Skip to main content
OpenTrials
Completed

NCT Number: NCT02526420

Versartis International Trial in Adults With Long-Acting Growth Hormone

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adult Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

23 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Princess Alexandra Hospital, Woolloongabba, Queensland, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somavaratan

Drug

Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly

Other names: VRS-317

Primary outcomes

  1. Safety as measured by the number of subjects with adverse events, concomitant medications, safety labs, vital signs and physical exams

    Time frame: 5 months

    Safety observations include adverse events, concomitant medications, safety labs, vital signs and physical exams.

  2. Starting doses (proportion of subjects who achieve normalization of IGF-I SDS response during the first dosing interval )

    Time frame: 5 months

    To evaluate the starting doses of VRS-317 for each cohort as measured by the proportion of subjects who achieve normalization of IGF-I SDS response during the first dosing interval (one month after the first dose)

  3. Dose titration plan (proportion of subjects who achieve a mean IGF-I SDS within the defined target range after each dose titration)

    Time frame: 5 months

    To evaluate the dose titration plan of VRS-317 for each cohort as measured by the proportion of subjects who achieve a mean IGF-I SDS within the defined target range after each dose titration

Secondary outcomes

  1. Immunogenicity of VRS-317 by measurement of serum anti-drug antibody (ADA) titers

    Time frame: 5 months

    To evaluate the immunogenicity of VRS-317 by measurement of serum anti-drug antibody (ADA) titers

  2. Immunogenicity of VRS-317 by detection of neutralizing antibodies (NAbs)

    Time frame: 5 months

    To evaluate the immunogenicity of VRS-317 by detection of neutralizing antibodies (NAb)

Sponsors and collaborators

Lead sponsor

Versartis Inc.

Industry

Collaborators

  • Premier Research

Registry information

Official study title

An Open-Label, Dose Finding, International Phase 2 Study With Once Monthly Subcutaneous VRS-317 in Adult Growth Hormone Deficiency (GHD)

Acronym: VITAL

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 18, 2015
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.