A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children

A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children

The purpose of this study is to support selection of an appropriate safe and efficacious dose for study in further development.

Criteria for Inclusion:

• Pre-pubertal boys ≥ 3 years to ≤ 11 years and pre-pubertal girls ≥ 3 years to ≤ 10 years growth hormone (GH) insufficiency
• Diagnosis criteria consistent with growth hormone research society consensus guidelines
• Patients with a previously treated pituitary tumor must have no tumor progression for at least the past year
• Physician determined rate of change in height less than 2 standard deviations per age group.
• Written Informed Consent
• Parent or legal guardian who is capable and willing to administer the study drug.
• Other criteria apply, please contact the investigator for more information

Criteria for Exclusion:

• Any clinically significant medical condition as determined by the investigator, that is likely to affect growth
• Contraindications to rhGH treatment;
• History of or currently active malignancy, including pituitary tumors;
• Bone age, greater than chronological age or greater than 9 for girls or greater than 10 for boys within 3 months of screening.
• Patients with known diagnosis of diabetes or pre-diabetes
• Growth altering medications
• Allergies to the study medication components;
• Participation in another investigational study within 30 days of screening
• Any medical condition as judged by the investigator to interfere with patient participation or the objectives of the study
• Other criteria apply, please contact the investigator for more information