CTRI/2021/04/033241已完成2 期
An open-label, multi-center, roll-over study to assess long term safety inpatients with endogenous Cushing’s syndrome who have completed a priorNovartis-sponsored osilodrostat (LCI699) study and are judged by theinvestigator to benefit from continued treatment with osilodrostat.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- RECORDATI AG
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- To evaluate long term safety data
研究概览
简要总结
Dear Sir/Mam,
This is an ongoingstudy recently transferred to IQVIA from new sponsor Recordati. The New SponsorRecordati has bought all the rights of Osilodrostat(LCI699) from Novartis (earlier Novartis CTRIReg. no.: CTRI/2019/07/020063 [Registered on: 08/07/2019].
May werequest you to update the Date of first enrollment Global: 05 Oct 2018 andIndia:15 Jul 2019 and India Recruitment status to completed.
The clinical study to evaluate long term safety in patients withendogenous Cushing’s syndrome who have completed previous Novartis-sponsoredOsilodrostat (LCI699) drug study and are judged by the investigator to benefitfrom continued treatment with Osilodrostat drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •Patient is currently benefiting from treatment with osilodrostat, as determined by the Investigator.
- •Patient has demonstrated compliance, as assessed by the Investigator, with the parent study protocol requirements.
- •Willingness and ability to comply with scheduled visits and treatment plans.
- •Written informed consent obtained prior to enrolling into the roll-over study before evaluating the applicability of the subject’s participating in the study.
- •5.1 If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
排除标准
- •Patient has been permanently discontinued from osilodrostat study treatment in a parent Novartis-sponsor study.
- •Patients who are receiving osilodrostat in combination with unapproved or experimental treatments for any type of endogenous CS.
- •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 evaluation.
- •Pregnant or nursing (lactating) women
- •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 4.1 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 4.2 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 4.3 Male sterilization (at least 6 months prior to baseline).
- •The vasectomized male partner should be the sole partner for that subject 4.4 Use of oral (estrogen and progesterone) injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate less than 1 percent), for example hormone vaginal ring or transdermal hormone contraception.
- •In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study, treatment and must be used in combination with a barrier method (male condom).
- •Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or total hysterectomy, or tubal ligation at least six weeks ago.
- •In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment, it will be considered not of childbearing potential.
结局指标
主要结局
To evaluate long term safety data
时间窗: 30 days after last dose
次要结局
- To evaluate clinical benefit as assessed by the Investigator(30 days after last dose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
This is an open label, multi-center pasireotide roll-over protocol for patients who have completed a previous Novartis sponsored pasireotide study and are judged by the investigator to benefit from continued pasireotide treatmentCTRI/2021/04/032853RECORDATI AG158
尚未招募
不适用
Efficacy and Safety of the Drug Product CaspofunginCTRI/2017/04/008362JSC Pharmasyntez Russia244
终止
3 期
A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)Alzheimer DiseaseNCT04374253Hoffmann-La Roche1,382
招募中
不适用
Onderzoek naar de werkzaamheid van toevoeging van Cetuximab aan de combinatie van radiotherapie en Cisplatin bij patiënten met niet-kleincellig longkanker.Cetuximab, non-small lung carcinoma, cisplation, radiotherapy, locally advancedNL-OMON21439KI-AV110
招募中
1 期
A study to learn how gadoquatrane moves into, through, and out of the body and how safe it is in children aged 0 to less than 18 years, who will undergo a contrast enhanced MRICTIS2022-501883-17-00Bayer AG141