NCT04125836已完成3 期
A Phase 3, Open-label, Single-arm, Multi-center Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Camurus AB
- 入组人数
- 135
- 试验地点
- 67
- 主要终点
- Characterization of adverse events (AEs)
研究概览
简要总结
The purpose of this trial is to assess the long-term safety and efficacy of CAM2029 in patients with acromegaly. Patients will be administered CAM2029 subcutaneously once monthly during 12 months. Patients fulfilling trial NCT04076462 will be offered to continue with open-label treatment week 24-52 in this trial. Patients completing the main part of the trial will be offered 52 weeks continued open-label treatment in an extension part.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Male or female patients, ≥18 years at screening
- •Able to provide written informed consent to participate in the trial
- •Diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly
- •Treatment with a stable dose of octreotide LAR or lanreotide ATG for at least 3 months as monotherapy prior to screening
- •IGF-1 levels ˃1xULN and ≤2.0xULN at screening or IGF-1 levels ≤1xULN at screening with or without prior pituitary radiotherapy
- •Adequate liver, pancreatic, renal and bone marrow functions
- •Normal ECG
排除标准
- •For Roll-over Patients from NCT04076462:
- •Unresolved, drug-related serious adverse event (SAE) from the preceding trial
- •Patients with a clinically significant or unstable medical or surgical condition that may preclude safe and complete trial participation
- •For New Patients:
- •Have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening [whichever is longer]
- •Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)
- •Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated
- •Patients who have undergone major surgery/surgical therapy for any cause within 1 month from screening
- •Patients who have undergone pituitary surgery within 6 months prior to screening
- •Patients who have received prior pituitary irradiation within 3 years prior to screening
- •Patients with poorly controlled diabetes mellitus (hemoglobin A1c >8.0%)
研究组 & 干预措施
CAM2029 (octreotide subcutaneous depot)
Experimental
CAM2029 (octreotide subcutaneous depot) 20mg/1.0 mL for 20 mg dose, subcutaneous injection once monthly, 12 months treatment with an option of extension. If down-titration is required, 10mg/0.5 mL for 10 mg dose is available.
干预措施: CAM2029 (octreotide subcutaneous depot) (Drug)
结局指标
主要结局
Characterization of adverse events (AEs)
时间窗: Week 0-52
次要结局
- Proportion of patients with mean IGF-1 levels ≤1xULN and <1.3xULN(Week 50 to 52)
- Proportion of patients with mean GH levels <2.5 µg/L and <5.0 µg/L(Week 50 to 52)
- Proportion of patients/partners declared competent by a healthcare professional to administer intervention(Week 0-52)
- Octreotide plasma concentrations over time(Week 0-52)
研究者
研究点 (67)
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