Versartis International Trial in Adults With Long-Acting Growth Hormone (VITAL)

Versartis

Status and phase: Completed; Phase 2

Conditions: Adult Growth Hormone Deficiency

Treatments: Drug: somavaratan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02526420

15VR7

Details and patient eligibility

About

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

Full description

A Phase 2, dose finding safety study to evaluate an individualized monthly VRS-317 dosing regimen in adults with GHD. This is an open-label, international, multicenter study with VRS-317 treatment for five months. This treatment period will include monthly dose titrations until a subject's mean IGF-I SDS value is within a target range for two consecutive months. Subjects will be stratified into three cohorts based on sensitivity to rhGH.

Enrollment: 36 patients

Sex: All

Ages: 23 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Cohort A: Somavaratan in Older Adults

Experimental group

Description:

Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects \>= 35 years of age

Treatment:

Drug: somavaratan

Cohort B: Somavaratan in Younger Adults

Experimental group

Description:

Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects \< 35 years of age

Treatment:

Drug: somavaratan

Cohort C: Somavaratan in Women on Estrogen

Experimental group

Description:

Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in female subjects on oral estrogen (regardless of age)

Treatment:

Drug: somavaratan