NCT02396966已完成不适用
A Prospective, Non-interventional, Observational, Multi-centre Study to Document QoL of Subjects With Acromegaly Under Lanreotide Autogel® Treatment.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 152
- 主要终点
- Acromegaly quality of life (AcroQol) questionnaire
研究概览
简要总结
The purpose of the protocol is to evaluate and describe QoL, in the population of Polish acromegalic patients treated with Lanreotide Autogel® 120 mg during the 24 months (long term observation).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with acromegaly treated for at least three months and no longer than three years with Lanreotide Autogel® 120 mg just before inclusion.
- •Patients capable of giving their informed consent to participate in the study and who agree to participate by signing the informed consent form.
排除标准
- •Active participation in any interventional or any other non-interventional acromegaly clinical study. (Previous participation in any interventional or any observational / post marketing study (PMS) of other somatostatin analogue should not be an exclusion criteria).
- •Any medical or psychological condition, according to investigator judgement, that might compromise the ability to give informed consent.
结局指标
主要结局
Acromegaly quality of life (AcroQol) questionnaire
时间窗: Change from baseline (visit 1), visit 3 and 6 (visits occur approximately every 4-5 months, during 2 years of observation)
The AcroQol questionnaire and total AcroQol score will be analysed descriptively overall and according to hormonal control, presence of prior radiotherapy, presence of prior surgery.
次要结局
- Clinical symptoms of acromegaly(Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation))
- Lanreotide injection interval (28, 42 or 56 days)(Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation))
- Hormonal control of serum growth hormone (GH) and insulin-like growth factor 1 (IGF-1) concentration(Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation))
- Patient overall assessment of satisfaction from treatment(Visit 1 to 6 (visits occur approximately every 4-5 months, during 2 years of observation))
研究者
相似试验
已完成
不适用
NEXThaleR Real-world Study Assessing the EffectivenesS of BDP/FF/G Fixed triPle cOmbiNation on Symptom scorEs in COPD PatientsCOPDNCT05743608Chiesi Hungary Ltd.1,336
招募中
不适用
Angelman Syndrome Natural History Study-FAST UKAngelman SyndromeNCT05100810University of Oxford40
招募中
不适用
Baker Gordon Syndrome Natural History StudyRare DiseasesAutism or Autistic TraitsDevelopment DelaySYT-SSX Fusion Protein ExpressionSleep DisorderEpilepsy, GeneralizedMotor DelayNCT06399952University of Missouri-Columbia50
已完成
不适用
Myelofibrosis and Essential Thrombocythemia Observational Study (MOST)MPN (Myeloproliferative Neoplasms)NCT02953704Incyte Corporation1,469
已完成
不适用
An Observational Study to Assess the Quality of Life of the Patients With Multiple Sclerosis and Their CaregiversMultiple SclerosisNCT01075737Merck KGaA, Darmstadt, Germany141