Versartis International Trial in Adults With Long-Acting Growth Hormone

Completed · Phase 2

Conditions studied: Adult Growth Hormone Deficiency

In brief

A Phase 2, open-label dose-finding safety study of individualized monthly VRS-317 dosing for five months in adults with GHD.

Key facts

Study ID

NCT02526420

Run by

Versartis Inc.

People needed

36

Starts

2015-07-01

Expected to finish

2016-10-01

Last updated by the study team

2022-07-26

Who can join

Age: 23 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• Subjects with a prior history of malignancy excluding adequately treated non-melanoma skin cancers or in situ carcinoma of the cervix.
• Women who are pregnant or breastfeeding.
• Subjects with a significant abnormality in Screening laboratory results

Where it is running

• AMCR Institute Inc. — Escondido, California, United States
• Therapeutic Research Institute of Orange County — Laguna Hills, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Stanford University — Stanford, California, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Palm Research Center — Las Vegas, Nevada, United States
• Endocrine Associates of Dallas — Plano, Texas, United States
• Swedish Medical Center — Seattle, Washington, United States
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• St Vincent's Hospital — Fitzroy, Victoria, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• Charite-Universitätsmedizin — Berlin, Germany
• Universitätsklinikum Essen — Essen, Germany
• Queen Elizabeth Hospital — Birmingham, B152gw, United Kingdom
• William Harvey Research Institute — London, EC1M 6BQ, United Kingdom
• Hull Royal Infirmary — Hull, East Yorkshire, HU3 2RW, United Kingdom
• The Christie NHS Foundation Trust — Manchester, M20 4BX, United Kingdom

Full record on ClinicalTrials.gov

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