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...
Date First Received: October 18, 1999
Last Updated: June 23, 2005
Verified by: Office of Rare Diseases (ORD), July 2004
Clinical Trial Phase: Phase 2 | Start Date: December 1991
Overall Status: Completed
Estimated Enrollment: 1
Brief Summary
Condition Keyword(s):
Intervention(s):
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: Treatment, Non-Randomized
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.
Criteria for Participation in this Clinical Trial
PROTOCOL ENTRY CRITERIA:
- -Disease Characteristics--
- Progressive systemic sclerosis (scleroderma)
- No pregnant or nursing women
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: National Center for Research Resources (NCRR)
Overall Clinical Trial Officials and Contacts
G. Scott Herron Study Chair Stanford University
Additional Information
Information obtained from ClinicalTrials.gov on July 23, 2008
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
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
