NCT05422976已完成不适用
Safety and Tolerability of a Single Intra-articular Highly Concentrated Hyaluronic Acid Injection in the Treatment of Symptomatic Knee Osteoarthritis : Pilot, 6-months, Open-label, Single-arm Investigation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aptissen SA
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Safety and tolerability
研究概览
简要总结
Prospective, single arm, pilot study to assess the safety and tolerability of a single intra-articular injection of EVI-01 for the treatment of symptomatic knee osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eighteen (18) years old or above;
- •Patient signed informed consent form;
- •Patients with stable symptoms related to knee osteoarthritis for at least 3 months prior to screening;
- •Failure, inadequate response or intolerance to analgesics and/or NSAIDs or low-grade opioids;
- •Kellgren-Lawrence radiographic stage: II-III diagnosed in the previous 12 months;
- •WOMAC average pain index score > 40 mm and < 90 (on a VAS 0-100 mm) on the knee to be treated;
- •Difference ≥ 10 mm between the WOMAC average pain score of the knee to be treated and WOMAC average pain score of the contralateral knee at screening;
- •Body Mass Index (BMI) inferior to 35 kg/m2 (weight/height).
排除标准
- •Concomitant inflammatory joint disorder;
- •Had received previous visco-supplementation treatment in the study knee within 6 months or intra articular corticosteroids within 3 months* prior to inclusion;
- •Infection in or around the study knee;
- •Relevant skin disease in the area of injection site;
- •Documented presence of injury or trauma of the study knee at screening, including evidence of a subchondral fracture, meniscal lesion, presence of bone or cartilage fragments in the study knee;
- •History of allergy or intolerance to sodium hyaluronate;
- •Documented presence of osteonecrosis in one or both knees;
- •Inability to understand the study procedure;
- •Participation in another clinical trial within 30 days prior to screening;
- •Ongoing therapy with daily dosage > 101 mg of acetylsalicylic acid as part of cardiovascular preventive treatment. If dose < 101 mg, it must be maintained during the study;
- •Pregnant or breast-feeding at inclusion.
- •1 month = 30 days
结局指标
主要结局
Safety and tolerability
时间窗: 6 months
Primary objective of this study is to assess the safety and tolerability of EVI-01 following single intraarticular administration in the knee joint, assessed with adverse events monitoring throughout the follow up duration of six months.
次要结局
- Change in patient-reported pain intensity(7 days)
- Change in WOMAC index(6 months)
- Patient satisfaction for the overall treatment effect(6 months)
- Physician satisfaction for the overall treatment effect(6 months)
研究者
研究点 (2)
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