NCT01846793已完成3 期
Phase 3 Multicenter Prospective Open Label Clinical Safety Evaluation of Re-Injection of NX-1207 for the Treatment of BPH: Two Doses 1-8 Years Apart
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
This study is designed to demonstrate the safety and efficacy of a second transrectal intraprostatic injection of NX-1207 given to subjects with Benign Prostatic Hyperplasia (BPH) who previously received an injection of NX-1207 in an earlier U.S. clinical trial of NX-1207.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Be male aged 45 or older.
- •Sign an informed consent form.
- •Be in good health.
- •Received NX-1207 in a previous completed study (other than NX02-0020) or received NX-1207 or placebo in a concurrent U.S. study (NX02-0017 and NX02-0018) and completed their V10 (365 day) visit.
- •Have Prostate Gland Volume ≥ 25 mL (25 g).
排除标准
- •Surgery or minimally invasive surgical therapy (MIST) for treatment of BPH after first NX-1207 injection
- •Post-void residual urine volume > 200 mL
- •Presence of a symptomatic median lobe of the prostate
- •History of use of self-catheterization for urinary retention.
- •Urinary retention in the previous 12 months.
- •Prostatitis
- •Urinary tract infection more than once in the past 12 months
- •Prostate or bladder cancer.
- •Prostate-Specific Antigen (PSA) ≥ 10 ng/mL
- •Poorly controlled diabetes
- •History or evidence of illness or condition that may interfere with study or endanger subject
- •Participation in a study of any investigational drug (other than NX-1207) or investigational device within the previous 90 days
- •Use of specific prescribed medications that may interfere with study or endanger subject
研究组 & 干预措施
Open Label Injection of NX-1207
Experimental
Intraprostatic injection of 2.5 mg NX-1207
干预措施: NX-1207 (Drug)
结局指标
主要结局
Safety
时间窗: 180 days
Safety parameters as determined by Adverse Events, clinical laboratory test results, vital signs, physical exam and electrocardiogram (ECG).
次要结局
- Change in Urinary Peak Flow(90 days.)
- Prostate Volume Change(90 days)
- Symptomatic Improvement(180 days)
研究者
研究点 (1)
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