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

Primary Purpose

Adult Growth Hormone Deficiency

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
somavaratan
Sponsored by
Versartis Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Growth Hormone Deficiency focused on measuring VRS-317, Long Acting Growth Hormone, Versartis, somavaratan, Growth Hormone Deficiency, Adult Growth Hormone Deficiency, AGHD, Growth Hormone Replacement, Growth Hormone Replacement Therapy, XTEN

Eligibility Criteria

23 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • AMCR Institute Inc.
  • Therapeutic Research Institute of Orange County
  • Cedars-Sinai Medical Center
  • Stanford University
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Palm Research Center
  • Endocrine Associates of Dallas
  • Swedish Medical Center
  • Princess Alexandra Hospital
  • St Vincent's Hospital
  • The Alfred Hospital
  • Charite-Universitätsmedizin
  • Universitätsklinikum Essen
  • Queen Elizabeth Hospital
  • William Harvey Research Institute
  • Hull Royal Infirmary
  • The Christie NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort A: Somavaratan in Older Adults

Cohort B: Somavaratan in Younger Adults

Cohort C: Somavaratan in Women on Estrogen

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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)
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

Secondary Outcome Measures

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

Full Information

First Posted
August 13, 2015
Last Updated
July 22, 2022
Sponsor
Versartis Inc.
Collaborators
Premier Research Group plc
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1. Study Identification

Unique Protocol Identification Number
NCT02526420
Brief Title
Versartis International Trial in Adults With Long-Acting Growth Hormone
Acronym
VITAL
Official Title
An Open-Label, Dose Finding, International Phase 2 Study With Once Monthly Subcutaneous VRS-317 in Adult Growth Hormone Deficiency (GHD)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Versartis Inc.
Collaborators
Premier Research Group plc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Growth Hormone Deficiency
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort A: Somavaratan in Older Adults
Arm Type
Experimental
Arm Description
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects >= 35 years of age
Arm Title
Cohort B: Somavaratan in Younger Adults
Arm Type
Experimental
Arm Description
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in subjects < 35 years of age
Arm Title
Cohort C: Somavaratan in Women on Estrogen
Arm Type
Experimental
Arm Description
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly in female subjects on oral estrogen (regardless of age)
Intervention Type
Drug
Intervention Name(s)
somavaratan
Other Intervention Name(s)
VRS-317
Intervention Description
Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly
Primary Outcome Measure Information:
Title
Safety as measured by the number of subjects with adverse events, concomitant medications, safety labs, vital signs and physical exams
Description
Safety observations include adverse events, concomitant medications, safety labs, vital signs and physical exams.
Time Frame
5 months
Title
Starting doses (proportion of subjects who achieve normalization of IGF-I SDS response during the first dosing interval )
Description
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)
Time Frame
5 months
Title
Dose titration plan (proportion of subjects who achieve a mean IGF-I SDS within the defined target range after each dose titration)
Description
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
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Immunogenicity of VRS-317 by measurement of serum anti-drug antibody (ADA) titers
Description
To evaluate the immunogenicity of VRS-317 by measurement of serum anti-drug antibody (ADA) titers
Time Frame
5 months
Title
Immunogenicity of VRS-317 by detection of neutralizing antibodies (NAbs)
Description
To evaluate the immunogenicity of VRS-317 by detection of neutralizing antibodies (NAb)
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Rogoff, MD, PhD
Organizational Affiliation
Versartis Inc.
Official's Role
Study Director
Facility Information:
Facility Name
AMCR Institute Inc.
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Therapeutic Research Institute of Orange County
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Palm Research Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Endocrine Associates of Dallas
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
St Vincent's Hospital
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Charite-Universitätsmedizin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
D- 45147
Country
Germany
Facility Name
Queen Elizabeth Hospital
City
Birmingham
State/Province
B152gw
Country
United Kingdom
Facility Name
William Harvey Research Institute
City
London
State/Province
Ec1m 6bq
Country
United Kingdom
Facility Name
Hull Royal Infirmary
City
Hull, East Yorkshire
State/Province
Hu3 2rw
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
State/Province
M20 4bx
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.versartis.com
Description
Company Website

Learn more about this trial

Versartis International Trial in Adults With Long-Acting Growth Hormone

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