Study of TV-1106 in Growth Hormone-Deficient Adults

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Brief Title

Study of TV-1106 in Growth Hormone-Deficient Adults

Official Title

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy, Safety and Tolerability Study of TV-1106 in Growth Hormone-Deficient Adults Who Are Not Current Users of rhGH Treatment

Brief Summary

      The primary objective of this study is to determine the efficacy of 6 months of treatment
      with TV-1106 compared with placebo on body fat composition.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Body Fat Mass at Baseline, Week 24 and Endpoint in Core Period

Secondary Outcome

 Total Trunk Fat at Baseline, Week 24 and Endpoint in Core Period

Condition

Growth Hormone Deficiency

Intervention

TV-1106

Study Arms / Comparison Groups

 Placebo
Description:  Placebo was injected subcutaneously once weekly on the same day and time for 24 weeks. To maintain the blind, placebo could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 to match the effect of dose titration.

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

14

Start Date

April 30, 2015

Completion Date

December 31, 2015

Primary Completion Date

December 31, 2015

Eligibility Criteria

        Inclusion:

          -  males and females 18 years of age or over

          -  diagnosis of adult growth hormone deficiency (GHD) for at least 6 months, or patients
             who have hypopituitarism from surgical resection

          -  no history of exposure to any rhGH within the past 12 months prior to screening

          -  stable, adequate doses of replacement hormones (adrenal, thyroid, estrogen,
             testosterone, vasopressin) for at least 3 months prior to screening

               -  Other criteria apply, please contact the investigator for more information

        Exclusion:

          -  patients with acute or chronic conditions or diseases that could confound results of
             the study or put the patient at undue risk as determined by the investigator

          -  Presence of contraindications to rhGH treatment

          -  patients who have participated in another clinical trial with a new
             chemical/biological entity within 3 months of screening

          -  patients with known active malignancy (excluding surgically removed basal cell
             carcinoma or carcinoma in situ of cervix)

          -  patients with a previously treated pituitary tumor with evidence of tumor progression
             in the past year patients with a new diagnosis of pituitary adenoma or other
             intracranial tumor within 12 months of screening

          -  presence of Prader-Willi syndrome, Turner's syndrome, untreated adrenal insufficiency,
             active acromegaly in the past 5 years, or active Cushing's syndrome in the past 1 year

          -  patients with type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus
             as indicated by a glycated hemoglobin (HBA1c) of ≥8%

          -  patients using weight reducing agents or appetite suppressants

          -  women who are pregnant or nursing, or planning pregnancy during the study period

               -  Other criteria apply, please contact the investigator for more information
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Teva Medical Expert, MD, , 

Location Countries

Austria

Location Countries

Austria

Administrative Informations


NCT ID

NCT02410343

Organization ID

TV1106-IMM-30021

Secondary IDs

2014-003796-32

Responsible Party

Sponsor

Study Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.


Study Sponsor

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


Verification Date

January 2022