drugset / Trial / NCT00704665
Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma
Phase 3
Completed
231 enrolled
University of Medicine and Dentistry of New Jersey
Boston University · collabGeorgetown University · collabJohns Hopkins University · collabMedical College of Wisconsin · collabMedical University of South Carolina · collabStanford University · collabUConn Health · collabUniversity of California, Los Angeles · collabUniversity of California, San Diego · collabUniversity of Chicago · collabUniversity of Colorado, Denver · collabUniversity of Pittsburgh · collabWayne State University · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Relaxin is a naturally occurring protein prduced by the ovary or placenta in pregnancy. It has ani-fibrotic properties. Previous studies have shown that relaxin is safe at concentrations upto 60 times higher than achieved in pregnancy. Study is designed to see if skin improvement and improvement in functional ability can be achieved.
Timeline
- Start
- 1998-12
- Primary completion
- 2001-12
- Completion
- 2001-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Relaxin | Protein / enzyme biologic | 10 ug/kg | — |
| Comparator | Relaxin | Protein / enzyme biologic | 25 ug/kg | — |