Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in AGHD

• Status: Terminated
• Trial end date: 2017-11-30
• Target enrollment: 0
• Participant gender: All

Summary

Open-label extension study to evaluate the safety of long-term twice-monthly administration of somavaratan in adults with Growth Hormone Deficiency (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

• Documented GHD during adulthood

• Subjects naive to somavaratan must have an IGF-1 SDS value ≤ 0 at Screening

• Subjects taking other hormone replacement therapy must have been on a stable course of treatment for at least 3 months

• 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

• BMI (kg/m2) 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 HIV wasting syndrome (HIV testing not required)

• History of malignancy in adulthood (subjects with a history of childhood malignancy that were subsequently treated with rhGH in childhood and remain GHD in adulthood may be enrolled)

• Women who are pregnant or breastfeeding

• Treatment with an investigational drug other than somavaratan within 30 days prior to Screening

• A significant abnormality in Screening laboratory results