Trial Outcomes & Findings for Safety and Efficacy of RLX030 in Pregnant Women With Pre- Eclampsia (NCT NCT01566630)

NCT ID: NCT01566630

Last Updated: 2015-11-05

Results Overview

Safety and tolerability was assessed by adverse events/serious adverse event and death monitoring.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 3 participants
• Primary outcome timeframe: Prior to delivery until 4-6 weeks post partum (maximum of 8 weeks)
• Results posted on: 2015-11-05

Participant Flow

Participant milestones

Measure	RLX030 Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. As per planned treatment assigned, patients in this arm received open label serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours.	Placebo Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. The randomized patient received matching placebo of serelaxin (RLX030) in a blinded manner.
Overall Study STARTED	2	1
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	RLX030 n=2 Participants Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. As per planned treatment assigned, patients in this arm received open label serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours.	Placebo n=1 Participants Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. The randomized patient received matching placebo of serelaxin (RLX030) in a blinded manner.	Total n=3 Participants Total of all reporting groups
Age, Customized Between age 18 to 40 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Prior to delivery until 4-6 weeks post partum (maximum of 8 weeks)

Population: No formal analysis was performed as the study was terminated after three patients were enrolled and dosed.

Safety and tolerability was assessed by adverse events/serious adverse event and death monitoring.

Outcome measures

Measure	RLX030 - Maternal n=2 Participants Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia	Placebo - Maternal n=1 Participants Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia	RLX030- Neonates Born to Patients n=2 Participants Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received	Placebo- Neonates Born to Patients n=1 Participants Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study Serious Adverse events	2 Participants	1 Participants	2 Participants	1 Participants
Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study Death	0 Participants	0 Participants	0 Participants	0 Participants
Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study Non-serious AEs	2 Participants	1 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 (maximum of 8 weeks)

Population: No formal analysis was performed as the study was terminated after three patients were enrolled and dosed

Maternal safety assessment to monitor pre-eclampsia by checking blood pressure during 72 hour treatment period as well as post-dose.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 (maximum of 8 weeks)

Population: No formal analysis was performed as the study was terminated after three patients were enrolled and dosed

Maternal safety assessment to monitor pre-eclampsia by checking mean arterial pressure during 72 hour treatment period as well as post-dose.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 (maximum of 8 weeks)

Population: No formal analysis was performed as the study was terminated after three patients were enrolled and dosed

Pre-eclampsia was monitored by checking levels of protein in urine and by urinary protein/creatinine ratio (UPCR)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: During treatment period of a maximum 72 hours infusion prior to delivery and up to delivery in part 1 (maximum of 3 weeks)

Population: No formal analysis was performed as the study was terminated after three patients were enrolled and dosed

Blood flow to the fetus was monitored using via a Doppler.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: During treatment period of a maximum 72 hours infusion prior to delivery and up to delivery in part 1 (maximum of 3 weeks)

Population: No formal analysis was performed as the study was terminated after three patients were enrolled and dosed

Heart rate of fetus was monitored continuously throughout 72 hour treatment period using a cardiotocograph.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From randomization until 4-6 weeks post partum (maximum 8 weeks)

Population: No formal analysis was performed as the study was terminated after three patients were enrolled and dosed

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From randomization to delivery (maximum of 3 weeks)

Population: No formal analysis was performed as the study was terminated after three patients were enrolled and dosed

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From Randomization until 4-6 weeks post partum (maximum of 8 weeks)

Population: No formal analysis was performed as the study was terminated after three patients were enrolled and dosed

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: up to 4 - 6 weeks post partum (maximum of 8 weeks )

Population: No formal analysis was performed as the study was terminated after three patients were enrolled and dosed

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Randomization to delivery (maximum of 3 weeks)

Population: No formal analysis was performed as the study was terminated after three patients were enrolled and dosed

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1

Population: No formal analysis was performed as the study was terminated after three patients were enrolled and dosed

Blood concentrations of RLX-030 was assayed to determine this PK parameter.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1

Population: No formal analysis was performed as the study was terminated after three patients were enrolled and dosed

Blood concentrations of RLX-030 was assayed to determine this PK parameter.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1

Population: No formal analysis was performed as the study was terminated after three patients were enrolled and dosed

Blood concentrations of RLX-030 was assayed to determine this PK parameter.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1

Population: No formal analysis was performed as the study was terminated after three patients were enrolled and dosed

Blood concentrations of RLX-030 was assayed to determine this PK parameter.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1

Population: No formal analysis was performed as the study was terminated after three patients were enrolled and dosed

Blood concentrations of RLX-030 was assayed to determine this PK parameter.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization until delivery (maximum of 3 weeks)

Population: No formal analysis was performed as the study was terminated after three patients were enrolled and dosed

Outcome measures

Outcome data not reported

Adverse Events

RLX030- Maternal

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

RLX030- Neonates Born to Patients

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo- Maternal

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo- Neonates Born to Patients

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	RLX030- Maternal n=2 participants at risk Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia	RLX030- Neonates Born to Patients n=2 participants at risk Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received	Placebo- Maternal n=1 participants at risk Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia	Placebo- Neonates Born to Patients n=1 participants at risk Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	100.0% 1/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
Pregnancy, puerperium and perinatal conditions Premature baby	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	100.0% 2/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	100.0% 1/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
Pregnancy, puerperium and perinatal conditions Premature delivery	100.0% 2/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	100.0% 1/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
Surgical and medical procedures Caesarean section	50.0% 1/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	100.0% 1/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
Vascular disorders Hypertension	50.0% 1/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.

Other adverse events

Measure	RLX030- Maternal n=2 participants at risk Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia	RLX030- Neonates Born to Patients n=2 participants at risk Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received	Placebo- Maternal n=1 participants at risk Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia	Placebo- Neonates Born to Patients n=1 participants at risk Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	50.0% 1/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
Gastrointestinal disorders Constipation	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	100.0% 1/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
Gastrointestinal disorders Nausea	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	100.0% 1/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
Gastrointestinal disorders Vomiting	50.0% 1/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	100.0% 1/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
General disorders Chest pain	50.0% 1/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
Hepatobiliary disorders Jaundice	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	50.0% 1/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
Investigations Alanine aminotransferase increased	50.0% 1/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
Investigations Aspartate aminotransferase increased	50.0% 1/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
Investigations Blood creatinine increased	50.0% 1/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
Investigations Platelet count decreased	50.0% 1/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
Metabolism and nutrition disorders Hypoalbuminaemia	50.0% 1/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
Metabolism and nutrition disorders Hypoglycaemia	50.0% 1/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
Nervous system disorders Headache	50.0% 1/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	50.0% 1/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	50.0% 1/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
Respiratory, thoracic and mediastinal disorders Dyspnoea	50.0% 1/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
Respiratory, thoracic and mediastinal disorders Epistaxis	50.0% 1/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
Respiratory, thoracic and mediastinal disorders Transient tachypnoea of the newborn	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	50.0% 1/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	100.0% 1/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.
Surgical and medical procedures Mechanical ventilation	0.00% 0/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	50.0% 1/2 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.	0.00% 0/1 The safety evaluation population included all patients who commenced study drug infusion. Safety reportied on all patients and their neonates.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: trialandresults.registries@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
• Publication restrictions are in place

Restriction type: OTHER