An Open Label Extension Study of the Safety and Tolerability of LPCN 1144 for the Treatment of Subjects With Nonalcoholic Steatohepatitis (NASH) Who Have Completed the LPCN 1144-18-002 Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 10
- 主要终点
- Safety and Tolerability of LPCN 1144
研究概览
简要总结
This is an open-label extension to Study LPCN 1144-18-002. The study is aimed at evaluating the safety and tolerability of LPCN 1144 in adult men with NASH.
详细描述
This is a multicenter, open-label extension protocol to provide LPCN 1144, an investigational drug, to subjects with NASH who have completed the LPCN 1144-18-002 protocol. Enrolled subjects will be given LPCN 1144 for up to 36 weeks. Subjects will be seen periodically to evaluate safety clinical laboratory tests, tolerability of LPCN 1144, adverse events, and overall subject health. Subjects will be given the option of having a liver biopsy performed at Week 36.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects who have completed the 38 week study LPCN 1144-18-002 and wish to be treated with LPCN 1144
- •Subject must sign the Informed Consent Form to participate in the study
排除标准
- •Has participated or is participating in any other clinical (investigational) study after completion of LPCN 1144-18-002 study
- •Subjects who are currently receiving any androgens or estrogens
- •Subjects who are not willing to use adequate contraception for the duration of the study
- •Use of drugs historically associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens, anabolic steroids, valproic acid, other known hepatotoxins) for more than 2 weeks in the 2 years prior to enrollment
- •Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study
研究组 & 干预措施
Treatment A
LPCN 1144
干预措施: LPCN 1144 (Drug)
结局指标
主要结局
Safety and Tolerability of LPCN 1144
时间窗: Baseline to Week 36
Number of subjects presenting with a treatment-emergent adverse events
次要结局
未报告次要终点