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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02092077
Other study ID # TV1106-IMM-20001
Secondary ID 2013-004468-69
Status Terminated
Phase Phase 2
First received
Last updated
Start date April 30, 2014
Est. completion date August 31, 2016

Study information

Verified date November 2021
Source Teva Branded Pharmaceutical Products R&D, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Terminated
Enrollment 65
Est. completion date August 31, 2016
Est. primary completion date April 30, 2016
Accepts healthy volunteers No
Gender All
Age group 3 Years to 11 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
TV-1106
TV-1106 0.554mg, TV-1106 0.924 mg, TV-1106 1.20 mg
somatropin
Dose may be adjusted as required

Locations

Country Name City State
Belarus Teva Investigational Site 68016 Minsk
Bulgaria Teva Investigational Site 59060 Varna
Georgia Teva Investigational Site 81022 Tbilisi
Georgia Teva Investigational Site 81023 Tbilisi
Georgia Teva Investigational Site 81025 Tbilisi
Greece Teva Investigational Site 63046 Athens
Hungary Teva Investigational Site 51159 Budapest
Hungary Teva Investigational Site 51160 Budapest
Hungary Teva Investigational Site 51181 Szombathely
Israel Teva Investigational Site 80052 Afula
Israel Teva Investigational Site 80055 Beer Sheva
Israel Teva Investigational Site 80053 Petach Tikva
Israel Teva Investigational Site 80056 Ramat Gan
Poland Teva Investigational Site 53216 Warszawa
Romania Teva Investigational Site 52056 Timisoara
Russian Federation Teva Investigational Site 50261 Izhevsk
Russian Federation Teva Investigational Site 50260 Kazan
Russian Federation Teva Investigational Site 50258 Moscow
Russian Federation Teva Investigational Site 50259 Moscow
Russian Federation Teva Investigational Site 50264 Novosibirsk
Russian Federation Teva Investigational Site 50267 Saint-Petersburg
Russian Federation Teva Investigational Site 50268 Samara
Russian Federation Teva Investigational Site 50263 Saratov
Russian Federation Teva Investigational Site 50262 Tomsk
Russian Federation Teva Investigational Site 50265 Ufa
Serbia Teva Investigational Site 61030 Belgrade
Serbia Teva Investigational Site 61032 Nis
Spain Teva Investigational Site 31099 Girona
Turkey Teva Investigational Site 82011 Ankara
Turkey Teva Investigational Site 82013 Aydin
Ukraine Teva Investigational Site 58138 Kharkiv
Ukraine Teva Investigational Site 58140 Kiev
Ukraine Teva Investigational Site 58139 Kyiv
Ukraine Teva Investigational Site 58142 Odessa

Sponsors (1)

Lead Sponsor Collaborator
Teva Pharmaceutical Industries, Ltd.

Countries where clinical trial is conducted

Belarus,  Bulgaria,  Georgia,  Greece,  Hungary,  Israel,  Poland,  Romania,  Russian Federation,  Serbia,  Spain,  Turkey,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Height velocity (HV) Month 6
Secondary Height velocity standard deviation score (HV-SDS) Months 6 and 12
Secondary Height standard deviation score (H-SDS) Months 6 and 12
Secondary Number of participants with adverse events up to 24 months
Secondary Height velocity (HV) Month 12