A Phase 3, randomized, double-blind, placebo-controlled, multi-center trial to assess efficacy and safety of octreotide subcutaneous depot (CAM2029) in patients with acromegaly

Camurus AB0 个研究点目标入组 78 人开始时间: 2019年6月21日最近更新: 2020年5月25日

适应症

试验速览

暂无简介。

•- Male or female patients, =18 years at screening
•- Able to provide written informed consent to participate in the trial prior to any trial related procedures are performed
•- 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 at screening
•- Adequate liver, pancreatic, renal and bone marrow functions
•- Normal ECG
•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 70
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 8

•- GH =2.5 µg/L at screening (cycle)
•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
•Patients with poorly controlled diabetes mellitus (hemoglobin A1c >8.0%)

发起方