The Global Hypopituitary Control and Complications Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,673
- 主要终点
- Clinically Significant Adverse Events
研究概览
简要总结
The Hypopituitary Control and Complications Study "HypoCCS" is a prospective, open label, global, multicentre, observational study on routine clinical care of adults with growth hormone deficiency occurring either isolated or in combination with other pituitary hormone deficiencies. The objective of this observational study is to evaluate long-term safety and health outcomes for adult growth hormone deficient participants with or without somatropin replacement therapy. As an observational study, data are collected only as provided at the discretion of the attending physician. The participant enrolled meet the criteria of growth hormone deficiency in adults as per the Humatrope label in the country where their attending physician practices, and this diagnosis is at the discretion of the attending physician. The decision to receive somatropin or remain untreated is made by the participant in consultation with their attending physician.
While treatment of adult growth hormone deficient participants with somatropin has been shown to be safe and effective in clinical trials of 18 months duration, this observational study aims to provide information on health outcome and replacement therapy over longer periods of time for a larger number of participants in the context of the overall disease environment.
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 growth hormone deficiency as per the local Humatrope label and as judged by the attending physician
排除标准
- •As per the local Humatrope label and as judged by the attending physician
研究组 & 干预措施
Somatropin replacement treatment
Adult participants with growth hormone deficiency receiving somatropin replacement treatment.
干预措施: Somatropin (rDNA origin) (Drug)
结局指标
主要结局
Clinically Significant Adverse Events
时间窗: Baseline to study completion (approximately 10 years)
A summary of all reported serious adverse events (SAE) and other adverse events regardless of causality are provided in the Adverse Events module of this record.
次要结局
- Cardiovascular Risk Factor-Change From Baseline in Cholesterol and Triglycerides(Baseline, interim time point (5 years), and study completion (10 years))
- Percentage of Participants Experiencing a Bone Fracture (Fracture Incidence)(Baseline through 10 years)
- Cardiovascular Risk Factor-Change From Baseline in Body Mass Index (BMI)(Baseline, interim time point (5 years), and study completion (10 years))
- Cardiovascular Risk Factor-Change From Baseline in Systolic (SBP) and Diastolic Blood Pressure (DBP)(Baseline, interim time point (5 years), and study completion (10 years))
- Change From Baseline in the Total Z Score of the Disease-specific Module of the Questions of Life Satisfaction (QLS-H).(Baseline, interim time point (5 years), and study completion (10 years))
- Cardiovascular Risk Factor-Change From Baseline in Waist Circumference(Baseline, interim time point (5 years), and study completion (10 years))