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

• Status: Terminated
• Trial end date: 2016-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Teva Pharmaceutical Industries; Teva Pharmaceutical Industries, Ltd.
• Treatments: Hormones

Criteria

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