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

Phase 2
Terminated
Conditions
Growth Hormone-Deficiency
Interventions
Registration Number
NCT02092077
Lead Sponsor
Teva Pharmaceutical Industries, Ltd.
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
65
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
TV-1106 0.554 mgTV-1106-
somatropin 0.033 mg/kg/daysomatropinDosages may be adjusted according to findings and as necessary
TV-1106 0.924 mg/kgTV-1106-
TV-1106 1.20 mg/kgTV-1106-
Primary Outcome Measures
NameTimeMethod
Height velocity (HV)Month 6
Secondary Outcome Measures
NameTimeMethod
Height velocity standard deviation score (HV-SDS)Months 6 and 12
Height velocity (HV)Month 12
Number of participants with adverse eventsup to 24 months
Height standard deviation score (H-SDS)Months 6 and 12

Trial Locations

Locations (34)

Teva Investigational Site 68016

🇧🇾

Minsk, Belarus

Teva Investigational Site 59060

🇧🇬

Varna, Bulgaria

Teva Investigational Site 81022

🇬🇪

Tbilisi, Georgia

Teva Investigational Site 81023

🇬🇪

Tbilisi, Georgia

Teva Investigational Site 81025

🇬🇪

Tbilisi, Georgia

Teva Investigational Site 63046

🇬🇷

Athens, Greece

Teva Investigational Site 51159

🇭🇺

Budapest, Hungary

Teva Investigational Site 51160

🇭🇺

Budapest, Hungary

Teva Investigational Site 51181

🇭🇺

Szombathely, Hungary

Teva Investigational Site 80052

🇮🇱

Afula, Israel

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Teva Investigational Site 68016
🇧🇾Minsk, Belarus

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