CTRI/2019/07/020063进行中（未招募）2 期
An open-label, multi-center, roll-over study to assess long term safety in patients with endogenous Cushingâ??ssyndrome who have completed a prior Novartis-sponsoredosilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment withosilodrostat. - NI
ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
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
入选标准
- •1. Patient is currently participating in a Global Novartis-sponsored study receiving osilodrostat for any type of endogenous CS and has fulfilled all their requirements in the parent study.
- •2. Patient is currently benefiting from treatment with osilodrostat, as determined by the Investigator.
- •3. Patient has demonstrated compliance, as assessed by the Investigator, with the parent study protocol requirements.
- •4. Willingness and ability to comply with scheduled visits and treatment plans.
- •5. Written informed consent obtained prior to enrolling into the roll-over study before
- •evaluating the applicability of the subjectâ??s participating in the study.
- •ï?· If consent cannot be expressed in writing, it must
排除标准
- •1. Patient has been permanently discontinued from osilodrostat study treatment in a parent
- •Novartis-sponsor study.
- •2. Patients who are receiving osilodrostat in combination with unapproved or experimental
- •treatments for any type of endogenous CS.
- •3. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female
- •after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- •Pregnant or nursing (lactating) women
- •4. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 1 week of study after stopping medication. Highly effective contraception
- •methods include:
- •ï?· Total abstinence (when this is in line with the preferred and usual lifestyle of the
- •subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation
- •methods) and withdrawal are not acceptable methods of contraception
- •ï?· Female sterilization (have had surgical bilateral oophorectomy with or without
- •hysterectomy), total hysterectomy, or tubal ligation. at least six weeks before taking
- •study treatment. In case of oophorectomy alone, only when the reproductive status of
- •the woman has been confirmed by follow up hormone level assessment
- •ï?· Male sterilization (at least 6 months prior to baseline). The vasectomized male partner
- •should be the sole partner for that subject
- •ï?· Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of
- •contraception or placement of an intrauterine device (IUD) or intrauterine system
- •(IUS), or other forms of hormonal contraception that have comparable efficacy (failure
- •rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
研究者
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