A RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PAHSE III STUDY TO EVALUATE THE EFFICACYAND SAFETY OF PASIREOTIDE LAR IN PATIENTS WITH CUSHING´S DISEASE.

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 9 人开始时间: 2012年6月22日最近更新: 2023年9月4日

试验速览

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•PATIENTS ELIGIBLE FOR INCLUSION IN THIS STUDY HAVE TO MEET ALL OF THE FOLLOWING CRITERIA:
•1. WRITTEN INFORMED CONSENT OBTAINED PRIOR TO ANY SCREENING PROCEDURES.
•ADULTS PATIENTS WITH CONFIRMED DIANOSIS OF ACTH-DEPENDANT CUSHING´S DISEASE AS EVIDENCED BY ALL OF THE FOLLOWING:
•A. THE MEAN OF THERE 24-HOUR URINE SAMPLES COLLECTED WITHIN 2 WEEKS ≥ 1.5 X ULN AND ≤ 5 X ULN (AS DETERMINED BY THE CENTRAL LAB OF THIS STUDY).
•B. MORNING PLASMA ACTH WITHIN THE NORMAL OR ABOVE NORMAL RANGE.
•C. EITHER MRI CONFIRMATION OF PITUITARY ADENOMA > 6 MM, OR INFERIOR PETROSAL SINUS GRADIENT > 3 AFTER CRH STIMULATION FOR THOSE PATIENTS WITH A TUMOR LESS THAN OR EQUAL TO 6 MM*. FOR PATIENTS WHO HAVE HAD PRIOR PITUITARY SURGERY, HISTOPATHOLOGY CONFIRMING AN ACTH STAINING ADENOMA.
•* IF IPSS HAD PREVIOUSLY BEEN PERFORMED WITHOUT CRH (E.G. WITH DDAVP), THEN A CENTRAL TO PERIPHERAL PRE-STIMULATION 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 CAN BE INCLUDED ONLY IF THEY ARE NOT CONSIDERED CANDIDATES FOR PITUITARY SURGERY (E.G. POOR SURGICAL CANDIDATES, SURGICALLY UNAPPROACHABLE TUMORS, PATIENTS WHO REFUSE TO HAVE SURGICAL TREATMENT).

•PATIENTS ELEGIBLE FOR THIS STUDY MUST NOT MEET ANY OF THE FOLLOWING CRITERIA:
•1. PATIENTS WHO ARE CONSIDERED CANDIDATES FOR SURGICAL TREATMENT AT THE TIME OF STUDY ENTRY.
•2. PATIENTS WHO HAVE RECEIVED PITUITARY IRRDIATION WITHIN THE LAST TEN YEARS PRIOR TO VISIT 1.
•3. PATIENTS WHO HAVE HAD ANY PREVIOUS PASIREOTIDE TREATMENT.
•4. PATIENTS WHO HAVE BEEN TREATED WITH MITOTANE DURING THE LAS 6 MONTHS PRIOR TO VISIT 1.
•5. PATIENTS WITH COMPRESSION OF THE OPTIC CHIASM CAUSING ANY VISUAL FIELD DEFECT THAT REQUIRES SURGICAL INTERVENTION.
•6. DIABETIC PATIENTS WITH POOR GLYCEMIC CONTROL AS EVIDENCED BY HBA1C > 8 %.
•7. PATIENTS WITH RISK FACTORS FOR TORSADE DE POINTES, I.E. PATIENTS WITH A BASELINE QTCF > 470 MS, HYPOKALEMIA, HYPOMAGNESEMIA, UNCONTROLLED HYPOTHYROIDISM, FAMILY HISTORY OF LONG QT SYNDROME, OR CONCOMITANT MEDICATIONS KNOWN TO PROLONG QT INTERVAL.
•8. HISTORY OF HIV INFECTION, INCLIDING A PSOTIVE HIV TEST RESULT (ELISA AND WESTERN BLOT). AN HIV TEST WILL NOT BE REQUIRED, HOWEVER, PREVIOUS MEDIACL HISTORY WILL BE REVIEWED.
•9. PATIENTS WITH CUSHING´S SYNDROME DUE TO ECTOPIC ACTH SECRETION.
•10. PATIENTS WITH HYPERCORTISOLISM SECONDARY TO ADRENAL TUMORS OR NODULAR (PRIMARY) BILATERAL ADRENAL HYPERPLASIA.
•11. PATIENTS WHO HAVE A KNOWN INHERITED SYNDROME AS THE CAUSE FOR HORMONE OVER SECRETION

发起方

OVARTIS BIOSCIENSES PERU S.A.,