An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease (Seascape).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 18
- 主要终点
- Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE)
研究概览
简要总结
This study provided access to pasireotide sc in patients with Cushing's disease.and provided additional information for safety and efficacy of pasireotide s.c.
详细描述
Purpose of this study was to give access to pasireotide sc for patients with Cushing's disease as no medical treatment for Cushing's disease was approved at the time of the study initiation. The study population consisted of patients with persistent or recurrent Cushing's disease or patients with de novo Cushing's disease that were not considered candidates for pituitary surgery (poor surgery candidates, surgically unapproachable tumor, patients with no visible pituitary tumor, patients who refused surgery). A confirmed Cushing's disease diagnosis was required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pasireotide 600 μg
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 600 μg bid group includes all patients whose mean daily dose < 1500 μg /day.
干预措施: Pasireotide sub-cutaneous (Drug)
Pasireotide 900 μg
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
干预措施: Pasireotide sub-cutaneous (Drug)
结局指标
主要结局
Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE)
时间窗: Baseline up to approximately 256 weeks
Only AEs occurring on or after the start of study treatment and no more than 28 days after the discontinuation of study treatment. A patient with multiple occurrences of an AE under one treatment is counted only once in the AE category for that treatment. A patient with multiple severity grades for an AE while on a treatment, is only counted under the maximum grade.
次要结局
- Percent Change in Cushing's Disease Clinical Signs and Symptoms - Pulse(Baseline, week 12, 24 and 48)
- Percent Change in Cushing's Disease Clinical Signs and Symptoms - Temperature(Baseline week 12, 24 and 48)
- Percent Change in Cushing's Disease Clinical Signs and Symptoms - Muscle Strength(Baseline, week 12, 24 and 48)
- Percent Change From Baseline in Insulin Growth Factor - 1 (IGF - 1) Values(Baseline, week 12, 24 and 48)
- Percent Change in Cushing Quality of Life and Work Productivity and Activity Impairment-General Health (WPAI-GH) Scores(Baseline, week 12, 24 and 48)
- Percent Change in Cushing's Disease Clinical Signs and Symptoms - Body Mass Index (BMI)(Baseline, week 12, 24 and 48)
- Percent Change in Cushing's Disease Clinical Signs and Symptoms - Waist Circumference(Baseline, week 12, 24 and 48)
- Percentage of Patients With Mean Urinary Free Cortisol (UFC) ≤ Upper Limit of Normal (ULN)(Baseline, week 12, 24 and 48)
- Percent Change in Cushing's Disease Clinical Signs and Symptoms - Blood Pressure (BP)(Baseline, week 12, 24 and 48)
- Percent Change in Cushing's Disease Clinical Signs and Symptoms - Weight(Baseline, week 12, 24 and 48)
- Percent Change From Baseline in Growth Hormone (GH) Values(Baseline, week 12, 24 and 48)
- Percentage of Patients Achieving a Reduction of Mean UFC ≥ 50% From Baseline(Baseline, week 12, 24 and 48)
- Percent Change in Cushing's Disease Clinical Signs and Symptoms - Hirsutism(Baseline, week 12, 24 and 48)