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临床试验/NL-OMON49723
NL-OMON49723已完成2 期

A Randomized, Double Blind, Placebo Controlled, Phase 2a Study to Assess the Clinical Efficacy of ISIS 721744, a Second Generation Ligand Conjugated Antisense Inhibitor of Prekallikrein, in Patients with Hereditary Angioedema - ISIS 721744-CS2

Ionis Pharmaceuticals, Inc.0 个研究点目标入组 8 人开始时间: 待定最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
8

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

年龄范围
18 至 99(—)

入选标准

  • - Documented diagnosis of HAE-1/HAE-2 (for inclusion in Part A) or HAE-nC1-INH
  • (for inclusion in Part B);
  • - Participants must experience a minimum of 2 HAE attacks (assessed by the
  • Angioedema Activity Score [AAS] and confirmed by the investigator) during the
  • screening period;
  • - Access to, and the ability to use, 1 or more acute medication(s) to treat
  • angioedema attacks.

排除标准

  • - Anticipated use of short-term prophylaxis for angioedema attacks for a
  • pre-planned procedure during the Screening or Study Periods.
  • - Concurrent diagnosis of any other type of recurrent angioedema, including
  • acquired or idiopathic angioedema.
  • - History of acquired coagulopathies or bleeding diathesis.
  • - Active infection with human immunodeficiency virus (HIV), hepatitis C or
  • chronic hepatitis B.
  • - Malignancy within 5 years, except for basal or squamous cell carcinoma of the
  • skin or carcinoma in situ of the cervix that has been successfully treated.
  • - Treatment with another investigational drug or biological agent within 1
  • month or 5 half-lives, whichever is longer, of Screening.
  • - Exposure to any of the following medications:
  • a. Angiotensin-converting enzyme (ACE) inhibitors or any estrogen containing
  • medications with systemic absorption (such as oral contraceptive or hormonal
  • replacement therapy) within 4 weeks prior to Screening.
  • b. Chronic prophylaxis with Lanadelumab within 10 weeks prior to Screening.
  • c. Oligonucleotides (including small interfering RNA) within 4 months of
  • Screening if single dose received, or within 12 months of Screening if multiple
  • doses received.

研究者

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