EUCTR2019-002190-66-ES进行中（未招募）1 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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Camurus AB
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 (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 =1.3xULN at screening or IGF-1 levels <=1xULN at screnning with prior pituitary radiotherapy
- •Adequate liver, pancreatic, renal and bone marrow f unctions
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 124
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •For Roll-over Patients from Trial HS-18-633:
- •Unresolved, drug-related serious adverse event (SAE) from the preceding trial (HS-18-633)
- •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%)
研究者
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