PER-021-20尚未招募未知
A Phase 3, 182-week, Open-Label, Safety and Tolerability Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension (snOH) in Subjects with Primary Autonomic Failure
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Completion of Study 0170 and, in the opinion of the Investigator, would benefit from long-term treatment with TD-9855.
- •2. The subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study procedures (including any changes occurring in the subject’s current therapeutic regimen).
- •3. The subject must be willing to continue on treatment and must continue to meet all the inclusion criteria for the preceding study (Study 0170) except, a score of >4 in OHSA#1.
排除标准
- •1. Subjects may not be enrolled in another clinical trial, with the exception of purely observational studies, which are allowed.
- •2. Psychiatric, neurological, or behavioral disorders that may interfere with the ability of subjects to give informed consent or interfere with the conduct of the study.
- •3. Medical, laboratory, or surgical issues deemed by the Investigator to be clinically significant.
- •4. Hypersensitivity to TD-9855 or the formulation excipients.
研究者
相似试验
进行中(未招募)
1 期
Phase 3 Extension Study of TD-9855 for Treating snOH in Subjects with Primary Autonomic FailureSymptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic FailureMedDRA version: 20.0Level: LLTClassification code 10021102Term: Hypotension orthostatic symptomaticSystem Organ Class: 100000004866EUCTR2019-002425-30-ITTheravance Biopharma Ireland Limited110
进行中(未招募)
1 期
Phase 3 Extension Study of TD-9855 for Treating snOH in Subjects with Primary Autonomic FailureSymptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic FailureEUCTR2019-002425-30-ESTheravance Biopharma Ireland Limited84
进行中(未招募)
1 期
Phase 3 Extension Study of TD-9855 for Treating snOH in Subjects with Primary Autonomic FailureSymptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic FailureEUCTR2019-002425-30-FRTheravance Biopharma Ireland Limited84
进行中(未招募)
1 期
A Phase 3, 182-week, Open-Label, Safety and Tolerability Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension (snOH) in Subjects with Primary Autonomic FailureEUCTR2019-002425-30-EETheravance Biopharma Ireland Limited84
进行中(未招募)
1 期
A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Patients with Hemophilia BHemophilia BEUCTR2012-005489-37-ESCSL Behring GmbH97
