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Versartis Trial in Pre-pubertal Japanese Children With Growth Hormone Deficiency (GHD) to Assess Long-Acting Growth Hormone (Somavaratan, VRS-317)

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by Versartis Inc.
Sponsor:
Information provided by (Responsible Party):
Versartis Inc.
ClinicalTrials.gov Identifier:
NCT02413138
First received: March 23, 2015
Last updated: November 4, 2016
Last verified: November 2016
  Purpose
The trial will consist of three stages: 1) a 30 day Phase 2 PK and PD evaluation of somavaratan, 2) an optional Phase 2 Extension and 3) a 12 month Phase 3 safety and efficacy stage. Upon completion of the PK/PD stage, the PK/PD profiles for the GHD children in this study will be compared to the PK/PD profiles for the GHD children treated in the Western study Phase 1b/2a study (Protocol 12VR2) and identify the somavaratan dose to be used in the Phase 3 stage in Japan. The Phase 3 stage will continue dosing for 12 months to obtain safety and efficacy data on 48 subjects.

Condition Intervention Phase
Pediatric Growth Hormone Deficiency Growth Disorders Drug: Somavaratan (VRS-317) Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Phase 2/3, Open-Label, Multi-center Study of the Pharmacokinetics, Pharmacodynamics, Safety and Efficacy of A Long-acting Human Growth Hormone (Somavaratan, VRS-317) in Pre-pubertal Japanese Children With Growth Hormone Deficiency (GHD)

Resource links provided by NLM:


Further study details as provided by Versartis Inc.:

Primary Outcome Measures:
  • Efficacy (Annual Height velocity) [ Time Frame: 12 months ]
    Annual Height velocity.


Secondary Outcome Measures:
  • Pharmacodynamics (IGF-I responses to study drug administration) [ Time Frame: 12 months ]
    IGF-I responses to study drug administration.

  • Pharmacodynamics (IGFBP-3 responses to study drug administration) [ Time Frame: 12 months ]
    IGFBP-3 responses to study drug administration.

  • Safety (Number of subjects with adverse events ) [ Time Frame: 12 months ]
    Number of subjects with adverse events (including repeat dose immunogenicity).

  • Safety (Concomitant medications) [ Time Frame: 12 months ]
    Concomitant medications

  • Safety (Safety labs) [ Time Frame: 12 months ]
    Safety labs

  • Safety (Vital signs) [ Time Frame: 12 months ]
    Vital signs

  • Safety (Physical Exams) [ Time Frame: 12 months ]
    Physical Exams


Other Outcome Measures:
  • Secondary Efficacy (Change in height SDS) [ Time Frame: 12 months ]
    Change in height SDS.

  • Secondary Efficacy [ Time Frame: 12 months ]
    Change in body weight

  • Secondary Efficacy [ Time Frame: 12 months ]
    Change in body mass index.

  • Secondary Efficacy (Change in bone age) [ Time Frame: 12 months ]
    Change in bone age.

  • Secondary Efficacy (Change in pubertal staging.) [ Time Frame: 12 months ]
    Change in pubertal staging.


Estimated Enrollment: 48
Study Start Date: March 2015
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase 2: Somavaratan (VRS-317)
Active treatment arm
Drug: Somavaratan (VRS-317)
Long acting recombinant human growth hormone
Other Name: Long acting recombinant human growth hormone
Experimental: Phase 3: Somavaratan (VRS-317)
Somavaratan long acting recombinant human growth hormone administered subcutaneously twice-monthly
Drug: Somavaratan (VRS-317)
Long acting recombinant human growth hormone
Other Name: Long acting recombinant human growth hormone

Detailed Description:
The trial will consist of three stages: 1) a 30 day Phase 2 PK and PD evaluation of somavaratan, 2) an optional Phase 2 Extension and 3) a 12 month Phase 3 safety and efficacy stage. The study is a randomized, multi-center, open label study. The primary endpoint is height velocity at 12 months.
  Eligibility

Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronological Age ≥ 3.0 years and ≤ 9.0 years (girls) or ≤ 10.0 years (boys)
  • Pre-pubertal status
  • Diagnosis of GHD as documented by two or more GH stimulation test results
  • Height SD score ≤ -2.0 at screening
  • Weight for Stature ≥ 10th percentile
  • IGF-I SD score ≤ -1.0 at screening
  • Delayed bone age

Exclusion Criteria:

  • Prior treatment with any growth promoting agent
  • History of, or current, significant disease
  • Chromosomal aneuploidy, significant gene mutations (other than those that cause GHD) or confirmed diagnosis of a named syndrome
  • Birth weight and/or birth length less than 5th percentile for gestational age
  • A diagnosis of Attention Deficit Hyperactivity Disorder
  • Daily use of anti-inflammatory doses of glucocorticoid
  • Prior history of leukemia, lymphoma, sarcoma or cancer
  • Ocular findings suggestive of increased intracranial pressure and/or retinopathy at screening
  • Significant spinal abnormalities including scoliosis, kyphosis and spina bifida variants
  • Significant abnormality in screening laboratory studies
  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: NCT02413138

Contacts
Contact: Eric Humphriss, MBA 650.963.8587 ehumphriss@versartis.com
Contact: Marta Schumacher, MBA 650.433.2621 mschumacher@versartis.com

Locations
Japan
Akita University Hospital Recruiting
Akita, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2612    mschumacher@versartis.com   
Ehime University Hospital Recruiting
Ehime, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Fukuoka Children's Hospital Recruiting
Fukuoka, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Fukuoka University Hospital Recruiting
Fukuoka, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    (650) 433-2621    mschumacher@versartis.com   
Gunma University Hospital Recruiting
Gunma, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Hamamatsu University Hospital Recruiting
Hamamatsu, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Kure Medical Center Recruiting
Hiroshima, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Hokkaido University Hospital Recruiting
Hokkaido, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Morioka Children's Hospital Recruiting
Iwate, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    (650) 433-2621    mschumacher@versartis.com   
Kanagawa Prefectural Hospital Recruiting
Kanagawa, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Kanazawa Medical University Hospital Recruiting
Kanazawa, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Kumamoto University Hospital Recruiting
Kumamoto, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
University of Miyazaki Hospital Recruiting
Miyazaki, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    (650) 433-2621    mschumacher@versartis.com   
Aichi Children's Health and Medical Center Recruiting
Nagoya, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Nagoya City University Hospital Recruiting
Nagoya, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Niigata University Medical and Dental Hospital Recruiting
Niigata, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Oita University Hospital Recruiting
Oita, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Okayama Saiseikai General Hospital Recruiting
Okayama, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Japan Community Health care Organization Osaka Hospital Recruiting
Osaka, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Osaka City General Hospital Recruiting
Osaka, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Osaka Medical Center and Reserach Institute for Maternal and Child Health Recruiting
Osaka, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Osaka Police Hospital Recruiting
Osaka, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    (650) 433-2621    mschumacher@versartis.com   
Osaka University Hospital Recruiting
Osaka, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Saitama Children's Medical Center Recruiting
Saitama, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Shiga University of Medical Science Hospital Recruiting
Shiga, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Keio University Hospital Recruiting
Tokyo, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
National Center for Child Health and Development Recruiting
Tokyo, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Nihon University Hospital Recruiting
Tokyo, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Saitama Medical University Hospital Recruiting
Tokyo, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Tanaka Growth Clinic Recruiting
Tokyo, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher       mschumacher@versartis.com   
The Jikei University Hospital Recruiting
Tokyo, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Tohoku University Hospital Recruiting
Tokyo, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Tokyo Medical and Dental University Recruiting
Tokyo, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Tokyo Metropolitan Children's Medical Center Recruiting
Tokyo, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Toranomon Hospital Recruiting
Tokyo, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Tottori University Hosptial Recruiting
Tottori, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    650.433.2621    mschumacher@versartis.com   
Iwakuni Medical Center Recruiting
Yamaguchi, Japan
Contact: Yuji Hoshino, MD       yhoshino@versartis.com   
Contact: Marta Schumacher    (650) 433-2621    mschumacher@versartis.com   
Sponsors and Collaborators
Versartis Inc.
Investigators
Principal Investigator: Tomonobu Hasegawa, MD Keio University Hospital
  More Information

Responsible Party: Versartis Inc.
ClinicalTrials.gov Identifier: NCT02413138     History of Changes
Other Study ID Numbers: J14VR5
Study First Received: March 23, 2015
Last Updated: November 4, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Versartis Inc.:
GHD

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
Growth Disorders
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
Pathologic Processes
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2017