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

July 22, 2022 updated by: Versartis Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St Vincent's Hospital
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
  • Germany
      • Berlin, Germany, 10117
        • Charité-Universitätsmedizin
      • Essen, Germany, D- 45147
        • Universitätsklinikum Essen
  • United Kingdom
    • B152gw
      • Birmingham, B152gw, United Kingdom
        • Queen Elizabeth Hospital
    • Ec1m 6bq
      • London, Ec1m 6bq, United Kingdom
        • William Harvey Research Institute
    • Hu3 2rw
      • Hull, East Yorkshire, Hu3 2rw, United Kingdom
        • Hull Royal Infirmary
    • M20 4bx
      • Manchester, M20 4bx, United Kingdom
        • The Christie NHS Foundation Trust
  • United States
    • California
      • Escondido, California, United States, 92025
        • AMCR Institute Inc.
      • Laguna Hills, California, United States, 92653
        • Therapeutic Research Institute of Orange County
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Stanford, California, United States, 94305
        • Stanford University
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Palm Research Center
    • Texas
      • Plano, Texas, United States, 75093
        • Endocrine Associates Of Dallas
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

23 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • VRS-317

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
5 months
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)
5 months
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
5 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
5 months
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)
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Versartis Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Premier Research Group plc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Daniela Rogoff, MD, PhD, Versartis Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15VR7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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