A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)

• Conditions: Growth Hormone Deficiency; MedDRA version: 12.1Level: LLTClassification code 10056438Term: Growth hormone deficiency

• Registration Number: EUCTR2010-019374-32-SI
• Lead Sponsor: ModigeneTech Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-04
• Last Update Posted: 7 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Genders Eligible for Study: Both
Ages Eligible for Study: Males - 23 to 60 years, Females – 23 to 50
years.
1. GHDA subjects as defined in the Consensus guidelines for the
diagnosis and treatment of adults with GH deficiency II
(2007).
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
screening:
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
methods
4. Female patients must have a negative serum pregnancy test at
inclusion.
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
inclusive
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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified