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临床试验/NCT00004380
NCT00004380已完成2 期

Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis

National Center for Research Resources (NCRR)0 个研究点目标入组 1 人开始时间: 1991年12月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
主要目的
Treatment

入排标准

年龄范围
0 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • PROTOCOL ENTRY CRITERIA:
  • -Disease Characteristics--
  • Progressive systemic sclerosis (scleroderma)
  • No pregnant or nursing women

排除标准

  • 未提供

研究者

发起方
National Center for Research Resources (NCRR)
申办方类型
Nih

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