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Trial record 1 of 1 for:    NCT02526420
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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.

Tracking Information
First Submitted Date  ICMJE August 13, 2015
First Posted Date  ICMJE August 18, 2015
Last Update Posted Date November 9, 2016
Study Start Date  ICMJE July 2015
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2015)
  • 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.
  • 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)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2015)
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Versartis International Trial in Adults With Long-Acting Growth Hormone
Official Title  ICMJE An Open-Label, Dose Finding, International Phase 2 Study With Once Monthly Subcutaneous VRS-317 in Adult Growth Hormone Deficiency (GHD)
Brief Summary A Phase 2, open-label dose-finding safety study of individualized monthly VRS-317 dosing for five months in adults with GHD.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Adult Growth Hormone Deficiency
Intervention  ICMJE Drug: somavaratan
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly
Other Name: VRS-317
Study Arms  ICMJE
  • Experimental: Cohort A: Somavaratan in Older Adults
    Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects >= 35 years of age
    Intervention: Drug: somavaratan
  • Experimental: Cohort B: Somavaratan in Younger Adults
    Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects < 35 years of age
    Intervention: Drug: somavaratan
  • 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)
    Intervention: Drug: somavaratan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2016)
36
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2015)
40
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 23 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Germany,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02526420
Other Study ID Numbers  ICMJE 15VR7
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Versartis Inc.
Study Sponsor  ICMJE Versartis Inc.
Collaborators  ICMJE Premier Research Group plc
Investigators  ICMJE
Study Director: Daniela Rogoff, MD, PhD Versartis Inc.
PRS Account Versartis Inc.
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP