A Clinical Study in AGHD to Assess Safety, Tolerability and Efficacy of GX-H9 (NCT02946606) | Clinical Trial Compass
CompletedPhase 2
A Clinical Study in AGHD to Assess Safety, Tolerability and Efficacy of GX-H9
South Korea45 participantsStarted 2015-01
Plain-language summary
This is a randomized, active-controlled, open-label, sequential dose group, Phase 1b/2 study designed to assess the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of weekly and every other week doses of GX-H9 in the treatment of AGHD.
Who can participate
Age range20 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Is a male or female aged ≥20 and 65 years with AGHD, either adult onset GHD due to hypothalamic pituitary disease or childhood onset GHD that is either idiopathic or due to hypothalamic pituitary disease or due to genetic causes.
✓. Has documented confirmation (medical history) of GH deficiency during adulthood by 1 or more growth hormone (GH) stimulation tests, as follows:
✓. Has been treated with stable hormonal replacement therapies for deficiencies of other hypothalamo pituitary axes and must have been on an optimized and stable treatment regimen for at least 3 months before screening (free thyroxine \[T4\] level within normal range at screening). Temporary adjustment of glucocorticoid replacement therapy, as appropriate, is acceptable.
✓. Has a screening IGF-1 level of at least 1 standard deviation (SD) score (IGF-1 SD score \<1) below the mean IGF-1 level standardized for age and gender according to the central laboratory reference values.
✓. Has a BMI of ≥18.0 and 35.0 kg/m2 (both male and female subjects).
✓. Has a confirmed negative test result for anti-recombinant human growth hormone (anti-rhGH) antibodies at screening.
✓. Must agree to use appropriate contraceptive methods (ie, condoms, cervical cap in conjunction with spermicide, sterilization, and intra uterine device) during the study and for 6 months after the last dose of study drug.
✓. Female subjects must have a negative serum pregnancy test result at screening.
Exclusion criteria
✕. Has evidence of growth of pituitary adenoma or other intracranial tumor within the last 12 months which has to be confirmed by computed tomography or magnetic resonance imaging scan (with contrast) within 3 months before screening. (Subjects with inactive remnant intracranial tumors are eligible).
What they're measuring
1
The change in insulin-like growth factor-1 (IGF-1) levels in relation to time and dose strength
✕. Is currently receiving antitumor therapy and has a history of malignancy other than i) cranial tumor or leukemia causing GHD, or ii) fully treated basal cell carcinoma or evidence of active malignancy.
✕. Has any clinically significant electrocardiogram (ECG) abnormality at screening.
✕. Has evidence of intracranial hypertension at screening.
✕. Has uncontrolled diabetes mellitus with diet and exercise, as determined based on glycated hemoglobin (HbA1c) levels ≥7.0% at screening.
✕. Has impaired liver function defined as elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.0 × upper limit of normal (ULN).
✕. Has impaired kidney function defined as increased serum creatinine levels greater than 1.5 × ULN.
✕. Has had active acromegaly within 18 months before screening.