NCT03767452Unknown4 期
A Phase 4, Single-Center, Multiple-Dose, Open-Label Trial to Evaluate the Efficacy of Additional Xiaflex® Treatment in Patients With Peyronie's Disease Recurrence, Worsening, or Incomplete Response After Prior Xiaflex® Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in the degree of penile curvature
研究概览
简要总结
Subjects who have had an incomplete response to previous Xiaflex® will receive up to 4 additional cycles of treatment.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent to participate in the study.
- •Male aged ≥18 years old at screening.
- •Previously received Xiaflex® treatment and had a partial or complete response.
- •Partial response is defined as receiving ≤ 4 cycles of Xiaflex® and achieving a penile curvature of ≥ 15 degrees and < 90 degrees.
- •Complete response is defined as receiving ≤ 4 cycles of Xiaflex® and achieving a penile curvature of < 15 degrees.
- •Has a diagnosis of Peyronie's disease with a penile curvature of ≥ 30 and ≤ 90 degrees at the screening visit.
- •Has a penile curvature of at ≥ 30 degrees in the dorsal, lateral, or dorsal/lateral plane at the screening visit. It must be possible to delineate the single plane of maximal curvature for evaluation during the study.
- •Able and willing to comply with restrictions where intercourse or any other sexual activity is prohibited during each treatment cycle and for at least 2 weeks after each injection cycle.
- •Able and willing to perform home modeling sessions between injection cycles.
- •Is in good health based on medical history evaluation and in the judgment of the principal investigator.
排除标准
- •Has a penile curvature of < 30 degrees or > 90 degrees at the screening visit.
- •Previous allergic reaction to XIAFLEX®.
- •Has any of the following conditions:
- •Chordee in the presence or absence of hypospadias
- •Thrombosis of the dorsal penile artery and or vein
- •Infiltration by a benign or malignant mass resulting in penile curvature
- •Infiltration by an infectious agent, such as lymphogranuloma venereum
- •Ventral curvature from any cause
- •Presence of an active sexually transmitted disease
- •Known active hepatitis B or C
- •Known human immune deficiency virus (HIV)
- •Has previously undergone surgery for Peyronie's disease.
- •Has an erection which, in the opinion of the investigator, is insufficient to accurately measure the subject's penile deformity after administration of the prostaglandin E1 (PGE1), Trimix®, or similar erection inducing agent.
- •Has a calcified plaque that, in the opinion of the investigator, would prevent proper administration of the study medication.
- •Has an isolated hourglass deformity of the penis.
- •Has a plaque causing a curvature of the penis located proximal to the base of the penis where injection of local anesthetic would interfere with the injection of Xiaflex®.
- •Has received intralesional or injection therapy for Peyronie's disease including interferon, verapamil, or Xiaflex® < 6 months prior to screening.
- •Has used antiplatelet or anti-coagulants (e.g. coumadin, Plavix®, Eliquis®, Effient®) within 7 days prior to each Xiaflex® injection. Daily aspirin of 81 mg is acceptable.
- •Has had extracorporeal shock wave therapy (ESWT) for the correction of Peyronie's disease within the 6 months prior to screening or plans to have ESWT at any time during the study.
- •Has uncontrolled hypertension as determined by the investigator.
- •Has a recent history of stroke, bleeding, or other significant medical condition which, in the investigator's opinion, would make the subject unsuitable for enrollment in the study.
- •Has a planned surgical procedure during anticipated study participation.
- •Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits.
- •Has received investigational drug or treatment within 30 days of the first dose Xiaflex®.
研究组 & 干预措施
Single-Arm
Experimental
Xiaflex® 0.58 mg, 2 injections separated by 1 to 3 days, repeated after 6 weeks for up to 4 treatment cycles.
干预措施: Xiaflex® 0.58 mg (Drug)
结局指标
主要结局
Change in the degree of penile curvature
时间窗: From Screening up to 24 weeks
Measurable change in the curvature of penis
次要结局
未报告次要终点
研究者
研究点 (1)
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