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

Teva Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Growth Hormone-Deficiency

Treatments: Drug: somatropin; Drug: TV-1106

Study type: Interventional

Funder types: Industry

Identifiers

NCT02092077

TV1106-IMM-20001

2013-004468-69 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 65 patients

Sex: All

Ages: 3 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 4 patient groups

TV-1106 0.554 mg

Experimental group

Treatment:

Drug: TV-1106

TV-1106 0.924 mg/kg

Experimental group

Treatment:

Drug: TV-1106

TV-1106 1.20 mg/kg

Experimental group

Treatment:

Drug: TV-1106

somatropin 0.033 mg/kg/day

Active Comparator group

Description:

Dosages may be adjusted according to findings and as necessary

Treatment:

Drug: somatropin