Versartis Long-Acting Growth Hormone in Children Compared to Daily rhGH



Status:Completed
Conditions:Endocrine, Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:3 - 11
Updated:10/15/2017
Start Date:August 24, 2015
End Date:August 23, 2017

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Comparison of Somavaratan (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.

The trial will compare a twice-monthly somavaratan dosing regimen for non-inferiority of
treatment effect against daily injections of rhGH.

This study is designed as a pivotal study to compare the safety and efficacy of a selected
dose regimen of somavaratan 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.

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
We found this trial at
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259 1st St
Mineola, New York 11501
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Cleveland, Ohio 44106
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807 Childrens Way
Jacksonville, Florida 32207
(904) 697-3600
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Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
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Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
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Minneapolis, Minnesota 55455
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South 34th Street
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
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3020 Childrens way
San Diego, California 92123
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
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Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Brussels,
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Centennial, Colorado 80112
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171 Ashley Avenue
Charleston, South Carolina 29425
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Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
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Clovis, California 93612
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1801 Inwood Rd
Dallas, Texas 75390
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Indianapolis, Indiana 46202
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New Haven, Connecticut 6520
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940 NE 13th St
Oklahoma City, Oklahoma 73190
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Orlando, Florida 32806
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759 Chestnut Street
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314 Martin Luther King Junior Way
Tacoma, Washington 98405
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Tallahassee, Florida 32308
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