Trials / Completed
CompletedNCT00004380
Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1 (planned)
- Sponsor
- National Center for Research Resources (NCRR) · NIH
- Sex
- All
- Age
- 0 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | relaxin |
Timeline
- Start date
- 1991-12-01
- Completion
- 1997-12-01
- First posted
- 1999-10-19
- Last updated
- 2005-06-24
Source: ClinicalTrials.gov record NCT00004380. Inclusion in this directory is not an endorsement.