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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 : Terminated (Phase 3 clinical trial of somavaratan in PGHD did not meet its primary endpoint of non-inferiority)
First Posted : March 25, 2016
Last Update Posted : March 8, 2018
Sponsor:
Collaborator:
Premier Research Group plc
Information provided by (Responsible Party):
Versartis Inc.

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 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
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017


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



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



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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

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: March 8, 2018
Last Verified: March 2018

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