2025-522964-33-00招募中4 期
A Phase 4, Multicenter, Double-blind, Study to Investigate the Efficacy, Safety, and Tolerability of 3 Active Doses of Respreeza® / Zemaira® Weekly Intravenous Infusions Administered over 3 Years as Longterm Maintenance Therapy in Adult Subjects with Emphysema Related to Alpha1 Antitrypsin Deficiency
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 33
- 试验地点
- 4
- 主要终点
- Annual rate of change in adjusted lung density
研究概览
简要总结
This is a study to primarily assess the ability of the 2 active doses of CE1226 (Respreeza / Zemaira) to influence the annual lung density decline rate as compared to the marketed dose of CE1226 in participants with AATD.
研究设计
- 分配方式
- Randomized
- 主要目的
- Overall study
- 盲法
- Double (Monitor, Analyst, Subject, Investigator, Carer)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to (>=) 18 and less than or equal to (<=) 65 years at the time of providing written informed consent. • Confirmed diagnosis of emphysema related to AATD with either the PiZZ, PiZ(null), or Pi(null/null) genotype with documented serum AAT levels less than (<) 11 micrometer (μM) (or < 50 mg/dL [milligram/deciliter]) at any time before the first administration of CE1226 on Day 1 (Baseline).
排除标准
- •Participants should not have acute illness or pulmonary exacerbation within 6 weeks before the first administration of CE1226 on Day 1 (Baseline). • Participants should not have previously received gene therapy for AATD at any point. • Participants with liver disease secondary to AATD.
研究组 & 干预措施
Respreeza 4,000 mg powder and solvent for solution for infusion., Respreeza 1,000 mg powder and solvent for solution for infusion.
Test
干预措施: Respreeza 4,000 mg powder and solvent for solution for infusion. (Drug)
Respreeza 4,000 mg powder and solvent for solution for infusion., Respreeza 1,000 mg powder and solvent for solution for infusion.
Test
干预措施: Respreeza 1,000 mg powder and solvent for solution for infusion. (Drug)
结局指标
主要结局
Annual rate of change in adjusted lung density
Annual rate of change in adjusted lung density
次要结局
- 1. Annual rate of change in forced expiratory volume in 1 second percent predicted (FEV1%) 2. Annual rate of change in diffusion capacity of carbon monoxide (DLco) 3. Number of severe pulmonary exacerbations 4. Duration of severe pulmonary exacerbations 5. Number of participants experiencing treatment emergent adverse events (TEAEs) 6. Percentage of participants experiencing TEAEs
研究者
Study Director
Scientific
CSL Behring LLC
研究点 (4)
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