Versartis Trial in Children to Assess Long-Acting Growth Hormone

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1b/2a study of VRS-317 (long-acting growth hormone) in pediatric patients with growth hormone deficiency. During Phase 1b, pediatric patients each will receive a single subcutaneous injection of VRS-317. During the Phase 2a stage, patients will receive 6 months of VRS-317 treatment at dose levels selected from the Phase 1b stage. The primary endpoints for the study are to determine the safety and efficacy of repeat dose VRS-317.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Versartis Inc.
• Treatments: Hormones

Criteria

Inclusion Criteria:

• Chronological Age ≥ 3.0 years and ≤ 11.0

• Diagnosis of GHD as documented by GH stimulation test

• Below average height SDS at screening

• Appropriate weight for Stature

• Decreased IGF-I SDS at screening

• Delayed bone age

• Normal thyroid function test results at screening visit

• Legally authorized representative informed consent.

Exclusion Criteria:

• Prior treatment with any growth promoting agent

• Documented history of, or current, significant disease

• Chromosomal aneuploidy, significant gene mutations

• Diagnosis of Attention Deficit Hyperactivity Disorder

• Daily use of anti-inflammatory doses of glucocorticoid

• Prior history of leukemia, lymphoma, sarcoma or cancer

• Known allergy to constituents of the study drug formulation

• Abnormal ocular findings at screening

• Significant abnormality in screening laboratory studies