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Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in AGHD

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ClinicalTrials.gov Identifier: NCT02719990
Recruitment Status : Active, not recruiting
First Posted : March 25, 2016
Last Update Posted : November 24, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Open-label extension study to evaluate the safety of long-term twice-monthly administration of somavaratan in adults with Growth Hormone Deficiency (GHD).

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

Detailed Description:
An open-label extension study to evaluate the safety of long-term twice-monthly administration of somavaratan in adults with Growth Hormone Deficiency (GHD). This multicenter study is open to subjects completing a Versartis adult GHD study as well as approximately 40 new somavaratan naïve subjects (either rhGH treatment naïve or currently receiving daily rhGH therapy). All subjects will receive twice-monthly (every 15 days ± 2 days) subcutaneous (SC) somavaratan. Doses will be titrated to each subject's individual IGF-I responses based on the IGF-I level 7 days post-dose until a maintenance dose is achieved. Subjects receiving somavaratan in a previous somavaratan study will have their dose decreased by half (minimum dose of 20 mg, 40 mg for women on estrogen, rounded down to the nearest even number) and will be titrated per the Dose Titration Plan. New subjects enrolling in this study will be assigned to one of two cohorts based on sensitivity to rhGH and titrated per the Dose Titration Plan.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Long-Term Extension Study of the Safety of Somavaratan (VRS-317) in Adults With Growth Hormone Deficiency (GHD)
Actual Study Start Date : February 9, 2016
Primary Completion Date : October 31, 2017
Estimated Study Completion Date : December 2017


Arms and Interventions

Arm Intervention/treatment
Experimental: Somavaratan in adults with GHD
Cohort 1: Long-acting recombinant human growth hormone therapy administered subcutaneously twice-monthly in adult subjects with GHD irrespective of age and gender
Drug: somavaratan
Long-acting recombinant human growth hormone therapy administered subcutaneously twice-monthly
Other Name: VRS-317
Experimental: Somavaratan in women on estrogen
Cohort 2: Long-acting recombinant human growth hormone therapy administered subcutaneously twice-monthly in adult female subjects with GHD on oral estrogen (regardless of age)
Drug: somavaratan
Long-acting recombinant human growth hormone therapy administered subcutaneously twice-monthly
Other Name: VRS-317


Outcome Measures

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: up to first 5 months ]
    Safety observations include adverse events, concomitant medications, safety labs, vital signs and physical exams

  2. Safety as measured by the number of subjects with adverse events, concomitant medications, safety labs, vital signs and physical exams [ Time Frame: up to 4 years ]
    Safety observations include adverse events, concomitant medications, safety labs, vital signs and physical exams


Secondary Outcome Measures :
  1. Immunogenicity of VRS-317 by measurement and characterization of serum anti-drug antibody (ADA) titers [ Time Frame: Quarterly for up to 4 years ]
    To evaluate the immunogenicity of VRS-317 by measurement and characterization of serum anti-drug antibody (ADA) titers

  2. Pharmacodynamics of VRS-317 by measurement of serum Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) [ Time Frame: Quarterly for up to 4 years ]
    To evaluate the pharmacodynamics of VRS-317 by measurement of serum Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor Binding Protein-3 (IGFBP-3)

  3. Evaluation of the starting dose and dose titration plan [ Time Frame: Monthly for 5 months ]
    To evaluate the starting dose and the dose titration plan of twice-monthly somavaratan during the titration phase of treatment

  4. Evaluation of the maintenance dose and dose titration plan [ Time Frame: Quarterly for up to 4 years ]
    To evaluate the maintenance dose and the dose titration plan of twice-monthly somavaratan during long-term treatment


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  • Documented GHD during adulthood
  • Subjects naive to somavaratan must have an IGF-1 SDS value ≤ 0 at Screening
  • Subjects taking other hormone replacement therapy must have been on a stable course of treatment for at least 3 months
  • 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
  • BMI (kg/m2) between 18.0 and 40.0

Exclusion Criteria:

  • Untreated adrenal insufficiency
  • Recently diagnosed thyroid dysfunction which is not being treated or has not been stable on therapy for at least 3 months
  • Currently taking anti-inflammatory dose of glucocorticoids that could potentially compromise safety or efficacy assessments
  • Currently taking a GHRH or IGF-I product
  • Current significant cardiovascular disease, heart insufficiency of New York Heart Association (NYHA) class > 2
  • Current significant disease thought to increase risk of receiving growth hormone or confound assessment of study outcomes
  • History of diabetes mellitus or inadequate glucose control
  • Current drug or alcohol abuse
  • Current HIV wasting syndrome (HIV testing not required)
  • History of malignancy in adulthood (subjects with a history of childhood malignancy that were subsequently treated with rhGH in childhood and remain GHD in adulthood may be enrolled)
  • Women who are pregnant or breastfeeding
  • Treatment with an investigational drug other than somavaratan within 30 days prior to Screening
  • A significant abnormality in Screening laboratory results
Contacts and Locations

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): NCT02719990


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
United States, Nevada
Palm Research Center
Las Vegas, Nevada, United States, 89128
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
Sponsors and Collaborators
Versartis Inc.
Premier Research Group plc
Investigators
Study Director: Daniela Rogoff, MD, PhD Versartis Inc.
More Information

Responsible Party: Versartis Inc.
ClinicalTrials.gov Identifier: NCT02719990     History of Changes
Other Study ID Numbers: 15VR8
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

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:
Endocrine System Diseases
Dwarfism, Pituitary
Dwarfism
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