EUCTR2005-005852-42-BE进行中（未招募）1 期
An open-label, two-step, multicenter European study to evaluate the efficacy and safety of Sandostatin LAR at High Dose or in combination either with GH-receptor antagonist or dopamine-agonist in acromegalic patients not adequately controlled by conventional regimen - HOSCAR
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Male or female patients aged >= 18 years
- •- Patient with biochemically documented active acromegaly, not adequately controlled by conventional regimen, as follows: mean 1-h GH > 2.5 µg/L, according to Central Laboratory and IGF-I above the upper limit of normal range, adjusted for age and gender, according to Central Laboratory range. Both tests should be documented by Central Laboratories and not older than 4 weeks from entry
- •- Patient has been receiving SSA at conventional regimen for at least 6 months prior to entry (Note : for the purpose of this study, the definition of SSA at conventional regimen is : Sandostatin LAR (octreotide) at 30 mg every 28 days or Autogel (lanreotide) at 120 mg every 28 days)
- •- Patient with the reduction of either mean fasting GH at least 50% or IGF-I at least 25% from any medical pretreatment level
- •- Patient with diagnosis of pituitary micro- or macroadenoma and independently from previous surgery
- •- Written voluntary 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Newly diagnosed or previously medically untreated acromegalic patient
- •- Concomitant treatment with GH-receptor antagonist (Note : prior treatment with GH-antagonist is allowed providing a wash-out period of at least 8 weeks before inclusion)
- •- Concomitant treatment with dopamine-agonist (Note : prior treatment with dopamine-agonist is allowed providing a wash-out period of at least 6 weeks before inclusion)
- •- Symptomatic cholelithiasis or choledocolithiasis
- •- Liver transaminases (ALT, AST) elevated, but >= 3 times upper normal limit (according to local laboratory)
- •- Previous gamma-knife radiotherapy for treatment of acromegaly (Note : previous conventional radiotherapy is allowed providing that it was stopped at least 3 weeks before inclusion)
- •- Compression of the optic chiasm causing visual field defect
- •- Known hypersensitivity to any of the study drugs or to drugs with similar chemical structures
- •- Any medical conditions contraindicated in the Summary of Product Characteristic (SPC) of all study drugs
- •- Any current or prior medical condition that, in the judgment of the Investigator, may interfere with the conduct of the study or the evaluation of the study results.
- •- Female patients who are pregnant or lactating or are of childbearing potential and not practicing a medically acceptable method for birth control.
- •- Participation in investigational drug study within 30 days before inclusion. Patient must have recovered from all side effects of other investigational therapy
- •- History of non-compliance to medical regimens, or patient who is considered potentially unreliable, or any circumstance at the time of study inclusion that would preclude completion of the entire study or the required follow up
研究者
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