NCT01237340终止3 期
A Phase IIIb, Open-label, Single-arm, Multicenter Study to Assess the Immunogenicity of the Recombinant-Human Growth Hormone (r-hGH) Liquid Multidose Formulation (Saizen® Solution for Injection) When Administered to Male and Female Adults With Documented Growth Hormone Deficiency (GHD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- EMD Serono
- 入组人数
- 59
- 主要终点
- Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen®
研究概览
简要总结
To assess the immunogenicity of Saizen® solution for injection in adult subjects with documented Growth Hormone Deficiency (GHD).
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female subjects, 18-60 years of age, inclusive, at the time the informed consent is signed
- •Subjects who have confirmed adult GHD
- •Subjects who are growth hormone (GH) treatment-naive or had received Saizen® (freeze-dried formulation) for pediatric GHD (PGHD), or are currently receiving Saizen® freeze-dried formulation for adult GHD (AGHD)
- •Subjects who have binding antibody-negative (BAbs-) at screening
- •Subjects who have no evidence of concomitant disease, intercurrent illness, or resultant therapy that would interfere with subject compliance, the evaluation of study results, or compromise the safety of the subject
- •Female subjects of childbearing potential who have a negative serum pregnancy test at the screening visit (and at each scheduled visit during the study)
- •Subjects who are willing to comply with the procedures of the study
- •Subjects who are willing to sign an Independent Ethics Committee/Institutional Review Board approved informed consent form
- •Other protocol-defined inclusion criteria may apply
排除标准
- •Subjects who are currently receiving or have previously received treatment for adult GHD or any other indication, including PGHD, with a commercial GH product other than Saizen® freeze-dried formulation
- •Subjects who had a chronic underlying disease within 6 months prior to screening or concomitant medication(s) that in the opinion of the investigator would exclude the subject from the trial
- •Subjects who have significant renal impairment
- •Subjects who have diabetes mellitus
- •Subjects who are immunosuppressed
- •Subjects who have a current malignancy or a history of any malignancy (excluding fully-treated basal cell carcinoma)
- •Subjects who have participated in another study and received an investigational drug within 30 days prior to screening visit
- •Subjects who have clinically significant abnormal laboratory value(s)
- •Subjects who have known hypersensitivity or allergy to exogenous human GH or any of the excipients or phenol, the bacteriostatic agent in the Saizen® solution for injection
- •Other protocol-defined exclusion criteria may apply
研究组 & 干预措施
Saizen®
Experimental
干预措施: Saizen® (Drug)
结局指标
主要结局
Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen®
时间窗: Baseline up to Week 26
Binding antibodies (BAbs) are all antibodies which are capable of binding to the investigational drug molecule (Saizen®), irrespective of their binding site.
次要结局
- Number of Participants Who Developed Positive Neutralizing Antibodies (NAbs+) to Saizen®(Baseline up to Week 26)
- Insulin-like Growth Factor-I (IGF-1) Levels(Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26)
- Insulin-like Growth Factor-I Standard Deviation Score (IGF-1 SDS)(Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26)
- Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels(Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Day 1 up to 28 days after last dose of study treatment)
研究者
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