NCT03075644已完成3 期
A Multicentre, Randomised, Open-labelled, Parallel-group, Activecontrolled Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events, Including Injection Site Reactions
研究概览
简要总结
This trial is conducted in Asia. The aim of this trial is to evaluate the safety of once weekly dosing of somapacitan (NNC0195-0092) and daily Norditropin® FlexPro® for 52 weeks in previously human growth hormone treated Japanese adults with growth hormone deficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female of at least 18 years of age and not more than 79 years of age at the time of signing informed consent - GHD diagnosed for at least 6 months (defined as 180 days) prior to screening - Treatment with hGH for at least 6 consecutive months (defined as 180 days) at screening - If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 90 days prior to randomisation as judged by the investigator
排除标准
- •Active malignant disease or history of malignancy. Exceptions to this exclusion criterion:1/ Resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision 2/ Subjects with GHD attributed to treatment of intracranial malignant tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years is documented in the subject's medical records - For subjects with surgical removal or debulking of pituitary adenoma or other benign intracranial tumour within the last 5 years:Evidence of growth of pituitary adenoma or other benign intracranial tumour within the last 12 months (defined as below or equal to 365 days) before randomisation. Absence of growth must be documented by two post-surgery magnetic resonance imaging (MRI) scans or CT scans. The most recent MRI or CT scan must be performed below or equal to 9 months (defined as below or equal to 270 days) prior to randomisation
研究组 & 干预措施
Somapacitan
Experimental
干预措施: somapacitan (Drug)
Norditropin
Active Comparator
干预措施: Norditropin (Drug)
结局指标
主要结局
Incidence of Adverse Events, Including Injection Site Reactions
时间窗: Weeks 0-53
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which did not necessarily have a causal relationship with the treatment. Rate of AEs per 100 patient years at risk with onset after the first administration of trial product and up until end of the trial (53 weeks) or 14 days after last trial drug administration, whichever came first, are presented.
次要结局
- Change in Cross-sectional Total Adipose Tissue Compartments(Week 0, week 52)
- Change in FPG(Week -3, week 52)
- Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores(Week 0, week 52)
- Change in Subcutaneous Adipose Tissue Compartments(Week 0, week 52)
- Change in SBP and DBP(Week 0, week 52)
- Change in Pulse(Week 0, week 52)
- Change in Haematology: Mean Corpuscular Volume(Week -3, week 52)
- Change in Haematology: Mean Corpuscular Haemoglobin Concentration(Week -3, week 52)
- Change in Biochemistry: Creatinine, Uric Acid, and Bilirubin (Total)(Week -3, week 52)
- Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT(Week -3, week 52)
- Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total)(Week -3, week 52)
- Change in Fasting Insulin(Week -3, week 52)
- Change in Steady State Beta Cell Function(Week -3, week 52)
- Change in Intra-abdominal or Visceral Adipose Tissue Compartments(Week 0, week 52)
- Change in ECG(Week -3, week 52)
- Change in Physical Examination(Week 0, week 52)
- Change in Body Weight(Week -3, week 52)
- Change in Haematology: Haemoglobin(Week -3, week 52)
- Change in Haematology: Haematocrit(Week -3, week 52)
- Change in Haematology: Thrombocytes, Leucocytes(Week -3, week 52)
- Change in Haematology: Erythrocytes(Week -3, week 52)
- Change in Biochemistry: eGFR Creatinine(Week -3, week 52)
- Change in HbA1c(Week -3, week 52)
- Change in Insulin Resistance(Week -3, week 52)
- Occurrence of Anti-hGH Antibodies(Weeks 0 - 53)
- Incidence of Clinical Technical Complaints(Weeks 0 - 53)
- Change in Biochemistry: Total Protein and Albumin(Week -3, week 52)
- Occurrence of Anti-somapacitan Antibodies(Weeks 0 - 53)
研究者
研究点 (1)
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