Evaluation of the Safety of Relaxin in Preeclampsia

Condition(s) targeted: Pre-Eclampsia

Intervention: recombinant human relaxin (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Corthera, Inc.

Official(s) and/or principal investigator(s):
Sam Teichman, MD, Study Director, Affiliation: Corthera, Inc.

Overall contact:
Sam Teichman, MD, Phone: (925) 314-0569

The purpose of this study is to determine whether different doses of recombinant human relaxin is safe when given to women with severe preeclampsia

Official title: A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety of Recombinant Human Relaxin (rhRlx) in Subjects With Preeclampsia

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study

Primary outcome:

maternal adverse experiences

fetal adverse experiences

neonatal adverse experiences

Secondary outcome:

preeclampsia assessments

vital signs

physical examinations

clinical laboratory assessments

Detailed description: The effects of relaxin may be beneficial in the treatment of women with preeclampsia. This study will preliminarily evaluate the maternal, fetal and neonatal safety and tolerability of an IV infusion of relaxin compared with placebo given to women with severe preeclampsia.

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Diagnosis of preeclampsia

- Hospital admission for expectant management

Exclusion Criteria:

- Eclampsia or history of seizures

- Vaginal bleeding

- Multifetal gestation

- Requirement for immediate delivery

Sam Teichman, MD, Phone: (925) 314-0569

Central Baptist Hospital, Lexington, Kentucky 40503, United States; Recruiting
John R Barton, MD, Phone: 859-260-6970

University of Cincinnati, Cincinnati, Ohio 45267, United States; Recruiting
Helen How, MD, Phone: 513-584-7242

Starting date: October 2006
Last updated: April 7, 2008