Comparison of Long-acting Growth Hormone VRS-317 to Daily Growth Hormone in Pediatric GHD Patients
Information source: Versartis Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Growth Disorders
Intervention: VRS-317 (Drug); Daily rhGH (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Versartis Inc. Official(s) and/or principal investigator(s):
George M Bright, MD, Study Director, Affiliation: Sponsor GmbH
Overall contact:
Eric Humphriss, MBA, Phone: 650-963-8587, Email: ehumphriss@versartis.com
Summary
The trial will compare a semi-monthly VRS-317 dosing regimen for non-inferiority of
treatment effect against daily injections of rhGH.
Clinical Details
Official title: Comparison of VRS-317, a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children With Growth Hormone Deficiency.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Efficacy (Annual height velocity)
Secondary outcome: Pharmacodynamics (IGF-I and IGFBP-3 responses to study drug administration)Safety as measured by he number of patients with adverse events, concomitant medications, safety labs, vital signs, physical exams, and repeat dose immunogenicity.
Detailed description:
This study is designed as a pivotal study to compare the safety and efficacy of a selected
dose regimen of VRS-317 to daily rhGH. The study is a randomized, multi-center, open label
study of 12 months duration. The primary endpoint is height velocity at 12 months.
Eligibility
Minimum age: 3 Years.
Maximum age: 11 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Chronological Age ≥ 3. 0 years and ≤ 10. 0 (girls) and ≤ 11. 0 (boys).
- Pre-pubertal status: Absent breast development in girls, testicular volume < 4. 0 mL
in boys.
- Diagnosis of GHD as documented by two or more GH stimulation test results ≤ 10. 0
ng/mL.
- Height SD score ≤ -2. 0 at screening.
- Weight for Stature ≥ 10th percentile.
- IGF-I SD score ≤ -1. 0 at screening.
- Delayed bone age (≥ 6 months).
Exclusion Criteria:
- Prior treatment with any growth promoting agent
- History of or concurrent significant disease (e. g. diabetes, cystic fibrosis, renal
insufficiency).
- Chromosomal aneuploidy, significant gene mutations (other than those that cause GHD)
or confirmed diagnosis of a named syndrome.
- A diagnosis of Attention Deficit Hyperactivity Disorder.
- Daily use of anti-inflammatory doses of glucocorticoid.
- Prior history of leukemia, lymphoma, sarcoma or cancer.
- Treatment with an investigational drug in the 30 days prior to screening.
- Known allergy to constituents of the study drug formulation.
- 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
Locations and Contacts
Eric Humphriss, MBA, Phone: 650-963-8587, Email: ehumphriss@versartis.com
Tallahassee, Florida, United States; Recruiting
Eric Humphriss, MBA, Phone: 650-963-8587, Email: ehumphriss@versartis.com
Naureen Sheikh, PhD, Phone: 650-433-2613, Email: nsheikh@versartis.com
Additional Information
Starting date: January 2015
Last updated: August 12, 2015
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