NCT04065074已完成2 期
A Single-arm, Open-label Study to Evaluate a Procedure for Intra-articular (IA) Injection of FX006 in Patients With Osteoarthritis (OA) of the Hip
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 5
- 主要终点
- Number of Patients With Successful Study Drug Administrations
研究概览
简要总结
This is a multi-center, single-arm, open-label study of FX006 in patients with hip OA. A maximum number of approximately 30 patients may be enrolled in this protocol. All enrolled patients will receive a single intra-articular (IA) injection of FX006.
详细描述
This is a multi-center, single-arm, open-label study in patients with hip OA to evaluate a procedure for intra-articular injection of FX006 in patients with hip OA. A maximum number of approximately 30 patients may be enrolled in this protocol.
All enrolled patients will receive a single intra-articular (IA) injection on Day 1 and be followed for 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
- •Patients 40 to 80 years of age, inclusive, on the day of consent
- •Body Mass Index (BMI) ≤ 40 kg/m^2
- •Has a documented clinical diagnosis of unilateral or bilateral hip OA for at least six months
- •Kellgren-Lawrence (KL) Grade 2 or 3 in the index hip as confirmed by local read of X-ray obtained during Screening or ≤ 6 months of Screening visit
- •Has clinically significant pain in the index hip
排除标准
- •Has a history of hypersensitivity to triamcinolone acetonide, PLGA or lidocaine
- •Is receiving anticoagulants (including warfarin, dabigatran, rivaroxaban, apixaban or low molecular weight heparin, ritonavir or cobicistat)
- •Has had any previous surgery on the index hip
- •Presence of surgical hardware or other foreign body in the index hip
- •Has a history of infection of the index hip
- •Has a diagnosis of other disorders in the index hip that can cause pain
- •Has received any intra-articular injection in the index hip of corticosteroids, investigational (including FX006) or marketed (including Zilretta®) within the 3 months prior to Screening
- •Has had trauma to the index hip in the past 3 months requiring immobilization
- •Has a history or evidence of active or latent systemic fungal or mycobacterial infection (including tuberculosis), or of ocular herpes simplex
- •Has within the past 3 months received corticosteroids by mouth, or by parenteral injection. Multiple courses or chronic intermittent use of inhaled, intranasal, or topical steroids is also exclusionary. Single courses of 14 days or less by those routes are permitted
- •Has, at screening, or any time prior to day of scheduled injection (Day 1), clinical suspicion of local or systemic infection, including any infection in the index leg.
- •Has a history of or active significant concomitant illness (known or suspected)
- •Any bacterial or viral infection requiring parental antibiotics within 4 weeks of Day 1 or oral antibiotics within 2 weeks of Day 1
- •Is a woman who is pregnant, nursing, lactating, or plans to become pregnant during the study
- •Is a man who plans to conceive during the study
研究组 & 干预措施
FX006 32 mg
Experimental
Single intra-articular (IA) injection of FX006 32 mg
干预措施: FX006 32 mg (Drug)
结局指标
主要结局
Number of Patients With Successful Study Drug Administrations
时间窗: Day 1
Successful study drug administration, defined as Injector reporting complete study drug administration.
次要结局
未报告次要终点
研究者
研究点 (5)
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