A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children
NCT ID: NCT02092077
Last Updated: 2021-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
65 participants
INTERVENTIONAL
2014-04-30
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TV-1106 0.554 mg
TV-1106
TV-1106 0.554mg, TV-1106 0.924 mg, TV-1106 1.20 mg
TV-1106 0.924 mg/kg
TV-1106
TV-1106 0.554mg, TV-1106 0.924 mg, TV-1106 1.20 mg
TV-1106 1.20 mg/kg
TV-1106
TV-1106 0.554mg, TV-1106 0.924 mg, TV-1106 1.20 mg
somatropin 0.033 mg/kg/day
Dosages may be adjusted according to findings and as necessary
somatropin
Dose may be adjusted as required
Interventions
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TV-1106
TV-1106 0.554mg, TV-1106 0.924 mg, TV-1106 1.20 mg
somatropin
Dose may be adjusted as required
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
3 Years
11 Years
ALL
No
Sponsors
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Teva Pharmaceutical Industries, Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director, MD
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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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
Teva Investigational Site 80055
Beersheba, , Israel
Teva Investigational Site 80053
Petah Tikva, , Israel
Teva Investigational Site 80056
Ramat Gan, , Israel
Teva Investigational Site 53216
Warsaw, , Poland
Teva Investigational Site 52056
Timișoara, , Romania
Teva Investigational Site 50261
Izhevsk, , Russia
Teva Investigational Site 50260
Kazan', , Russia
Teva Investigational Site 50258
Moscow, , Russia
Teva Investigational Site 50259
Moscow, , Russia
Teva Investigational Site 50264
Novosibirsk, , Russia
Teva Investigational Site 50267
Saint Petersburg, , Russia
Teva Investigational Site 50268
Samara, , Russia
Teva Investigational Site 50263
Saratov, , Russia
Teva Investigational Site 50262
Tomsk, , Russia
Teva Investigational Site 50265
Ufa, , Russia
Teva Investigational Site 61030
Belgrade, , Serbia
Teva Investigational Site 61032
Niš, , Serbia
Teva Investigational Site 31099
Girona, , Spain
Teva Investigational Site 82011
Ankara, , Turkey (Türkiye)
Teva Investigational Site 82013
Aydin, , Turkey (Türkiye)
Teva Investigational Site 58138
Kharkiv, , Ukraine
Teva Investigational Site 58140
Kiev, , Ukraine
Teva Investigational Site 58139
Kyiv, , Ukraine
Teva Investigational Site 58142
Odesa, , Ukraine
Countries
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Other Identifiers
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2013-004468-69
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TV1106-IMM-20001
Identifier Type: -
Identifier Source: org_study_id