EUCTR2019-002190-66-PL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
- •Main part of the trial:
- •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 =2.0xULN at screening (adjusted for age and sex; mean value of the first measurement at screening and the second measurement at 2 weeks before Day 1)
- •IGF-1 levels <=1xULN at screening (adjusted for age and sex; value of the first measurement at
- •screening and the second measurement at 2 weeks before Day 1) either without prior pituitary radiotherapy or with prior pituitary radiotherapy
- •Adequate liver, pancreatic, renal and bone marrow functions
- •Extension Part of the Trial:
- •Continuation Criteria for Patients who Continue Directly to the Extension Part of the Trial
- •Patients who continue directly from the main part of the trial must complete treatment with CAM2029 in the main part of the trial, attend the Week 52 visit, and provide written informed consent to continue treatment in the extension part of the trial before treatment can be continued.
- •Main Inclusion Criteria for Re-invited Patients:
- •Completed treatment with CAM2029 in the main part of the trial and attended the Week 52 visit
- •Adequate liver, pancreatic and renal functions
- •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
- •Main part of the trial:
- •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 prior to 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 [HbA1c] >8.0%)
- •Main Exclusion Criteria for Re-invited Patients -Extension Part of the Trial:
- •Receiving treatments (other than treatments for acromegaly) known to affect GH or IGF-1
- •concentration
- •Patients who have undergone major surgery/surgical therapy (including pituitary surgery) for
- •any cause within 1 month prior to screening
- •Patients who have received pituitary irradiation since the end of the main part of the trial
- •Patients with poorly controlled diabetes mellitus (HbA1c >8.0%)
研究者
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