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

NCT02092077 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2021-11-09

No results posted yet for this study

Summary

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

Conditions

  • Growth Hormone-Deficiency

Interventions

DRUG

TV-1106

TV-1106 0.554mg, TV-1106 0.924 mg, TV-1106 1.20 mg

DRUG

somatropin

Dose may be adjusted as required

Sponsors & Collaborators

  • Teva Pharmaceutical Industries, Ltd.

    lead INDUSTRY

Principal Investigators

  • Medical Director, MD · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-04-30
Completion
2016-08-31

Countries

  • Belarus
  • Bulgaria
  • Georgia
  • Greece
  • Hungary
  • Israel
  • Poland
  • Romania
  • Russia
  • Serbia
  • Spain
  • Turkey (Türkiye)
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02092077 on ClinicalTrials.gov