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TV-1106

Phase 2

Growth Hormone Deficiency | Small molecule | Endocrine |Teva Pharmaceutical Industries Limited|Last Updated: Dec 10, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

TV-1106 · 1 trial · 1 indication

Phase 2 1
NCT01811576Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone DeficiencyGrowth Hormone Deficiency
COMPLETED52 Analytics
PHASE2COMPLETED
Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency
Growth Hormone DeficiencyUnlock trial analytics

Study Endpoints

Primary Endpoints

Insulin-like growth factor I (IGF-I) concentration change from baseline
Baseline to Week 12

Secondary Endpoints

Percentage of patients treated with TV1106 who return to pre-treatment IGF-1 SDS
Baseline to Week 12
Safety Parameters
78 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
recombinant human growth hormoneACTIVE_COMPARATORDaily subcutaneous dose
TV-1106EXPERIMENTALTitration dose levels of TV-1106

Interventions

NameTypeDescription
TV-1106DRUG -
Recombinant human growth hormoneDRUGSubcutaneous once daily
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Eligibility Criteria

Age Range23 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * Patient agrees to provide written informed consent and to comply with the study protocol after reading the informed consent and discussing the study with the investigator. * Males and females between 23 and 65 years of age must have a confirmed diagnosis of adult GHD, either a...

Countries:United StatesCzechiaGermanyGreeceHungaryIsraelSerbiaSlovakiaSlovenia
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Frequently asked questions about TV-1106

What is TV-1106 used for?

TV-1106 is an investigational small molecule being developed for the treatment of Growth Hormone Deficiency. It is intended to address this endocrine condition, which affects adults. The drug is currently in clinical development and has not been approved for use.

Who makes TV-1106?

TV-1106 is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker TEVA. The drug is currently in Phase 2 clinical development for Growth Hormone Deficiency.

What phase is TV-1106 in?

TV-1106 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 2 clinical trial for the drug has been completed, but it remains in the clinical development process.

What clinical trials is TV-1106 in?

TV-1106 has one completed Phase 2 clinical trial, identified as NCT01811576. This trial, titled "Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency," enrolled 52 participants across multiple countries including the United States, Czechia, Germany, Greece, Hungary, Israel, Serbia, Slovakia, and Slovenia.

Is TV-1106 the same as any other drug?

TV-1106 is a distinct investigational drug candidate developed by Teva Pharmaceutical Industries Limited. It is not known to be the same as any other marketed or approved medication. It is being studied specifically for Growth Hormone Deficiency.