Safety and Efficacy of RLX030 in Pregnant Women With Pre- Eclampsia

NCT ID: NCT01566630

Last Updated: 2015-11-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-08-31

Brief 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.

Conditions

Pre-eclampsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

RLX030

In part 1, within each cohort, two (2) patients per cohort will be treated open label with RLX030 and two (2) patients will be treated double blind with RLX030 as intravenous infusion for 72 hours. There will be 3 cohorts in part 1 with different doses of RLX030.

In part 2, there is no open label treatment on RLX030. In part 2, patients will be randomized in a double-blind fashion to this arm with the optimal dose of RLX030 as intravenous infusion for 72 hours as determined from part 1.

Group Type: EXPERIMENTAL

RLX030

Intervention Type: DRUG

RLX030 1 mg/mL vials

Placebo

In part 1, equal number of subjects will be treated with matching placebo of RLX030 as intravenous infusion for 72 hours in 3 cohorts.

In part 2, patients will be treated with matching placebo of RLX030 as intravenous infusion for 72 hours

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to RLX030 as intravenous infusion for 72 hours

Interventions

Placebo

Placebo to RLX030 as intravenous infusion for 72 hours

Intervention Type: DRUG

RLX030

RLX030 1 mg/mL vials

Intervention Type: DRUG

Eligibility Criteria

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)

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Mobile, Alabama, United States

Novartis Investigative Site

Lexington, Kentucky, United States

Novartis Investigative Site

Louisville, Kentucky, United States

Novartis Investigative Site

Galveston, Texas, United States

Novartis Investigative Site

Modena, MO, Italy

Countries

United States; Italy

Other Identifiers

2011-001617-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CRLX030A2205

Identifier Type: -

Identifier Source: org_study_id