NCT00297713已完成2 期
A Phase II, Multi-Center, Multi-Dose, Randomized, Open-Label, Parallel Group Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug Safety
Altus Pharmaceuticals6 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2005年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 6
研究概览
简要总结
ALTU-238 is a long acting crystalline formulation of recombinant human growth hormone (rhGH) that is being developed for the treatment of growth hormone deficiency in adults and children. ALTU-238 is designed to require fewer injections than the currently available formulations of 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Growth hormone deficient men and women ages 18-60 years with a hypothalamic and/or pituitary structural lesion or longstanding idiopathic GHD
- •Growth hormone deficiency as determined by pituitary testing within the last five years by either of the two following tests:
- •Insulin hypoglycemia (glucose < 50 mg/dL) with maximum GH < 5 ng/mL (5 µg/L) by radioimmunoassay or < 2.5 µg/L, if measured by immunoradiometric assay
- •Arginine-GHRH infusions with maximum GH < 5 ng/mL (5 µg/L) or < 2.5 µg/L, if measured by immunoradiometric assay
- •Women must be of non-child bearing potential (hysterectomy, tubal ligation, or IUD are acceptable) during the three months prior to entering the study, or post-menopausal (no menses for one year or more), or six to twelve months without menses and β-estradiol levels < 20 pg/mL
- •Glucocorticoid use is allowed provided the subject has been on physiologic (<7.5 mg prednisone or equivalent/day) replacement doses for at least 3 months
- •Free thyroxine (T4) within the normal range at Screening. If the subject is receiving thyroid hormone replacement therapy, the dose must be stable for at least 6 weeks prior to Screening
- •Willing and able to provide written informed consent
- •BMI 20 - 36 kg/m2
排除标准
- •Any previous or ongoing clinically significant illness that, in the opinion of the investigator, could prevent the subject from completing the study
- •Any history of cancer within the past 5 years, except for dermal squamous and basal cell carcinoma with documented 6-month remission. Subjects with a more recent history of successfully treated cervical carcinoma in situ will not be excluded provided there is documented 12-month remission
- •BMI <20 or >36 kg/m2
- •Any allergic or abnormal reaction to human growth hormone
- •Inability of the subject to discontinue use of their regularly prescribed human growth hormone treatment from six weeks prior to Day -1 through the completion of the study
- •Serum creatinine > 1.4 mg/dL
- •Hypocalcemia or hypercalcemia from any cause
- •Hyperparathyroidism, osteomalacia or any other disorder which may affect bone and bone markers including the use of bisphosphonates or other medications for osteoporosis
- •Participation in another clinical trial 30 days prior to screening
- •Demonstrated inability to comply with protocol requirements (e.g. uncooperative attitude, inability to return for follow-up visits, history of medical non-compliance, and/or poor likelihood of completing the study)
- •Blood donation within 56 days of the screening visit
- •Plasma donation within seven days of the screening visit
- •Positive serum pregnancy test
- •Women of child bearing potential
- •Abuse of alcohol; to be determined by principal investigator
- •Abuse of prescription or illicit drugs; to be determined by principal investigator
研究者
研究点 (6)
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