An open-label, multi-center, expanded access study of parireotide s.c. in patients with Cushing's disease (CSOM230B2406) (SEASCAPE) - CSOM230B2406 (SEASCAPE)

ovartis Pharma BV0 个研究点目标入组 2 人开始时间: 待定最近更新: 2024年5月6日

研究概览

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•1. male or female patients aged 18 years or above
•2. patients with confirmed diagnosis of Cushing's disease as evidenced by:
•* Mean urninary free cortisol of three 24-hour urine samples collected during the 3-week screening period above the upper limit of the laboratory non range
•* morning plasma ACTH within the normal or above normal range
•* either MRI confirmation of pituitary adenoma (greater than or equal to 0.6 cm), or
•inferior petrosal sinus gradient >3 after CRH stimulation (if IPSS had previously
•been performed without CRH, a central to peripheral prestimulation
•gradient > 2 is required. If IPSS had not previously been performed, IPSS
•with CRH stimulation is required).
•3. Patients with de novo Cushing*s disease must not be considered as candidates for pituitary
•4. Karnofsky performance status >60
•5. For patients on previous medical treatment for Cushing*s disease the following washout
•periods must be completed before screening assessments are performed (see protocol section 5.2, item 6 for details).

•1. Radiotherapy of the pituitary <4 weeks before screening or patient who has not recovered
•from side effects
•2. Patients with compression of the optic chiasm causing acute clinically significant visual
•field defect
•3. Patients with Cushing*s syndrome due to ectopic ACTH secretion
•4. Patients with hypercortisolism secondary to adrenal tumors or nodular (primary) bilateral
•adrenal hyperplasia
•5. Patients who have a known inherited syndrome as the cause for hormone over secretion
•6. Patients with a diagnosis of glucocorticoid-remedial aldosteronism (GRA)
•7. Patients who have undergone major surgery within 1 month prior to screening
•8. Patients with known gallbladder or bile duct disease, acute or chronic pancreatitis (see protocol page 26 for exceptions)
•9. Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1C >8%
•10. Patients who have clinically significant impairment in cardiovascular function or are at
•risk thereof (see protocol for details)
•11. Female patients who are pregnant or lactating, or are of childbearing potential and not
•practicing a medically acceptable method of birth control.

发起方

ovartis Pharma BV