NCT02311894已完成4 期
A Phase IV, Multicenter, Open-Label Study of the Immunogenicity of Nutropin AQ® V1.1 [Somatropin (rDNA Origin) Injection] Administered Daily to Naïve Growth Hormone-Deficient Children (iSTUDY)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 33
- 主要终点
- Percentage of Participants Who Develop Anti-GH Antibodies After Treatment With Nutropin AQ v1.1
研究概览
简要总结
This is a Phase IV, multicenter, open-label, single-arm study of somatropin (rDNA origin) (Nutropin AQ v1.1) in pre-pubertal children with growth hormone deficiency (GHD) naïve to prior recombinant human growth hormone (rhGH) treatment. The study is designed to characterize the immunogenicity profile of somatropin (rDNA origin) injection when administered daily subcutaneously for 12 months. The clinical impact of immunogenicity will also be assessed.
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
- 3 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bone age less than equal to (</=) 9 years (females) or </= 11 years (males) as determined by X-ray of the left hand and wrist using Greulich and Pyle method and obtained within the 12 months prior to enrollment
- •Prepubertal (Tanner I) males and females by physical examination
- •Diagnosis of GHD (stimulated GH less than [<] 10 nanograms per milliliter [ng/mL]) by two standard pharmacologic tests obtained up to 12 months prior to informed consent/assent
- •Normal thyroid function test within the 12 months prior to informed consent/assent
- •Normal complete blood counts within 12 months prior to informed consent/assent
- •Documentation of prior height and weight measurements, with height standard deviation score (SDS) </= 5th percentile for idiopathic isolated GHD participants
排除标准
- •Any previous rhGH treatment
- •Short stature etiologies other than GHD
- •Acute critical illness or uncontrolled chronic illness, which in the opinion of the investigator and medical monitor, would interfere with participation in this study, interpretation of the data, or pose a risk to participant safety
- •Chronic illnesses such as inflammatory bowel disease, celiac disease, heart disease, and diabetes
- •Bone diseases such as achondroplasia or hypochondroplasia, intracranial tumor, irradiation, and traumatic brain injury
- •Participants receiving oral or inhaled chronic corticosteroid therapy (greater than [>] 3 months) for other medical conditions other than central adrenal insufficiency
- •Participants who require higher (2 times or greater than maintenance) doses of corticosteroids for more than 5 days in the 6 months prior to enrollment in the study
- •Participants with active malignancy or any other condition that the investigator believes would pose a significant hazard to the participant if rhGH were initiated
- •Females with Turner syndrome regardless of their GH status
- •Prader-Willi syndrome regardless of GH status
- •Born small for gestational age regardless of GH status
- •Presence of scoliosis requiring monitoring
- •Previous participation in another clinical trial or investigation of GH, treatment for growth failure, or treatment with a biologic agent
- •Participants with closed epiphyses
- •Participants with a known hypersensitivity to somatropin, excipients, or diluent
研究组 & 干预措施
Somatropin
Experimental
Children will receive daily SC injections of somatropin at a dose of up to 0.043 milligrams per kilogram per day (mg/kg/day) for 1 year.
干预措施: Somatropin (Drug)
结局指标
主要结局
Percentage of Participants Who Develop Anti-GH Antibodies After Treatment With Nutropin AQ v1.1
时间窗: Baseline up to 1 year
Participants who were tested positive to anti-GH antibody after initiation of study treatment.
次要结局
- Annualized Growth Velocity at Months 6 and 12 (Change From Baseline)(Months 6, 12)
- Percentage of Participants With Adverse Events(Baseline up to 1 year)
- Percentage of Participants Who Exhibit Functional Growth Attenuation(Baseline up to 1 year)
- Percentage of Participants With Neutralizing Antibodies(Baseline up to 1 year)
- Height Standard Deviation Score (SDS) at Months 6 and 12 (Change From Baseline)(Months 6, 12)
研究者
研究点 (33)
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