Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis
Information source: Office of Rare Diseases (ORD)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Systemic Sclerosis
Intervention: relaxin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Center for Research Resources (NCRR) Official(s) and/or principal investigator(s):
G. Scott Herron, Study Chair, Affiliation: Stanford University
Summary
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.
Clinical Details
Study design: Treatment, Non-Randomized
Detailed description:
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
PROTOCOL ENTRY CRITERIA:
- -Disease Characteristics--
- Progressive systemic sclerosis (scleroderma)
- No pregnant or nursing women
Locations and Contacts
Additional Information
Starting date: December 1991
Ending date: December 1997
Last updated: June 23, 2005
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