EUCTR2013-000830-37-SK进行中（未招募）1 期
A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 189
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
- •1. Men and women between the age of 23 to 70 years old at screening,
- •2. GHD subjects as defined in the Consensus guidelines for the diagnosis
- •and treatment of adults with GH deficiency II (2007). The following
- •cutoff values for the diagnosis of GHD will be used
- •Insulin tolerance test or glucagon test, the validated cutoff for GHD in
- •adults is a peak GH response = 3 µg/L
- •Growth-hormone-releasing hormone (GHRH) + arginine : for those
- •with a body mass index:
- •- BMI <25 kg/m2, a peak GH =11 µg/L;
- •- BMI 25–30 kg/m2 (included), a peak GH=8 µg/L;
- •- BMI >30 kg/m2, a peak GH=4 µg/L.
- •3. Subjects 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 screening:
- •Temporary adjustment of glucocorticoid replacement therapy, as
- •appropriate, is acceptable.
- •Peripheral thyroid hormones (FT4) within the normal range of the
- •central or local lab .
- •Adrenal insufficiency – documented adrenal status (subjects that are
- •sufficient with documented test in last 6 months or insufficient and on
- •stable replacement.
- •4. Subjects with Diabetes Insipidus should be on stable treatment for at
- •least 6 months
- •5. No r-hGH replacement therapy or use of GH secretagogues for at least
- •9 months with any registered or investigational r-hGH or GH
- •secretagogue product.
- •6. The IGF-I level at screening =-1 SDS of the age and sex normal
- •ranges according to the central laboratory measurements.
- •7. For patients treated for Cushing's, at least two years elapsed since
- •pituitary surgery and in biochemical remission without current medical
- •therapy for the condition, documented within 6 months of study entry
- •8. Body Mass Index (BMI, kg/m2) of 23.0 to 35.0 kg/m2, both inclusive
- •9. Confirmed to be negative for anti r-hGH antibodies at the time of
- •10. Women of childbearing potential and fertile men must agree to use
- •appropriate contraceptive methods during the study until one month
- •after the last study visit. For the purposes of this protocol, a history of
- •tubal ligation, bilateral oophorectomy or hysterectomy, or postmenopausal
- •women constitutes non-fertility. Fertile men must agree to
- •use a barrier contraceptive (condom). Vasectomy older than 6 months is
- •also acceptable.
- •11. Women of childbearing potential must have a negative serum
- •pregnancy test at inclusion.
- •12. Subjects who are on a stable diet and exercise regime and do not
- •have plans to modify their diet or exercise for at least 12 months.
- •13. Subject had a DXA screening and the results are interpretable
- •according to the study plan.
- •14. Willing and able to provide written informed consent prior to
- •performing any study procedures.
- •Inclusion into Treatment Period III (LT-OLE):
- 另有 11 项未显示
排除标准
- •1. Women who are pregnant or breast-feeding (at least 6 months delay
- •from childbirth or lactation)
- •2. Evidence of growth benign intracranial tumor within the last 12
- •months (determined by comparing a previous MRI to a new one
- •obtained no more than 6 months prior to study entry to clarify dynamics of growth).
- •3. Suspected or diagnosed ongoing cancer or history of any cancer.
- •Exceptions to this exclusion criterion include resected in situ carcinoma
- •of the cervix and squamous cell or basal cell carcinoma of the skin with
- •complete local excision. Patients with GHD attributed to treatment of
- •intracranial malignant lesions in childhood or adulthood (or, tumors) or
- •leukemia may also be enrolled into the study provided that a recurrencefree
- •survival period of at least 5 years is well documented in the study record.
- •4. Signs of intracranial hypertension at screening
- •5. Heart insufficiency, NYHA class > 2 (Appendix C)
- •6. History of overt diabetes mellitus (including currently treated, wellcontrolled
- •DM) defined according to the American Diabetes Association
- •(ADA) Criteria , including ongoing administration of anti-diabetic
- •medications/agents. A history of gestational diabetes, resolved after childbirth, is not exclusionary.
- •7. Impaired liver function defined as:
- •a. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
- •greater than three times the upper limit of normal (ULN) at Screening
- •visit in a patient without prior history of elevated LFTs (non-alcoholic
- •fatty liver disease is not excluded, but requires etiological clarification
- •prior to eligibility confirmation) OR
- •b. Total bilirubin greater than 2 times the ULN at Screening
- •8. Subjects with severe renal failure at the Screening visit (defined by
- •GFR < 30 mL/min using MDRD Study Equation)
- •9. History of Acromegaly
- •10. For patients treated for Cushing's, biochemical, documented
- •evidence of possible recurrence within 2 months of study entry
- •according to 2008 Endocrine Society Guideline
- •11. Active Carpal tunnel syndrome suspected on a recent history (last 6
- •months) or ongoing symptoms such as: Numbness, or tingling in hand
- •and/or finger, pain in the arm, palm or forearm, both occurring also at
- •night and with intensive use of the hand; trouble gripping objects and
- •weakness in the thumb.
- •12. Systemic corticosteroids other than in replacement doses within the
- •3 months before study entry (temporary adjustment of glucocorticoids,
- •as appropriate, is acceptable)
- •13. Anabolic therapy or supplements (subject to Medical Monitor's
- •decision) other than gonadal steroid replacement therapy within 2
- •months before study entry
- •14. History of non-compliance with medications, un-cooperativeness or
- •15. Subjects 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.
- •16. Subjects who participated in any study and had administration of an
- 另有 5 项未显示
研究者
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