational diabetes, regardless of treatment, was
             allowed

          -  Known allergy to magnesium sulfate or steroids.

          -  Multifetal gestation, known major fetal anomaly, intrauterine growth restriction (<5th
             percentile).