Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of So… (NCT02719990) | Clinical Trial Compass
TerminatedPhase 2
Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in Adult Growth Hormone Deficiency (AGHD)
Stopped: Phase 3 clinical trial of somavaratan in pediatric growth hormone deficiency (PGHD) did not meet its primary endpoint of non-inferiority.
36 participantsStarted 2016-02-11
Plain-language summary
Open-label extension study to evaluate the safety of long-term twice-monthly administration of somavaratan in adults with Growth Hormone Deficiency (GHD).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Female participants of childbearing potential must have negative pregnancy test and use appropriate contraceptive methods
* Documented GHD during adulthood
* Participants naive to somavaratan must have an IGF-1 SDS value ≤ 0 at Screening
* Participants taking other hormone replacement therapy must have been on a stable course of treatment for at least 3 months
* Underlying disorders responsible for the participant's GHD must have been clinically stable for at least 6 months
* Participants receiving daily rhGH injections must washout for ≥ 14 days
* Body mass index (BMI) (kilograms \[kg\]/meter square \[m\^2\]) between 18.0 and 40.0
Exclusion Criteria:
* Untreated adrenal insufficiency
* Recently diagnosed thyroid dysfunction which is not being treated or has not been stable on therapy for at least 3 months
* Currently taking anti-inflammatory dose of glucocorticoids that could potentially compromise safety or efficacy assessments
* Currently taking a GHRH or IGF-I product
* Current significant cardiovascular disease, heart insufficiency of New York Heart Association (NYHA) class \> 2
* Current significant disease thought to increase risk of receiving growth hormone or confound assessment of study outcomes
* History of diabetes mellitus or inadequate glucose control
* Current drug or alcohol abuse
* Current human immunodeficiency virus (HIV) wasting syndrome (HIV testing not required)
* History of malignancy in adulthood (participants with a history of…
What they're measuring
1
Number of Participants With Adverse Events (AEs)
Timeframe: From first dose of study drug up to approximately 2 years