Versartis International Trial in Adults With Long-Acting Growth Hormone (NCT02526420) | Clinical Trial Compass
CompletedPhase 2
Versartis International Trial in Adults With Long-Acting Growth Hormone
United States36 participantsStarted 2015-07
Plain-language summary
A Phase 2, open-label dose-finding safety study of individualized monthly VRS-317 dosing for five months in adults with GHD.
Who can participate
Age range23 Years – 70 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:
* Female subjects of childbearing potential must have negative pregnancy test and use appropriate contraceptive methods
* Subjects must have documented GHD during adulthood.
* Subjects taking other hormone replacement therapy must have been on a stable course of treatment for at least 3 months.
* Subjects with underlying disorders responsible for the subject's GHD must have been clinically stable for at least 6 months.
* Subjects receiving daily rhGH injections must washout for 14 days.
* Subjects must provide signed informed consent.
* Subjects must have a BMI (kg/m2) between 19.0 and 35.0.
Exclusion Criteria:
* Subjects with diabetes mellitus or inadequate glucose control
* Subjects with untreated adrenal insufficiency.
* Subjects with free thyroxine outside the normal reference range.
* Subjects currently taking oral glucocorticoids, except for physiological maintenance doses of oral glucocorticoids in subjects with multiple pituitary hormone deficiencies.
* Subjects with current significant cardiovascular disease, heart insufficiency of NYHA class \> 2.
* Subjects with current significant cerebrovascular, pulmonary, neurological, renal, inflammatory, or hepatobiliary disease.
* Subjects with current papilledema.
* Subjects with a history of persistent or recurring migraines.
* Subjects with current edema (≥ CTCAE Grade 2).
* Subjects with current drug or alcohol abuse.
* Subjects with a documented history of HIV, current HBV or HCV infection
* Subje…
What they're measuring
1
Safety as measured by the number of subjects with adverse events, concomitant medications, safety labs, vital signs and physical exams
Timeframe: 5 months
2
Starting doses (proportion of subjects who achieve normalization of IGF-I SDS response during the first dosing interval )
Timeframe: 5 months
3
Dose titration plan (proportion of subjects who achieve a mean IGF-I SDS within the defined target range after each dose titration)