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

• Status: Completed
• Trial end date: 2017-08-23
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Versartis Inc.
• Treatments: Hormones

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