Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis
OBJECTIVES: I. Determine whether parenteral relaxin improves skin tightness, Raynaud's phenomenon, digital morbidity, and digital ulcers in a patient with progressive systemic sclerosis (scleroderma).
II. Determine whether relaxin decreases collagen production by fibroblasts in vivo and cultured from skin biopsies.
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Study Start Date:||December 1991|
|Estimated Study Completion Date:||December 1997|
PROTOCOL OUTLINE: This is a compassionate use study. The patient is treated with subcutaneous injections of recombinant relaxin for approximately 12 months. If clinically indicated, therapy may be extended.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004380
|Study Chair:||G. Scott Herron||Stanford University|