A Novartis- sponsored Osilodrostat (LCI699) roll over drug study to assess the long-term safety in patients with Cushings syndrome which are judged by the study doctor to receive the continued treatment of Osilodrostat (LCI699) drug.
- Conditions
- Health Condition 1: E240- Pituitary-dependent Cushings disease
- Registration Number
- CTRI/2019/07/020063
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary objective is to evaluate the long term safety data with osilodrostat treatment i.e. adverse events (AEs) and serious adverse events (SAEs).Timepoint: 30 days after last dose
- Secondary Outcome Measures
Name Time Method To evaluate clinical benefit as assessed by the InvestigatorTimepoint: 30 days after last dose