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...
Brief 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.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Primary Purpose: Treatment
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: relaxin
Criteria for Participation in this Clinical Trial
PROTOCOL ENTRY CRITERIA:
- -Disease Characteristics--
- Progressive systemic sclerosis (scleroderma)
- No pregnant or nursing women
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: National Center for Research Resources (NCRR) NIH
Overall Clinical Trial Officials and Contacts
G. Scott Herron Study Chair Stanford University
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00004380
Study ID Number: 199/12015
ClinicalTrials.gov Identifier: NCT00004380
Health Authority: United States: Federal Government
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00004380
