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 States, Australia, Germany36 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 range
23 Years – 70 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)