SWEGHO - A PROSPECTIVE NON INTERVENTIONAL STUDY PROTOCOL WITH PRIMARY DATA COLLECTION - ASSESSMENT OF THE LONG TERM TREATMENT OUTCOMES OF GENOTROPIN TREATMENT IN GHD PATIENTS IN SWEDEN
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 377
- 试验地点
- 12
- 主要终点
- Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments
研究概览
简要总结
The purpose of this study is to assess the long term treatment outcomes of Growth Hormone treatment in patients who are prescribed and treated with Genotropin. Also, plan to determine the relationships between clinical status, dosage schedule and response to Genotropin treatment.
This study will also contribute to our knowledge of adult Growth Hormone Deficiency, including transition period in Childhood Onset Growth Hormone Deficiency and its treatment.
详细描述
Patients within inclusion criteria are asked to participate in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 of 18 years of age and above and fulfilling one of the three alternatives a-c below;
- •Newly diagnosed with GHD according to the current medical standard.
- •Diagnosed with GHD before 2013 and previously treated with Genotropin and followed in KIMS®.
- •Transition patients diagnosed with CO-GHD before
- •Prescribed Genotropin at the time of inclusion.
- •Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
排除标准
- •Patients who participate in any concurrent clinical interventional trial where a non-authorized or authorized study medication is used, during their participation in Swedish KIMS® Xtended. Concurrent studies which do not include any study interventional items (whether medications or devices) are allowed.
结局指标
主要结局
Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments
时间窗: Up to 5 years (after baseline visit)
IGF-I along with growth hormone helps promote normal bone and tissue growth and development. Categories for assessment for participant's post-baseline IGF-I values: (1) IGF-I LLN = if any of assessments of IGF-I post-baseline visit was lower than lower limit of normal (LLN); (2) IGF-I ULN = If any of assessments of IGF-I post-baseline visit was greater than upper level of normal (ULN); (3) IGF-I unknown = no IGF-I reported; (4) Within reference range = IGF-I levels within normal range. Following is normal reference range of IGF-I in nanogram per milliliter. 18 Years of age (Y): Male =162-541, Female =170-640; 19 Y: Male =138-442, Female =147-527; 20 Y: Male =122-384,Female =132-457; 21-25 Y=116-341; 26-30 Y=117-321; 31-35 Y=113-297; 36-40 Y=106-277; 41-45 Y =98-261; 46-50 Y=91-246; 51-55 Y=84-233; 56-60 Y=78-220; 61-65 Y=72-207; 66-70 Y=67-195; 71-75 Y=62-184; 76-80 Y=57-172; \>80 Y=53-162. There was no differentiation for male and female in normal range of IGF-I after 20 years of age.
次要结局
- Height of Participants at Baseline, Years 1, 2, 3, 4 and 5(Baseline, Year 1, 2, 3, 4, 5)
- Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5(Baseline, Year 1, 2, 3, 4, 5)
- Number of Treatment Related Adverse Events(Baseline up to 5 years)
- Number of Participants Who Discontinued Study Due to Adverse Events(Baseline up to 5 years)
- Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5(Baseline, Year 1, 2, 3, 4, 5)
- Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline up to 5 years)
- Number of Adverse Events Leading to Withdrawal of Genotropin Treatment(Baseline up to 5 years)
- Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5(Baseline, Year 1, 2, 3, 4, 5)
- Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5(Baseline, Year 1, 2, 3, 4, 5)
- Percentage of Participants With Any Change From Baseline in Hormone Abnormalities at Years 1, 2, 3, and 4(Baseline, Year 1, 2, 3, 4)
- Percentage of Participants With Any Concomitant Medication at Baseline and During Follow-up(Baseline, Follow-up (during 28 days after last dose of Genotropin treatment))
- Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5(Baseline, Year 1, 2, 3, 4, 5)
- Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5(Baseline, Year 1, 2, 3, 4, 5)
- Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5(Baseline, Year 1, 2, 3, 4, 5)
- Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5(Baseline, Year 1, 2, 3, 4, 5)
- Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5(Baseline, Year 1, 2, 3, 4, 5)
- Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4(Baseline, Year 1, 2, 3, 4)
- Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5(Baseline, Year 1, 2, 3, 4, 5)