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 - A Phase 3 trial to assess the long term safety of octreotide subcutaneous depot in patients with acr

Camurus AB0 个研究点目标入组 140 人开始时间: 2021年1月13日最近更新: 2021年1月18日

研究概览

暂无简介。

•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

•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%)

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