NCT01995734Approved For Marketing不适用
An ACromegaly, Open-label, Multi-CEnter, Safety Monitoring Program for Treating Patients With SOM230 (Pasireotide) LAR Who Have Need to Receive Medical Therapy (ACCESS)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
- 试验地点
- 37
研究概览
简要总结
The present study is planned as an expanded treatment protocol to provide acromegalic patients for whom medical therapy is appropriate access to pasireotide LAR while regulatory approval for pasireotide is sought.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed diagnosis of active acromegaly with elevated IGF-1 (>ULN) and random GH (>1 μg/L) within 30 days of screening.
- •Patients who are not controlled by pituitary surgery or who are not eligible for or refuse surgery.
- •For patients on medical treatment for acromegaly the following washout periods must be completed before screening assessments are performed:
- •Dopamine agonists (bromocriptine, cabergoline): 4 weeks
- •GH-receptor antagonists (pegvisomant): 8 weeks
- •Somatostatin analogues: no washout period required
- •Karnofsky performance status ≥ 60.
排除标准
- •Concomitant treatment with somatostatin analogues unless concomitant treatment was discontinued 28 days before first pasireotide LAR injection is administrated.
- •Concomitant treatment with growth hormone receptor (GHR)-antagonists or dopamine agonists unless concomitant treatment was discontinued and the washout period was completed before the screening assessments are performed.
- •Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated.
- •Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression.
- •Patients who have undergone major surgery/surgical therapy for any cause within 4 weeks of screening.
- •Patients who have received radiotherapy of the pituitary within 4 weeks prior to screening or have not recovered from side effects of radiotherapy.
- •Patients who have a history of hypothyroidism and who are not adequately treated with stable doses of thyroid hormone replacement therapy.
- •Patients with active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix).
- •Diabetic patients whose blood glucose is poorly controlled.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究者
研究点 (37)
Loading locations...
相似试验
已完成
4 期
Somatuline Autogel: Acromegaly Self/Partner Injection StudyAcromegalyNCT00149188Ipsen30
已完成
2 期
Phase II Study With ITF2984 in Acromegalic PatientsAcromegalyNCT02111044Italfarmaco48
已完成
3 期
Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With AcromegalyAcromegalyNCT00225979Novartis Pharmaceuticals100
已完成
3 期
A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With AcromegalyAcromegalyNCT04076462Camurus AB72
已完成
不适用
Predictive Factors of Response to Somatostatin Analogues in Acromegalic Patients With Persistent Disease Following SurgeryAcromegalyNCT00500227Ipsen55