EUCTR2019-001044-22-GB进行中（未招募）1 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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
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)Documented diagnosis of HAE-1/HAE-2 (for inclusion in Part A) or HAE-nC1-INH (for inclusion in Part B)
- •2)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. Complete the AAS questionnaire on a daily basis (minimum of 4 daily assessments per week) for the duration of the Screening Period.
- •3)Access to, and the ability to use, = 1 acute medication(s) to treat angioedema attacks
- •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 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Anticipated use of short-term prophylaxis for angioedema attacks for a pre-planned procedure during the screening or study periods
- •2) Concurrent diagnosis of any other type of recurrent angioedema, including acquired or idiopathic angioedema
- •3) History of acquired coagulopathies or bleeding diasthesis
- •4) Active infection with HIV, hepatitis C or hepatitis B diagnosed by initial serological testing and confirmed with RNA testing, or prior treatment for hepatitis C. Patients at Screening who test positive by serology, but negative by RNA may be allowed in consultation with the Sponsor Medical Monitor.
- •5) Patients with a history of acquired coagulopathies or bleeding diathesis (e.g. thrombocytopenia, disseminated intravascular coagulation, coagulopathy of liver disease, drug-induced platelet dysfunction, hyperfibrinolysis, acquired clotting factor inhibitors) and inherited bleeding disorders (e.g., hemophilia A, hemophilia B, other clotting
- •factor deficiencies, qualitative platelet disorders, inherited thrombocytopenia, vascular abnormalities).
- •6) Any clinically significant renal or hepatic diseases.
- •7) 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
- •8) Treatment with another investigational drug or biological agent within 1 month or 5 half-lives, whichever is longer, of screening
- •9) Exposure to any of the following medications:
- •-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
- •-Chronic prophylaxis with lanadelumab within 6 months prior to screening
- •-Oligonucleotides (including small interfering ribonucleic acid [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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