NL-OMON52441招募中3 期
Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PRX-102) in Patients with Fabry Disease - PB-102-F60/Brilliance Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Completion of study PB-102-F20 or PB-102-F30, or completed at least 48
- •months in study PB-102-F03.
- •2. The patient signs informed consent
- •3. Female patients and male patients whose co-partners are of childbearing
- •potential agree to use a medically ccepted, highly effective method of
- •contraception. These include combined (estrogen- and
- •progestogen-containing) hormonal contraception associated with inhibition of
- •ovulation (oral, intravaginal, or transdermal) supplemented with a barrier
- •method (preferably male condom), progestogen-only hormonal contraception
- •associated with inhibition of ovulation (oral,
- •injectable, or implantable) supplemented with a barrier method (preferably male
- •condom), intrauterine device (IUD), intrauterine hormone-releasing system
- •(IUS), bilateral tubal occlusion,
- •vasectomised partner, or sexual abstinence. Contraception should be used for 2
- •weeks after treatment termination.
排除标准
- •Presence of any medical, emotional, behavioral or psychological condition that,
- •in the judgment of the Investigator would interfere with patient compliance
- •with the requirements of the study.
研究者
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