Versartis Trial in Children to Assess Long-Acting Growth Hormone

NCT ID: NCT01718041

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-07-31

Brief 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.

Detailed Description

In Phase 1b, separate cohorts of patients will be tested in a single ascending dose format. Safety review committee meetings will take place prior to escalating to each increasing dose level. Enrolled patients will be monitored for 60 days for safety with PK/PD and safety labs collected.

Two dose levels will be selected after completion of Phase 1b to be tested during Phase 2a (6 months of continuous VRS-317 treatment). Safety and PK assessments will be made during the Phase 2a stage. Patient heights will be measured by stadiometer.

Conditions

Pediatric Growth Hormone Deficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VRS-317

Active treatment arm

Group Type: EXPERIMENTAL

Experimental: VRS-317

Intervention Type: DRUG

Active treatment arm

Interventions

Experimental: VRS-317

Active treatment arm

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Versartis Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clovis, California, United States

Los Angeles, California, United States

San Diego, California, United States

San Francisco, California, United States

Greenwood Village, Colorado, United States

Orlando, Florida, United States

Tallahassee, Florida, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Indianapolis, Indiana, United States

Baltimore, Maryland, United States

Springfield, Massachusetts, United States

Minneapolis, Minnesota, United States

Kansas City, Missouri, United States

Livingston, New Jersey, United States

Morristown, New Jersey, United States

Buffalo, New York, United States

Mineola, New York, United States

Sleepy Hollow, New York, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

San Antonio, Texas, United States

Seattle, Washington, United States

Countries

United States

Other Identifiers

VRS-317 Protocol 12VR2

Identifier Type: -

Identifier Source: org_study_id