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

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Brief Title

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

Official Title

A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children

Brief Summary

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


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Height velocity (HV)

Secondary Outcome

 Height velocity standard deviation score (HV-SDS)

Condition

Growth Hormone-Deficiency

Intervention

TV-1106

Study Arms / Comparison Groups

 TV-1106 0.554 mg
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

65

Start Date

April 30, 2014

Completion Date

August 31, 2016

Primary Completion Date

April 30, 2016

Eligibility 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
      

Gender

All

Ages

3 Years - 11 Years

Accepts Healthy Volunteers

No

Contacts

Medical Director, MD, , 

Location Countries

Belarus

Location Countries

Belarus

Administrative Informations


NCT ID

NCT02092077

Organization ID

TV1106-IMM-20001

Secondary IDs

2013-004468-69

Responsible Party

Sponsor

Study Sponsor

Teva Pharmaceutical Industries, Ltd.


Study Sponsor

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


Verification Date

November 2021