EUCTR2010-019374-32-HU进行中（未招募）不适用
A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)
ModigeneTech Ltd.0 个研究点目标入组 56 人开始时间: 2010年5月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Genders Eligible for Study: Both
- •Ages Eligible for Study: Males - 23 to 60 years, Females – 23 to 50
- •1. GHDA subjects as defined in the Consensus guidelines for the
- •diagnosis and treatment of adults with GH deficiency II
- •2. Patients using hormonal replacement therapy(s) for
- •deficiencies of other hypothalamo-pituitary axes must be on an
- •optimized and stable treatment regimen (hormone levels within
- •normal ranges on screening) for at least three months prior to
- •a. Temporary adjustment of glucocorticoid replacement
- •therapy, as appropriate, is acceptable.
- •b. Peripheral thyroid hormones (FT4, FT3) within the
- •normal range.
- •3. Fertile females must agree to use appropriate contraceptive
- •4. Female patients must have a negative serum pregnancy test at
- •5. GH replacement therapy for more than 6 months with
- •registered GH product.
- •6. The IGF-I level at screening within - 2 to + 2 SDS of the age
- •and sex normal ranges according to the central laboratory
- •measurements.1
- •7. Body Mass Index (BMI, kg/m2) of 19.0 to 35.0 kg/m2, both
- •8. Confirmed to be negative for anti r-hGH antibodies at the time
- •of screening.
- •9. Willing and able to provide written informed consent prior to
- •performing any study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Females who are pregnant or breast-feeding
- •2. Evidence of growth of pituitary adenoma or other intracranial
- •tumor within the last 12 months (confirmed by computer
- •tomography (CT) or magnetic resonance imaging (MRI) scan
- •(with contrast) within 3 months prior to study entry or at
- •screening).
- •3. History of malignancy other than i) cranial irradiation (for
- •cranial tumor or leukemia) causing GHD or ii) fully treated
- •basal cell carcinoma
- •4. Signs of intracranial hypertension at screening
- •5. Heart insufficiency, NYHA class greater than 2
- •6. History of impaired glucose tolerance, insulin resistance or
- •overt diabetes mellitus defined according to the American
- •Diabetes Association (ADA) Criteria
- •7. Impaired liver function defined as elevation of liver enzymes >2
- •x upper limit of normal
- •8. Impaired kidney function defined as increased serum creatinine
- •levels >1.5 x upper limit of normal
- •9. Active acromegaly in the last 18 months and less than 6 months
- •of active r-hGH replacement therapy
- •10. Active Carpal tunnel syndrome
- •11. Prader-Willi syndrome
- •12. Active Cushing's syndrome within the last 12 months
- •13. Systemic corticosteroids other than in replacement doses within
- •the 3 months before study entry (temporary adjustment of
- •glucocorticoids, as appropriate, is acceptable)
- •14. Anabolic steroids other than gonadal steroid replacement
- •therapy within 2 months before study entry
- •15. History of non-compliance with medications, uncooperativeness
- •or drug abuse
- •16. Blood donation or any major blood loss >500 mL within the
- •past 90 days prior to study entry
- •17. Patients who, based on the investigator’s judgment, have a
- •clinically significant or unstable medical or surgical condition
- •that may preclude safe and complete study participation.
- •Conditions may include cardiovascular, peripheral vascular,
- •pulmonary, hepatic, renal, or neurological disease, as
- •determined by medical history, physical examination,
- •laboratory tests or ECG
- •18. Patients who participated in any investigational medicinal
- •product (IMP) study within the last 2 months
- •19. History of positive serology to HBC, HBV and HIV
研究者
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