Versartis Long-Term Safety Study of Somavaratan

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02068521
• Date of registration: 06/02/2014
• Prospective Registration: Yes
• Primary sponsor: Versartis Inc.
• Public title: Versartis Long-Term Safety Study of Somavaratan VISTA
• Scientific title: An Open-Label, Long-Term Safety Study of A Long-acting Human Growth Hormone Somavaratan (VRS-317) in Children With Growth Hormone Deficiency
• Date of first enrolment: March 3, 2014
• Target sample size: 385
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02068521
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2/Phase 3

Countries of recruitment

United States

Contacts

• Name: Will Charlton, MD
• Affiliation: Versartis Inc.

Key inclusion & exclusion criteria

Inclusion Criteria for Subjects Completing a Previous Somavaratan Study:

1. Completion of a somavaratan clinical study.

2. Willing and able to comply with all study procedures.

Exclusion Criteria for Subjects Completing a Previous somavaratan Study:

1. Withdrawal from a somavaratan clinical study.

2. Use of certain medications with potential to alter responses to the test product.

3. Presence of a significant medical condition.

Inclusion Criteria for New Treatment Naïve Subjects:

1. Chronological Age = 3.0 years.

2. Pre-pubertal status.

3. Diagnosis of GHD as documented by two or more GH stimulation test results = 10.0
ng/mL.

4. Normal thyroid function at Screening Visit in subjects not being treated for
hypothyroidism.

5. Normal adrenal function at Screening Visit or within 6 months of the Screening Visit,
in subjects not being treated for adrenal insufficiency. Subjects with adrenal
insufficiency must receive glucocorticoid treatment for a minimum of 4 weeks before
study drug administration.

6. Pathology relating to cause of GHD must be stable for at least 6 months prior to
screening.

7. Legally authorized representatives must be willing and able to give informed consent.

Exclusion Criteria for New Treatment Naïve Subjects:

1. Prior/concomitant treatment with any growth promoting agent.

2. Current, significant disease.

3. Chromosomal aneuploidy, significant gene mutations or confirmed diagnosis of a named
syndrome.

4. Birth weight and/or birth length less than 5th percentile for gestational age.

5. Prolonged daily use of anti-inflammatory doses of oral glucocorticoids.

6. Prior history of malignancy.

7. Treatment with an investigational drug in the 30 days prior to screening.

8. Known allergy to constituents of the study drug formulation.

9. Ocular findings suggestive of increased intracranial pressure and/or retinopathy at
screening.

10. Significant spinal abnormalities including scoliosis, kyphosis, Chiari malformation,
and spina bifida variants.

11. Significant abnormality in screening studies.

12. History of pancreatitis or undiagnosed chronic abdominal pain.

13. History of spinal or total body irradiation.

14. Other pituitary hormone deficiencies that are not properly treated.



Age minimum: 3 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pediatric Growth Hormone Deficiency

Intervention(s)

Drug: somavaratan

Primary Outcome(s)

Safety [Time Frame: Up to 4 years]

Secondary ID(s)

13VR3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors