Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis

Phase 2

Completed

• Conditions: Systemic Sclerosis

• Registration Number: NCT00004380
• Lead Sponsor: National Center for Research Resources (NCRR)

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.

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.

Study Timeline

• Study Start: 1991-12
• Study Completion: 1997-12
• Study First Submitted: 1999-10-18
• Study First Submitted QC: 1999-10-18
• Study First Posted: 1999-10-19
• Status Verified: 2004-07
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified