NL-OMON39251已完成3 期
A randomized, double-blind, multicenter, phase III study to evaluate the efficacy and safety of pasireotide LAR in patients with Cushing*s disease - CSOM230G2304
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •2. Adult patients with confirmed diagnosis of ACTH-dependant Cushing*s disease
- •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)
- •4. Confirmation that pseudo-Cushing*s is excluded for patients with mUFC * 3 x ULN
- •6. Karnofsky performance status * 60 (i.e. requires occasional assistance, but is able to care for most of their personal needs)
- •7. For patients on medical treatment for Cushing*s disease the washout periods must be completed before screening assessments are performed
- •8. Patients with a known history of impaired fasting glucose or DM may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the study and adjusted as necessary.
排除标准
- •1. Patients who are considered candidates for surgical treatment at the time of study entry
- •2. Patients who have received pituitary irradiation 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 last 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, including a positive HIV test result (Elisa and Western blot). An HIV test will not be required, however, previous medical 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 (i.e. Carney Complex, McCune-Albright syndrome, MEN-1)
- •12. Patients with a diagnosis of glucocorticoid-remedial aldosteronism (GRA)
- •13. Patients who are hypothyroid and have clinical symptoms of hypothyroidism despite adequate replacement therapy
- •14. Patients who have undergone major surgery within 1 month prior to starting the study
- •15. Patients with symptomatic cholelithiasis
- •16. Patients with abnormal coagulation (PT or PTT elevated by 30% above normal limits)
- •17. Patients receiving anticoagulants that affect PT or PTT
- •18. Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, clinically significant bradycardia, advanced heart block, history of acute MI less than one year prior to study entry or clinically significant impairment in cardiovascular function
- •19. Patients with history of liver disease such as cirrhosis, chronic active hepatitis B and C, or patients with ALT/AST more than 2 X ULN, serum bilirubin >1.5 X ULN
- •20. Patients with serum creatinine >2.0 X ULN,
- •21. Patients with WBC >3 X 109/L; Hgb 90% > LLN; PLT >100 X 109/L
- •31. Presence of Hepatitis B surface antigen (HbsAg)
- •32. Presence of Hepatitis C antibody (anti-HCV)
- •33. Known gallbladder or bile duct disease, acute or chronic pancreatitis
研究者
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