CTIS2024-510667-33-00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 - HS-19-647
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
- 86
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Main part of the trail: Male or female patients > =18 years at screening, Main part of the trail: Able to provide written informed consent to participate in the trial, Main part of the trail: Diagnosis of acromegaly by historical evidence (persistent or recurrent) acromegaly, Main part of the trail: Treatment with a stable dose of octreotide LAR or lanreotide ATG for at least 3 months as monotherapy prior to screening, Main part of the trail: 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) or 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, Main part of the trail: Adequate liver, pancreatic, renal and bone marrow functions, Main part of the trail: Normal ECG, 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., Extension part of the trial: 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. Normal ECG.
排除标准
- •Main part of the trail: For roll-over patients from trial HS-18-633: Unresolved, drug-related serious adverse event (SAE) from the preceding trial (HS-18-633), 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%)., Main part of the trail: For roll-over patients from trial HS-18-633: Patients with a clinically significant or unstable medical or surgical condition that may preclude safe and complete trial participation, Main part of the trail: 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]), Main part of the trail: For new patients: Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks), Main part of the trail: For new patients: Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated, Main part of the trail: For new patients: Patients who have undergone major surgery/surgical therapy for any cause within 1 month prior to screening, Main part of the trail: For new patients: Patients who have undergone pituitary surgery within 6 months prior to screening, Main part of the trail: For new patients: Patients who have received prior pituitary irradiation within 3 years prior to screening, Main part of the trail: For new patients: Patients with poorly controlled diabetes mellitus (hemoglobin A1c [HbA1c] >8.0%)
研究者
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