Versartis International Trial in Adults With Long-Acting Growth Hormone

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Versartis Inc.
• Collaborator: Premier Research Group plc
• Treatments: Hormones

Criteria

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

• 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