jRCT2053240149招募中不适用
Clinical trial of selective treatment of EVA-001 in patients allocated to the hyaluronic acid group after completion of EVA-001-02 study
MEDIPOST K.K.0 个研究点目标入组 65 人开始时间: 2024年6月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 65
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 80age old under（—）
- 性别
- All
入选标准
- •Patients who meet all of the following criteria at baseline will be included.
- •Patients who participated in the EVA-001-02 study, were allocated to the hyaluronic acid control group and completed Visit
- •Men and women aged between 20 and 80 years at the time of obtaining consent.
- •Patients with 2-9 cm2 of lesion damage area that is the main cause of their clinical symptoms
- •For women of childbearing potential, patients who agree to maintain contraceptive status for the duration of the study
- •Patients who have voluntarily decided to participate in the trial and have signed the consent form
排除标准
- •Patients who meet any of the following criteria shall be excluded.
- •Patients with osteoarthritis of the knee with K&L Grade 1 or 4 on simple radiographic examination
- •Patients with an FTA of less than 174 and more than 180
- •Patients with autoimmune diseases or a history of autoimmune diseases
- •Patients with infections requiring parenteral antibiotics or suspected of having such infections
- •Patients with serious cardiovascular disease (myocardial infarction, congestive heart failure, uncontrolled hypertension, or other serious cardiac disease) or a history of such disease
- •Patients with gout or suspected gout
- •Patients with blood clotting abnormalities
- •Patients with serious renal function abnormalities
- •Patients with serious liver damage
- •Patients with serious medical conditions
- •Patients with malignancy or suspected malignancy
- •Patients who are pregnant or currently breastfeeding
- •Patients who have received intra-articular drugs such as hyaluronic acid injections within the past 8 weeks
- •Patients with mental disorders or a history of mental disorders
- •Patients who are habitual drinkers and are dependent or suspected of being alcoholic
- •Patients with nicotine dependence or suspected nicotine dependence
- •Patients with chronic inflammatory joint diseases (e.g., rheumatoid arthriis)
- •Patients who have received immunosuppressive drugs such as cyclosporine A or azathioprine within the past 6 weeks
- •Patients with injuries to the anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament and lateral collateral ligament of the knee to be transplanted with mobility.
- •Patients who are scheduled to undergo surgical treatment of the target knee joint, such as treatment for meniscus injury or ligament reconstruction, or who have undergone such surgical treatment within the past 6 months.
- •Patients with paralysis due to nerve or muscle disease on the side of the knee joint cartilage damage or defect (affected side of the leg)
- •Patients with a partial arthroplasty in the knee to be transplanted.
- •Patients with a history of serious hypersensitivity to bovine-derived or porcine-derived ingredients of this product
- •Patients with a history of severe hypersensitivity or anaphylactic shock to gentamicin
- •Patients with a history of severe hypersensitivity or anaphylaxis to sodium hyaluronate or products containing hyaluronate ity or anaphylactic shock to gentamicin
- •Patients with a history of transplantation or multiple blood transfusion
- •Patients who participated in a clinical trial other than the EVA-001-02 trial within the last three months
- •Patients who have been at rest for a long period of time within the past 3 months
- •Patients with a history of contraindications for cartilage magnetic resonance imaging (MRI) or contrast media if contrast media is used.
- •Other patients deemed unfit by the (sub)investigator, taking into account the assessment of safety and efficacy (e.g. subjective judgement).
结局指标
主要结局
-
Incidence of adverse events (including laboratory abnormalities)
次要结局
- WOMAC scale(52 weeks post-treatment)
- 100 mm VAS value(52 weeks post-treatment)
- IKDC score(52 weeks post-treatment)
- WOMAC subscale(52 weeks post-treatment)
- KOOS scale(52 weeks post-treatment)
研究者
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