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

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ClinicalTrials.gov Identifier: NCT02526420
Recruitment Status : Completed
First Posted : August 18, 2015
Last Update Posted : November 9, 2016
Sponsor:
Collaborator:
Premier Research Group plc
Information provided by (Responsible Party):
Versartis Inc.

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

Condition or disease Intervention/treatment Phase
Adult Growth Hormone Deficiency Drug: somavaratan Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Dose Finding, International Phase 2 Study With Once Monthly Subcutaneous VRS-317 in Adult Growth Hormone Deficiency (GHD)
Study Start Date : July 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016


Arm Intervention/treatment
Experimental: Cohort A: Somavaratan in Older Adults
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects >= 35 years of age
Drug: somavaratan
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly
Other Name: VRS-317

Experimental: Cohort B: Somavaratan in Younger Adults
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects < 35 years of age
Drug: somavaratan
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly
Other Name: VRS-317

Experimental: Cohort C: Somavaratan in Women on Estrogen
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in female subjects on oral estrogen (regardless of age)
Drug: somavaratan
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly
Other Name: VRS-317




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   23 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02526420


Locations
United States, California
AMCR Institute Inc.
Escondido, California, United States, 92025
Therapeutic Research Institute of Orange County
Laguna Hills, California, United States, 92653
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Stanford University
Stanford, California, United States, 94305
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Nevada
Palm Research Center
Las Vegas, Nevada, United States, 89128
United States, Texas
Endocrine Associates of Dallas
Plano, Texas, United States, 75093
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
Australia, Queensland
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
St Vincent's Hospital
Fitzroy, Victoria, Australia, 3065
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Germany
Charite-Universitätsmedizin
Berlin, Germany, 10117
Universitätsklinikum Essen
Essen, Germany, D- 45147
United Kingdom
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
Sponsors and Collaborators
Versartis Inc.
Premier Research Group plc
Investigators
Study Director: Daniela Rogoff, MD, PhD Versartis Inc.

Additional Information:
Responsible Party: Versartis Inc.
ClinicalTrials.gov Identifier: NCT02526420     History of Changes
Other Study ID Numbers: 15VR7
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: November 9, 2016
Last Verified: November 2016

Keywords provided by Versartis Inc.:
VRS-317
Long Acting Growth Hormone
Versartis
somavaratan
Growth Hormone Deficiency
Adult Growth Hormone Deficiency
AGHD
Growth Hormone Replacement
Growth Hormone Replacement Therapy
XTEN

Additional relevant MeSH terms:
Dwarfism, Pituitary
Dwarfism
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs