Adult Growth Hormone DeficiencyPhase 2VITALNCT02526420
Versartis International Trial in Adults With Long-Acting Growth Hormone
A Phase 2 study testing somavaratan in people with Adult Growth Hormone Deficiency, run by Versartis Inc. at 18 sites in 4 countries.
Trial summary
A Phase 2, open-label dose-finding safety study of individualized monthly VRS-317 dosing for five months in adults with GHD. Read more about this study
- Who is it for?
- Ages 23 to 70 years
- Conditions the study is for
- Adult Growth Hormone Deficiency
- What is being tested?
- somavaratan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 18 sitesin 4 countries
- Study dates
- Jul 2015to Oct 2016
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
United States9 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
AMCR Institute Inc.
Escondido, California, 92025
Therapeutic Research Institute of Orange County
Laguna Hills, California, 92653
Palm Research Center
Las Vegas, Nevada, 89128
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Endocrine Associates of Dallas
Plano, Texas, 75093
Swedish Medical Center
Seattle, Washington, 98122
Stanford University
Stanford, California, 94305
United Kingdom4 sites
Queen Elizabeth Hospital
Birmingham, B152gw
Hull Royal Infirmary
Hull, East Yorkshire, HU3 2RW
William Harvey Research Institute
London, EC1M 6BQ
The Christie NHS Foundation Trust
Manchester, M20 4BX
Australia3 sites
St Vincent's Hospital
Fitzroy, Victoria, 3065
The Alfred Hospital
Melbourne, Victoria, 3004
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Germany2 sites
Charite-Universitätsmedizin
Berlin, 10117
Universitätsklinikum Essen
Essen, D- 45147
About this study
Official title: An Open-Label, Dose Finding, International Phase 2 Study With Once Monthly Subcutaneous VRS-317 in Adult Growth Hormone Deficiency (GHD)
A Phase 2, open-label dose-finding safety study of individualized monthly VRS-317 dosing for five months in adults with GHD.
Read the 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.
- Conditions
- Adult Growth Hormone Deficiency
- Being tested
- somavaratan
- Keywords
- VRS-317, Long Acting Growth Hormone, Versartis, somavaratan, Growth Hormone Deficiency, Adult Growth Hormone Deficiency, AGHD, Growth Hormone Replacement, Growth Hormone Replacement Therapy, XTEN
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somavaratanDrug
Also called VRS-317
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Somavaratan in Older Adults | Experimental | Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects >= 35 years of age Receives: Drug: somavaratan |
| Cohort B: Somavaratan in Younger Adults | Experimental | Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects < 35 years of age Receives: Drug: somavaratan |
| Cohort C: Somavaratan in Women on Estrogen | Experimental | Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in female subjects on oral estrogen (regardless of age) Receives: Drug: somavaratan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as measured by the number of subjects with adverse events, concomitant medications, safety labs, vital signs and physical exams
Safety observations include adverse events, concomitant medications, safety labs, vital signs and physical exams.
Measured: 5 months
Starting doses (proportion of subjects who achieve normalization of IGF-I SDS response during the first dosing interval )
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)
Measured: 5 months
Dose titration plan (proportion of subjects who achieve a mean IGF-I SDS within the defined target range after each dose titration)
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
Measured: 5 months
Secondary outcomes (2)
Immunogenicity of VRS-317 by measurement of serum anti-drug antibody (ADA) titers
To evaluate the immunogenicity of VRS-317 by measurement of serum anti-drug antibody (ADA) titers
Measured: 5 months
Immunogenicity of VRS-317 by detection of neutralizing antibodies (NAbs)
To evaluate the immunogenicity of VRS-317 by detection of neutralizing antibodies (NAb)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versartis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
- Investigators
- Daniela Rogoff, MD, PhD, Study director, Versartis Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526420
- Sponsor's protocol ID
- 15VR7
- Acronym
- VITAL
- Status last verified
- Jul 2022
- First submitted
- 13 Aug 2015
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No