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 treatment
- Conditions
- Health Condition 1: E240- Pituitary-dependent Cushings disease
- Registration Number
- CTRI/2021/04/032853
- Lead Sponsor
- RECORDATI AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Patients eligible for inclusion in this study have to meet all of the following criteria:
1. Patient is currently participating in a Novartis-sponsored study receiving pasireotide (LAR and/or s.c.) on monotherapy or combination therapy (for Cushingââ?¬•s Disease or Acromegaly) and has fulfilled all required assessments in the parent study and patients that are benefiting from the study treatment have no other alternatives.
2. Patient is currently benefiting from the treatment with pasireotide, as determined by the
investigator
3. Patient has demonstrated compliance, as assessed by the investigator, with the parent study requirements.
4. Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.
5. Written informed consent obtained prior to enrolling in roll-over study and receiving study medication.
�If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
Patients eligible for this study must not meet any of the following criteria
1. Patient has been permanently discontinued from pasireotide study treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason.
2. 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.
3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study treatment and for 30 days after the final dose of pasireotide s.c. and 84 days after the final dose of pasireotide LAR. Highly effective contraception is defined as either
Total abstinence (when this is in line with the preferred and usual lifestyle of the patientt. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Female sterilization (have had surgical bilateral oophorectomy with or without 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.
Male sterilization (at least 6 months prior to enrolling). For female patients on the study the vasectomized male partner should be the sole partner for that patient.
Use of oral, 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.
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 (ie age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), 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 is she considered not of child-bearing potential.
Sexually active males unless they use a condom during intercourse while taking drug and for 1 months after pasireotide s.c. last dose and 3 months after pasireotide LAR last dose and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
If a study patient or partner becomes pregnant or suspects being pregnant during the study treatment or within 1 month after the final dose of pasireotide s.c. or 84 days after the final dose of pasireotide LAR, the Study Doctor needs to be informed immediately and ongoing study treatment with pasireotide has to be stopped immediately. For patients taking pasireotide LAR, the future dose injections will be cancelled
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method �To evaluate long term safety data Ie SAEs and AEs with pasireotide (s.c. and/or LAR) in a Novartis-sponsored study and have fulfilled all required assessments in the parent studyTimepoint: Frequency and severity of <br/ ><br>AEs/SAEs
- Secondary Outcome Measures
Name Time Method To evaluate clinical benefit as assessed by the investigatorTimepoint: At scheduled visits i.e. Visit 2,3,4 etc.