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”

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

Study Type: Interventional

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

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.

Intervention(s) in this Clinical Trial

• Drug: recombinant human relaxin

Primary Measures

• maternal adverse experiences
• fetal adverse experiences
• neonatal adverse experiences

Secondary Measures

• preeclampsia assessments
• vital signs
• physical examinations
• clinical laboratory assessments

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Corthera, Inc.

Overall Clinical Trial Officials and Contacts

Sam Teichman, MD Study Director Corthera, Inc.  

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

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00333307

Study ID Number: RLX.PE.001

ClinicalTrials.gov Identifier: NCT00333307

Health Authority: United States: Food and Drug Administration