ISRCTN17914189进行中（未招募）2 期
A Phase II long-term open-label trial to assess the safety and efficacy of repeat dosing of STAR-0215 in adult patients with hereditary angioedema (the ALPHA-SOLAR trial)
Astria Therapeutics, Inc. (USA)0 个研究点目标入组 56 人开始时间: 2024年7月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
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
- 性别
- All
入选标准
- •Open to participants from STAR-0215-201 (NCT05695248) who have met one of the following conditions:
- •1. Completed STAR-0215-201 (follow up through 6 months after their last dose)
- •2. Eligible for STAR-0215-201 and entered the Run-In period but did not qualify for the Treatment Period because they did not meet the criterion for the minimum number of HAE attacks
- •3. Eligible for STAR-0215-201 and entered the Run-In period but did not complete it for reasons other than not meeting the criterion for the minimum number of HAE attacks (eligibility requires consultation with the Medical Monitor)
- •4. Discontinued STAR-0215-201 (for reasons other than safety) after having completed at least 84 days of trial follow-up since their last dose of STAR-0215 (eligibility requires consultation with the Medical Monitor)
排除标准
- •1. Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-esterase inhibitor protein (also known as HAE Type III), idiopathic angioedema, or angioedema associated with urticaria.
- •2. Any exposure to angiotensin-converting enzyme inhibitors or any estrogen-containing medications with systemic absorption (such as hormonal contraceptives or hormone replacement therapy) within 28 days prior to Screening
- •3. Any exposure to androgens (for example, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within 7 days prior to Screening.
- •4. Use of therapies prescribed for the prevention of HAE attacks prior to Screening:
- •4.1. Lanadelumab within 90 days
- •4.2. Berotralstat within 21 days
- •4.3. All other prophylactic therapies, discuss with the Medical Monitor
- •Note: Other inclusion and exclusion criteria may apply.
研究者
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