Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis

This study has been completed.
Sponsor:
Collaborators:
Stanford University
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004380
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: July 2004
  Purpose

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.


Condition Intervention Phase
Systemic Sclerosis
Drug: relaxin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 1
Study Start Date: December 1991
Estimated Study Completion Date: December 1997
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Progressive systemic sclerosis (scleroderma)
  • No pregnant or nursing women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004380

Sponsors and Collaborators
Stanford University
Investigators
Study Chair: G. Scott Herron Stanford University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004380     History of Changes
Other Study ID Numbers: 199/12015, SUMC-37488
Study First Received: October 18, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
arthritis & connective tissue diseases
rare disease
systemic sclerosis

Additional relevant MeSH terms:
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014