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临床试验/EUCTR2015-001292-51-DE
EUCTR2015-001292-51-DE进行中(未招募)1 期

Follow-Up Study in Patients with Acromegaly Previously Participating in Chiasma Study CH-ACM-01

Chiasma, Inc.0 个研究点目标入组 98 人开始时间: 2015年4月8日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
Chiasma, Inc.
入组人数
98

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1. Patients who received at least one dose of octreotide capsules during CH ACM-01;
  • 2. Patients who did not re-initiate medical treatment for acromegaly within the two week follow-up period OR patients who have been responders (IGF-1 less than or equal to 1.3 × ULN and GH <2.5 ng/mL at the end of treatment in the CH-ACM-01 study) and re-initiated treatment within the two week follow-up period. (Note: A list of patients that meet the above inclusion criteria will be provided by the Sponsor); and
  • Patients are able to understand and sign written informed consent to participate in the study.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 75
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 23

排除标准

  • 未提供

研究者

发起方
Chiasma, Inc.

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