Lanreotide Autogel-120 mg as First-Line Treatment of Acromegaly
关键词
抽象
描述
This is an open, prospective, observational, clinical study to be performed in two University Hospitals (Naples and Genova, Italy). The primary objective is to evaluate the efficacy of the ATG 120 mg on control of GH and IGF-I excess in acromegaly according with the currently accepted criteria (12) and on tumor shrinkage. The secondary objectives are to assess improvement of clinical symptoms and safety profile. The study population will consist of at least 20 patients, enrolled in the two centers from Jan 1st 2003 to June 30th 2007. Patients give their written informed consent prior to entering into the study. The study was performed according to the principles defined by the declaration The safety population, as defined by the protocol, consists of patients who received at least one study drug dosing.
Hormonal evaluation GH levels are assessed as a mean value of 5 samples at 30-min intervals (starting between 08:00 and 9:00 in the morning) taken at each visit before the injection of ATG. IGF-I levels are assessed as a single sample taken at each visit at the same time as the first GH sample. All hormonal parameters were assessed in a central laboratory (University of Genoa).
Improvement in clinical symptoms is considered on the basis of a semiquantitative scale for asthenia, hyperhidrosis, headache, swelling of extremities, arthralgia, paraesthesia, carpal tunnel syndrome: symptoms were graded as 0 = absent, 1 = mild, 2 = moderate, 3 = severe.
Any adverse event (AE) during the study is monitored and reported by the investigators. Safety, evaluated by local laboratory data, is assessed at inclusion and at the final visit by: hematology: erythrocytes, leukocytes, platelets, haemoglobin, hematocrit; biochemistry: glucose, creatinine, alkaline phosphatase, total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), electrolytes (sodium, potassium, calcium, phosphorous) glycosylated haemoglobin, triglycerides, total and high density lipoproteins (HDL) cholesterol, blood amylase, iron, transferrin, prothrombin; glucose and insulin concentrations; hormonal evaluation: thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), free triiodothyronine (FT4), follicle stimulating hormone (FSH) and luteinizing hormone (LH) levels. Safety related to gallbladder is assessed by ultrasound examination performed at inclusion and at the end of the study.
日期
| 最后验证: | 11/30/2007 |
| 首次提交: | 02/21/2008 |
| 提交的预估入学人数: | 02/21/2008 |
| 首次发布: | 03/02/2008 |
| 上次提交的更新: | 02/21/2008 |
| 最近更新发布: | 03/02/2008 |
| 实际学习开始日期: | 12/31/2002 |
| 预计主要完成日期: | 11/30/2007 |
| 预计完成日期: | 11/30/2007 |
状况或疾病
干预/治疗
Drug: A
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: A Newly diagnosed patients with acromegaly | Drug: A ATG120 mg is given as deep subcutaneous injection into the buttock. Each patient receives one deep subcutaneous injection of ATG120 mg at Visit 1 (V1) and subsequent injection every 4 weeks for 3 injections. Based on GH levels, the dosing interval has been determined as follows: if GH levels were > 2.5 mcg/l, ATG 120 mg is given every 4 weeks while if they were < 2.5 mcg/l ATG 120 mg is administered every 6 weeks for another 3 injections. Afterwards, the dose is maintained as above except in patients with GH levels <1 mcg/l receiving ATG 120 mg every 8 weeks. The estimated duration of treatment is 48-52 weeks according with dose titration. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Patients with active acromegaly [serum GH levels above 2.5 μg/liter and/or above 1 μg/liter after oral glucose tolerance test (OGTT) and abnormal IGF-I values] with a micro- (<10 mm max tumor diameter) or macroadenoma (>10 mm max tumor diameter) - Patients never treated before - Patients who do not require immediate surgery because of neurological symptoms and/or emergency conditions - Patients who signed an informed consent to participate to the study. Exclusion Criteria: - Patients already treated before with surgery or radiotherapy or with medical treatment - Patients with mixed GH-PRL adenomas who require combined somatostatin and dopamine treatment |
结果
主要结果指标
1. Control of GH and IGF-I excess and tumor shrinkage [3 and 12 months]
次要成果指标
1. Improvement of clinical symptoms and safety profile [3 and 12 months]
