NCT02410356终止3 期
A Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (Genotropin(R)) in 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
- 终止
- 入组人数
- 34
- 试验地点
- 50
- 主要终点
- Percentage of participants with adverse events
研究概览
简要总结
This study assesses the safety and tolerability of weekly TV-1106 compared to daily rhGH in adults with GHD who have previously been treated with rhGH.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males and females 18 years of age or over
- •diagnosis of adult GHD for at least 6 months, or patients who have hypopituitarism from surgical resection
- •treated with a stable dose of daily rhGH for at least 3 months prior to screening
- •stable, adequate doses of replacement hormones (adrenal, thyroid, estrogen, testosterone, vasopressin) for at least 3 months prior to screening
- •Other criteria apply, please contact the investigator for more information
排除标准
- •patients with acute or chronic conditions or diseases that could confound results of the study or put the patient at undue risk as determined by the investigator
- •Presence of contraindications to rhGH treatment
- •patients who have participated in another clinical trial with a new chemical/biological entity within 3 months of screening
- •patients with known active malignancy (excluding surgically removed basal cell carcinoma or carcinoma in situ of cervix) d. patients with a previously treated pituitary tumor with evidence of tumor progression in the past year
- •patients with a new diagnosis of pituitary adenoma or other intracranial tumor within 12 months of screening
- •presence of Prader-Willi syndrome, Turner's syndrome, untreated adrenal insufficiency, active acromegaly in the past 5 years, or active Cushing's syndrome in the past year.
- •patients with type 1 diabetes mellitus oror poorly controlled type 2 diabetes mellitus as indicated by a glycated hemoglobin (HbA1c) ≥8%
- •patients using weight reducing agents or appetite suppressants
- •Other criteria apply, please contact the investigator for more information
研究组 & 干预措施
TV-1106
Experimental
TV-1106 to be injected once weekly.
干预措施: TV-1106 (Drug)
dGH
Active Comparator
dGH to be given as daily injections.
干预措施: dGH (Drug)
结局指标
主要结局
Percentage of participants with adverse events
时间窗: 48 weeks
Safety of TV-1106 compared to reference drug
次要结局
- Change from baseline in Insulin-like Growth Factor 1 Standard Deviation Score(Baseline, Weeks: 4, 8, 12, 16, 24, 36, 48)
研究者
研究点 (50)
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