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

Sponsor
Teva Pharmaceutical Industries, Ltd. (Industry)
Overall Status
Terminated
CT.gov ID
NCT02092077
Collaborator
(none)
65
Enrollment
34
Locations
4
Arms
28.1
Actual Duration (Months)
1.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 30, 2014
Actual Primary Completion Date :
Apr 30, 2016
Actual Study Completion Date :
Aug 31, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: TV-1106 0.554 mg

Drug: TV-1106
TV-1106 0.554mg, TV-1106 0.924 mg, TV-1106 1.20 mg
Other Names:
  • albutropin
  • Human Growth Hormone Therapy

    		•
    Experimental: TV-1106 0.924 mg/kg

    Drug: TV-1106
    TV-1106 0.554mg, TV-1106 0.924 mg, TV-1106 1.20 mg
    Other Names:
  • albutropin
  • Human Growth Hormone Therapy

    		•
    Experimental: TV-1106 1.20 mg/kg

    Drug: TV-1106
    TV-1106 0.554mg, TV-1106 0.924 mg, TV-1106 1.20 mg
    Other Names:
  • albutropin
  • Human Growth Hormone Therapy

    		•
    Active Comparator: somatropin 0.033 mg/kg/day

    Dosages may be adjusted according to findings and as necessary

    Drug: somatropin
    Dose may be adjusted as required
    Other Names:
  • Human Growth Hormone Therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Height velocity (HV) [Month 6]

    Secondary Outcome Measures

    1. Height velocity standard deviation score (HV-SDS) [Months 6 and 12]

    2. Height standard deviation score (H-SDS) [Months 6 and 12]

    3. Number of participants with adverse events [up to 24 months]

    4. Height velocity (HV) [Month 12]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 11 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Teva Investigational Site 68016 Minsk Belarus
    2 Teva Investigational Site 59060 Varna Bulgaria
    3 Teva Investigational Site 81022 Tbilisi Georgia
    4 Teva Investigational Site 81023 Tbilisi Georgia
    5 Teva Investigational Site 81025 Tbilisi Georgia
    6 Teva Investigational Site 63046 Athens Greece
    7 Teva Investigational Site 51159 Budapest Hungary
    8 Teva Investigational Site 51160 Budapest Hungary
    9 Teva Investigational Site 51181 Szombathely Hungary
    10 Teva Investigational Site 80052 Afula Israel
    11 Teva Investigational Site 80055 Beer Sheva Israel
    12 Teva Investigational Site 80053 Petach Tikva Israel
    13 Teva Investigational Site 80056 Ramat Gan Israel
    14 Teva Investigational Site 53216 Warszawa Poland
    15 Teva Investigational Site 52056 Timisoara Romania
    16 Teva Investigational Site 50261 Izhevsk Russian Federation
    17 Teva Investigational Site 50260 Kazan Russian Federation
    18 Teva Investigational Site 50258 Moscow Russian Federation
    19 Teva Investigational Site 50259 Moscow Russian Federation
    20 Teva Investigational Site 50264 Novosibirsk Russian Federation
    21 Teva Investigational Site 50267 Saint-Petersburg Russian Federation
    22 Teva Investigational Site 50268 Samara Russian Federation
    23 Teva Investigational Site 50263 Saratov Russian Federation
    24 Teva Investigational Site 50262 Tomsk Russian Federation
    25 Teva Investigational Site 50265 Ufa Russian Federation
    26 Teva Investigational Site 61030 Belgrade Serbia
    27 Teva Investigational Site 61032 Nis Serbia
    28 Teva Investigational Site 31099 Girona Spain
    29 Teva Investigational Site 82011 Ankara Turkey
    30 Teva Investigational Site 82013 Aydın Turkey
    31 Teva Investigational Site 58138 Kharkiv Ukraine
    32 Teva Investigational Site 58140 Kiev Ukraine
    33 Teva Investigational Site 58139 Kyiv Ukraine
    34 Teva Investigational Site 58142 Odessa Ukraine

    Sponsors and Collaborators

    • Teva Pharmaceutical Industries, Ltd.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Teva Pharmaceutical Industries, Ltd.
    ClinicalTrials.gov Identifier:
    NCT02092077
    Other Study ID Numbers:
    • TV1106-IMM-20001
    • 2013-004468-69
    First Posted:
    Mar 19, 2014
    Last Update Posted:
    Nov 9, 2021
    Last Verified:
    Nov 1, 2021
    Keywords provided by Teva Pharmaceutical Industries, Ltd.
    Growth Hormone-Deficient
    recombinant human growth hormone
    Additional relevant MeSH terms:
    Hormones

    Study Results

    No Results Posted as of Nov 9, 2021