Long-term Safety Follow-up After Growth Hormone Treatment (rhGH) of Short Children Born Small for Gestational Age (SGA)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Sandoz
- 入组人数
- 130
- 试验地点
- 24
- 主要终点
- Evaluate the Long-term Effect of Growth Hormone Treatment on the Development of Diabetes After End of Therapy.
研究概览
简要总结
This study is performed as part of the Marketing Authorisation Holder's post-marketing pharmacovigilance plan to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).
详细描述
The purpose of this study is
- to monitor short children born SGA who were treated with growth hormone in study EP00-401 for the development of diabetes for a further 10 years after termination of growth hormone treatment
and 2. to report the incidence of anti-rhGH antibodies and of E. coli host cell peptide (HCP) antibodies (ABs) for 6 months after termination of GH treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who fulfilled the diagnosis SGA, participated in study EP00-401, and received at least one dose of study medication
- •Written informed consent of patient (for children who can read and/ or understand) and/or parent or legal guardian
排除标准
- •Patients unwilling and/or parents/guardians who are not capable of ensuring compliance with the provisions of the study protocol
研究组 & 干预措施
Monitoring of long-term safety
Long-term safety follow-up after the end of treatment with Omnitrope (single arm)
干预措施: Bloodsampling (Other)
结局指标
主要结局
Evaluate the Long-term Effect of Growth Hormone Treatment on the Development of Diabetes After End of Therapy.
时间窗: 5 years
Number of participants diagnosed with Diabetes mellitus type 2 during the study, defined as fullfilment of these 3 criteria: * FPG ≥ 126 mg/dl (7.0 mmol/L) during blood sampling and/or during Oral Glucose Tolerance Test (OGTT) * 2-h plasma glucose ≥ 200 mg/dl (11.1 mmol/L) during an OGTT * Investigator documenting diagnosis of diabetes mellitus type 2 during OGTT
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Fasting Plasma Glucose (FPG) Levels
时间窗: baseline, 6 months, 1 year, 5 years
Supportive to Primary Endpoint
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Fasting Insulin Levels
时间窗: baseline, 6 months, 1 year, 5 years
Supportive to Primary Endpoint
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Glucose Glycolsylated Hemoglobin (HbA1c)
时间窗: baseline, 6 months, 1 year, 5 years
Supportive to Primary Endpoint
To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through HOMA and QUICKI Scores
时间窗: baseline, 6 months, 1 year, 5 years
Supportive to Primary Endpoint. HOMA = homeostasis model assessment for Insulin resistance: Healthy Range: 1.0 (0.5-1.4). \< 1.0 means you are insulin-sensitive which is optimal. \>1.9 indicates early insulin resistance. \> 2.9 indicates significant insulin resistance. The quantitative insulin sensitivity check index (QUICKI) measures insulin sensitivity, which is the inverse of insulin resistance. The QUICKI calculation for insulin resistance in humans fall broadly within a range between 0.45 for unusually healthy individuals and 0.30 in diabetics. Lower numbers reflect greater insulin resistance.
次要结局
- to Evaluate IGF-I and IGFBP-3 Levels After End of Growth Hormone Treatment(baseline, 6 months, 1 year , 5 years)
- To Evaluate the Incidence of Anti-rhGH Antibodies After Termination of Growth Hormone Treatment.(baseline, 6 months, 1 year, 5 years)
- to Evaluate Final Height(baseline, 6 months, 1 year, 5 years)