Relaxin a 6000 MW protein is normally secreted by corpus luteum and placenta throughout pregnancy. It's biologic effects include remodeling of connective tissue. Recombinant relaxin is of theoretical benefit in scleroderma, a disease characterized by thickening and fibrosis of the skin and distinctive fibrosis of internal organs, including the lungs, kidneys and gastrointestinal tract. Currently there is no known therapy for scleroderma. A phase I trial of continuous subcutaneous relaxin in 30 patients with scleroderma showed no serious adverse effects or clinically significant drug-related laboratory abnormalities. This study will be randomized, double blind, phase II trial of safety and efficacy of subcutaneous continuous infusion of recombinant, human relaxin for 24 weeks at two different dose levels, versus placebo in patients with diffuse scleroderma. Safety evaluation will include vital signs, urinalyses, hematology, chemistry and coagulation profiles, and recording of adverse events.

Project Start
Project End
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
31
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Boston University
Department
Type
DUNS #
604483045
City
Boston
State
MA
Country
United States
Zip Code
02118
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