Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency
- Conditions
- Adult or childhood onset growth hormone deficiency (GHD)MedDRA version: 17.0Level: PTClassification code 10056438Term: Growth hormone deficiencySystem Organ Class: 10014698 - Endocrine disordersTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2013-000830-37-NL
- Lead Sponsor
- OPKO Biologics Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 189
1. Men and women between the age of 23 to 70 years old at screening, inclusive
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 lab.
• Adrenal insufficiency – subjects that are sufficient with documented test in last 6 months or on stable replacement.
4. Subjects with Diabetes Insipidus should be on stable treatment for at least 6 months
5. No rhGH replacement therapy or use of GH secretagogues for at least 9 months with any registered or investigational rhGH 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 screening.
10. Women of childbearing potential must agree to use appropriate contraceptive methods. For the purposes of this protocol, a history of tubal ligation, bilateral oophorectomy or hysterectomy, or post-menopausal 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. Up to date cancer screening according to Dutch Cancer Screening Guidelines for the Early Detection of Cancer (‘bevolkingsonderzoek’) for breast, cervical, colon.
Up to date cancer screening for prostate cancer (through PSA measurement at screening) and skin cancer through physical examination at screening.
13. 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.
14. Subject had a DXA screening and the results are interpretable according to the study plan.
15. 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 170
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 20
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. 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 recurrence-free 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
6. History of overt diabetes mellitus (including currently treated, well-controlled DM) defined according to the American Diabetes Association (ADA) Criteria. 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 5(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 drug abuse
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 investigational medicinal product (IMP) within the last 2 months. Subjects with previous participation in investigational studies must have recovered from all adverse effects.
17. Subjects who participated within the last 12 months in any clinical trial involving the use of medicinal products (investigational or approved) that impact insulin levels, or that included specific dietary or physical activity requirements are excluded
18. History of positi
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method