Trial record 4 of 97 for:    Open Studies | "Pre-Eclampsia"

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

This study is currently recruiting participants.
Verified March 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01566630
First received: March 27, 2012
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Pre-eclampsia
Drug: Placebo
Drug: RLX030
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An Adaptive Multicentre, Randomized, Partially Double-blind, Placebo-controlled Study to Assess the Safety, PK and PD/Efficacy of RLX030 in Women With Pre-eclampsia

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of patients with adverse events, serious adverse and death during part 1 of the study [ Time Frame: Prior to delivery until 4-6weeks post partum ] [ Designated as safety issue: Yes ]
    Safety and tolerability will be assessed by adverse events/serious adverse event and death monitoring.

  • Change from baseline in maternal systolic blood pressure (SBP) and diastolic blood pressure (DBP) in part 1of the study (part 1) [ Time Frame: From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 ] [ Designated as safety issue: Yes ]
    Maternal safety assessment to monitor pre-eclampsia by checking blood pressure during 72 hour treatment period as well as post-dose.

  • Change from baseline in mean maternal arterial pressure (part 1) [ Time Frame: From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 ] [ Designated as safety issue: Yes ]
    Maternal safety assessment to monitor pre-eclampsia by checking mean arterial pressure during 72 hour treatment period as well as post-dose.

  • Change from baseline on maternal proteinuria (Part 1) [ Time Frame: From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 ] [ Designated as safety issue: Yes ]
    Pre-eclampsia will also be monitored by checking levels of protein in urine and by urinary protein/creatinine ratio (UPCR)

  • Decrease in utero-placental blood flow (Part 1) [ Time Frame: During treatment period of a maximum 72 hours infusion prior to delivery and during delivery in part 1 ] [ Designated as safety issue: Yes ]
    Blood flow to the fetus will be monitored using via a Doppler.

  • Change in fetal heart rate (Part 1) [ Time Frame: during treatment period of a maximum 72 hours infusion prior to delivery and during delivery in part 1 ] [ Designated as safety issue: Yes ]
    Heart rate of fetus will be monitored continuously throughout 72 hour treatment period using a cardiotocographer.

  • Pharmacokinetics of RLX030: area under the blood concentration-time curve from time zero to infinity (AUCinf)-Part 1 [ Time Frame: Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 ] [ Designated as safety issue: No ]
    blood concentrations of RLX-030 will be assayed to determine AUCinf (if appropriate)

  • Pharmacokinetics of RLX030: area under the blood concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)-Part 1 [ Time Frame: Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 ] [ Designated as safety issue: No ]
    Blood concentrations of RLX-030 will be assayed to determine AUClast (if appropriate)

  • Pharmacokinetics of RLX030: blood concentration at 24 hour (C 0-24h) after administration- Part 1 [ Time Frame: 24 hours after initiation of infusion during part 1 ] [ Designated as safety issue: No ]
    blood concentrations of RLX-030 will be assayed to determine C 0-24h (if appropriate).

  • Pharmacokinetics of RLX030: terminal elimination half-life (T1/2)- Part 1 [ Time Frame: Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 ] [ Designated as safety issue: No ]
    Blood concentrations of RLX-030 will be obtained.

  • Pharmacokinetics of RLX030: mean residence time (MRT) [ Time Frame: Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1 ] [ Designated as safety issue: No ]
    Blood concentrations of RLX-030 will be assayed to determine MRT (if appropriate)


Estimated Enrollment: 60
Study Start Date: May 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Drug: RLX030
RLX030 1 mg/mL vials
Placebo Comparator: 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

Drug: Placebo
Placebo to RLX030 as intravenous infusion for 72 hours

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Women that are 28- 33 weeks (+4 days) pregnant with a diagnosis of pre- eclampsia or superimposed pre-eclampsia requiring hospitalization
  • Fetus deemed in reasonably good health

Exclusion criteria:

  • Severe hypertension and /or those receiving anti-hypertensive treatment at time of enrollment
  • Severe headaches, visual changes, or altered mentation
  • Upper abdominal pain, nausea, or vomiting
  • Low blood platelet count
  • Diagnosis of a seizure disorder that requires chronic medication
  • Those receiving active anti-coagulation therapy
  • Pre-gestational diabetes (Type 1 or Type 2)
  • Allergy to magnesium sulfate or steroids
  • Known major fetal anomaly
  • Multifetal gestation

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566630

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

Locations
United States, Alabama
Novartis Investigative Site Recruiting
Mobile, Alabama, United States, 36604
United States, Florida
Novartis Investigative Site Withdrawn
Gainesville, Florida, United States, 32610
United States, Kentucky
Novartis Investigative Site Recruiting
Lexington, Kentucky, United States, 40503
Contact: John Barton, MD    859-260-6440    kwillis@bhsi.com   
Novartis Investigative Site Recruiting
Louisville, Kentucky, United States, 40202
Contact: Helen How, MD    502-629-2433    christina.waldon@nortonhealthcare.org   
United States, Mississippi
Novartis Investigative Site Not yet recruiting
Jackson, Mississippi, United States, 39216-4505
United States, South Carolina
Novartis Investigative Site Withdrawn
Charleston, South Carolina, United States, 29425
United States, Texas
Novartis Investigative Site Recruiting
Galveston, Texas, United States, 77555-0587
Contact: Gayle Olson, MD    409-772-1571    esgodbol@utmb.edu   
Novartis Investigative Site Not yet recruiting
Houston, Texas, United States, 77030
Austria
Novartis Investigative Site Not yet recruiting
Wien, Austria, A-1090
Germany
Novartis Investigative Site Not yet recruiting
Berlin, Germany, 13353
Novartis Investigative Site Not yet recruiting
Leipzig, Germany, 04103
Italy
Novartis Investigative Site Not yet recruiting
Bergamo, BG, Italy, 24127
Novartis Investigative Site Recruiting
Brescia, BS, Italy, 25123
Novartis Investigative Site Recruiting
Modena, MO, Italy, 41100
Switzerland
Novartis Investigative Site Not yet recruiting
Bern, Switzerland, CH-3010
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01566630     History of Changes
Other Study ID Numbers: CRLX030A2205, 2011-001617-14
Study First Received: March 27, 2012
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration
France: Ministry of Health
Germany: Ministry of Health
Italy: Ministry of Health
South Africa: Department of Health

Keywords provided by Novartis:
human recombinant RLX030
Pre-eclampsia
hemodynamics
Pharmacokinetics

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on April 20, 2014