Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004380
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES I Determine whether parenteral relaxin improves skin tightness Raynauds 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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SUMC-37488 | None | None | None |