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

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2016 by Versartis Inc.
Sponsor:
Collaborator:
Premier Research Group plc
Information provided by (Responsible Party):
Versartis Inc.
ClinicalTrials.gov Identifier:
NCT02719990
First received: March 16, 2016
Last updated: August 3, 2016
Last verified: August 2016
  Purpose
Open-label extension study to evaluate the safety of long-term twice-monthly administration of somavaratan in adults with Growth Hormone Deficiency (GHD).

Condition Intervention Phase
Adult Growth Hormone Deficiency (AGHD) Drug: somavaratan Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Versartis Inc.:

Primary Outcome Measures:
  • 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

  • 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:
  • 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

  • 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)

  • 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

  • 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


Estimated Enrollment: 250
Study Start Date: January 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02719990

Contacts
Contact: Eric Humphriss, MBA 1-650-963-8587 ehumphriss@versartis.com
Contact: Shelby Young, RN, BS 1-650-433-2628 syoung@versartis.com

Locations
United States, California
AMCR Institute Inc. Recruiting
Escondido, California, United States, 92025
Contact: Shelby Young, RN, BS    650-433-2628    syoung@versartis.com   
Therapeutic Research Institute of Orange County Recruiting
Laguna Hills, California, United States, 92653
Contact: Shelby Young, RN, BS    650-433-2628    syoung@versartis.com   
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Shelby Young, RN, BS    650-433-2628    syoung@versartis.com   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Shelby Young, RN, BS    650-433-2628    syoung@versartis.com   
United States, Nevada
Palm Research Center Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Shelby Young, RN, BS    650-433-2628    syoung@versartis.com   
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact: Shelby Young, RN, BS    650-433-2628    syoung@versartis.com   
Australia, Queensland
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia, 4102
Contact: Shelby Young, RN, BS    650-433-2628    syoung@versartis.com   
Australia, Victoria
St Vincent's Hospital Recruiting
Fitzroy, Victoria, Australia, 3065
Contact: Shelby Young, RN, BS    650-433-2628    syoung@versartis.com   
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Shelby Young, RN, BS    650-433-2628    syoung@versartis.com   
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
Study First Received: March 16, 2016
Last Updated: August 3, 2016

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

ClinicalTrials.gov processed this record on July 24, 2017