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: Drug: TV-1106; Drug: somatropin

• 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

Study Timeline

• Study First Submitted: 2014-03-14
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-19
• Study Start: 2014-04-30
• Primary Completion: 2016-04-30
• Study Completion: 2016-08-31
• Disposition First Submitted: 2018-05-08
• Disposition First Submitted QC: 2018-05-08
• Disposition First Posted: 2018-05-11
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-09

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

Group	Intervention	Description
TV-1106 0.554 mg	TV-1106	-
somatropin 0.033 mg/kg/day	somatropin	Dosages may be adjusted according to findings and as necessary
TV-1106 0.924 mg/kg	TV-1106	-
TV-1106 1.20 mg/kg	TV-1106	-

Primary Outcome Measures

Name	Time	Method
Height velocity (HV)	Month 6

Secondary Outcome Measures

Name	Time	Method
Height velocity standard deviation score (HV-SDS)	Months 6 and 12
Height velocity (HV)	Month 12
Number of participants with adverse events	up 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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