Title for SCGAM-03: CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES WHO HAVE COMPLETED THE SCGAM-01 TRIAL Title for SCGAM-03 in Canada: CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Octapharma
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Creatinine
研究概览
简要总结
Summary for SCGAM-03: Clinical phase III study to monitor the safety, tolerability and efficacy of subcutaneous human immunoglobulin (Octanorm) in patients with primary immunodeficiency diseases who have completed the SCGAM-01 trial.
Summary for SCGAM-03 in Canada: Clinical phase III study to monitor the safety, tolerability and efficacy of subcutaneous human immunoglobulin (octanorm) in patients with primary immunodeficiency diseases, including (but not limited to) those who have completed the SCGAM-01 trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Octanorm 16.5%
octanorm 16.5%, human normal immunoglobulin for subcutaneous (SC) administration.
干预措施: Octanorm 16.5% (Drug)
结局指标
主要结局
Creatinine
时间窗: From study start to end, up to 3.5 years
Changes in creatinine from baseline to end of study
Occurrence of Temporally Associated TEAEs
时间窗: From study start to end, up to 3.5 years
Blood Glucose
时间窗: From study start to end, up to 3.5 years
Changes in blood glucose from baseline to end of study
ALAT
时间窗: From study start to end, up to 3.5 years
Changes in ALAT (alanine transaminase) from baseline to end of study
Number of Participants With a Change in Urine Glucose
时间窗: From study start to end, up to 3.5 years
Number of Participants with a Change in Urine Glucose
Sodium
时间窗: From study start to end, up to 3.5 years
Changes in sodium levels from baseline to end of study
Number of Participants With a Change in Urine Leukocytes
时间窗: From study start to end, up to 3.5 years
Number of participants with a change in urine leukocytes at baseline and end of study
Haemoglobin
时间窗: From study start to end, up to 3.5 years
Changes in haemoglobin from baseline to end of study
Total Bilirubin
时间窗: From study start to end, up to 3.5 years
Changes in total bilirubin from baseline to end of study
Occurrence of All Treatment-emergent Adverse Events (TEAEs)
时间窗: From study start to end, up to 3.5 years
Number of TEAEs
Respiratory Rate
时间窗: From study start to end, up to 3.5 years
ASAT
时间窗: From study start to end, up to 3.5 years
Changes in ASAT (aspartate aminotransferase) from baseline to end of study
Haematocrit
时间窗: From study start to end, up to 3.5 years
Changes in haematocrit from baseline to end of study
Number of Temporally Associated TEAEs by Infusion Rate
时间窗: From study start to end, up to 3.5 years
Number of temporally associated TEAEs by infusion rate. Only includes systemic TEAEs without infections and without infusion site reactions
Blood Pressure
时间窗: From study start to end, up to 3.5 years
Systolic and diastolic.
Potassium
时间窗: From study start to end, up to 3.5 years
Changes in potassium levels from baseline to end of study
Local Injection-site Reactions
时间窗: From study start to end, up to 3.5 years
Body Temperature
时间窗: From study start to end, up to 3.5 years
LDH
时间窗: From study start to end, up to 3.5 years
Changes in LDH (lactate dehydrogenase) from baseline to end of study
Blood Urea Nitrogen
时间窗: From study start to end, up to 3.5 years
Changes in blood urea nitrogen from baseline to end of study
Urine pH
时间窗: From study start to end, up to 3.5 years
Changes in urine pH from baseline to end of study
Number of Participants With a Change in Urine Hemoglobin
时间窗: From study start to end, up to 3.5 years
Number of participants with a change in urine hemoglobin at baseline and end of study
Number of Participants With a Change in Urine Ketones
时间窗: From study start to end, up to 3.5 years
Number of Participants With a Change in Urine Ketones at baseline and end of study
Complete Red Blood Cell Count
时间窗: From study start to end, up to 3.5 years
Changes in complete red blood cell count from baseline to end of study
Complete White Blood Cell Count
时间窗: From study start to end, up to 3.5 years
Changes in complete white blood cell count from baseline to end of study
次要结局
- Number of Participants With Serious Bacterial Infections (SBIs).(From study start to end, up to 3.5 years)
- Measurement of Trough Total IgG Levels(From study start to end, up to 3.5 years)
- SF-36 Health Survey.(From study start to end, up to 3.5 years)
- CHQ-PF50 (Child Health Questionnaire-Parent Form)(From study start to end, up to 3.5 years)