Scheme of treatment with high-dose lanreotide in acromegalic patients poorly responsive to treatment with standard doses.

AZIENDA OSPEDALIERA Spedali Civili di Brescia0 个研究点目标入组 30 人开始时间: 2013年3月20日最近更新: 2016年4月11日

适应症

试验速览

暂无简介。

•Age> = 18 years
•Basal GH> = 1 microg / l,
•IGF1> 1.2 x ULN (age and sex)
•Ongoing treatment with lanreotide 120 mg every 4 weeks or octreotide 30 mg every 4 weeks for at least 6 months prior to randomization
•Reduction of GH> = 50% in the course of therapy with LLSSA to standard doses compared to pretreatment values
•Written informed consent
•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 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•Symptomatic cholelithiasis
•Unstable angina, sustained ventricular tachycardia, ventricular fibrillation, or a history of acute myocardial infarction in the 3 months prior to enrollment.
•Liver disorders such as cirrhosis, chronic hepatitis, persistent rise in transaminase levels (AST, ALT, alkaline phosphatase 2 x ULN, total bilirubin 1.5 x ULN) or renal dysfunction (creatinine 1.5 x ULN) evaluated at screening;
•Radiotherapy performed in the 5 years prior to enrollment and surgery for acromegaly performed in the 6 months prior to enrollment
•Pregnant or breast-feeding women and women of childbearing age who do not adopt contraceptive methods. For women enrolled in the study, will require a negative urine pregnancy test at enrollment
•Concomitant treatment with drugs able to modify the secretion of GH or IGF-1, as eg. dopamine agonists and pegvisomant
•History of hypersensitivity to treatment with lanreotide
•At the time of screening, and / or enrollment, adverse events being considered related to treatment with SSA of severity greater than grade 1.

发起方

AZIENDA OSPEDALIERA Spedali Civili di Brescia