- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03145831
A Long-Term Safety Study of Somavaratan in Japanese Children With Growth Hormone Deficiency
An Open-Label, Long-Term Safety Study of Long-acting Human Growth Hormone Somavaratan (VRS-317) in Japanese Children With Growth Hormone Deficiency
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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California
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Menlo Park, California, United States, 94025
- Eric Humphriss
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Chronological Age ≥ 3.0 years.
- Pre-pubertal status: Absent breast development in girls, testicular volume < 4.0 mL in boys.
- Subjects with GHD (diagnosed according to the current diagnostic guidelines) who are receiving treatment with daily rhGH.
- Normal thyroid function at screening visit in subjects not being treated for hypothyroidism. Subjects requiring thyroxine replacement must be considered adequately treated by the PI and Medical Monitor.
- Normal adrenal function (morning cortisol and/or local stimulation test) at screening visit or within 6 months of the screening visit, in subjects not being treated for adrenal insufficiency. Subjects with adrenal insufficiency must receive glucocorticoid treatment for a minimum of 4 weeks before study drug administration.
- Pathology relating to cause of GHD must be stable for at least 6 months prior to screening.
- Willingness to discontinue daily rhGH therapy.
- Legally authorized representatives must be willing and able to give informed consent
Exclusion Criteria:
1. Prior (in the last 12 months) or concomitant treatment with a growth promoting agent other than rhGH [e.g., IGF-I, GH releasing hormone (GHRH), sex steroids (except when used as primer for GH stimulation test), aromatase inhibitors and/or GnRH agonist].
2. Current significant disease (e.g., diabetes, cystic fibrosis, renal insufficiency). In all cases of concurrent disease, screening must be approved in writing by the medical monitor.
3. Chromosomal aneuploidy, significant gene mutations (other than those that cause GHD) or confirmed diagnosis of a named syndrome (e.g., Russell Silver, Prader Willi, Turner, etc.).
4. Birth weight and/or birth length less than 5th percentile for gestational age using local gestational age growth charts.
5. Prolonged daily (> 14 days) use of anti-inflammatory doses of oral glucocorticoids.
6. Prior history of malignancy. 7. Treatment with an investigational drug in the 30 days prior to screening. 8. Known allergy to constituents of the study drug formulation. 9. Ocular findings suggestive of increased intracranial pressure and/or retinopathy at screening.
10. Significant spinal abnormalities including scoliosis, kyphosis, Chiari malformation, and spina bifida variants.
11. Significant abnormality in screening laboratory studies (as assessed by PI and medical monitor).
12. Current social conditions which would prevent completion of study activities (e.g., planned family move to a distant location).
13. History of pancreatitis or undiagnosed chronic abdominal pain. 14. History of spinal or total body irradiation. 15. Presence of other pituitary hormone deficiencies that are not properly treated.
16. Unwillingness to provide consent for participation in all trial activities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Somavaratan
fusion protein, subcutaneous bolus injection, 3.5 mg/kg twice monthly
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All subjects will receive somavaratan 3.5 mg/kg twice monthly (every 15 days ± 2 days).
Administered as a subcutaneous bolus injection.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: 12 months
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Incidence and severity of adverse events
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Height velocity
Time Frame: 12 months
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Comparison of Height Velocity (HV) and HV-SDS before and after switching therapy
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12 months
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IGF-I expression
Time Frame: 12 months
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Change from Day 1
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12 months
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Immunogenicity
Time Frame: 12 months
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Evaluated by anti-drug antibody response
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Will Charlton, MD, Vesrartis
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- J15VR6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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