Growth Hormone-Deficiency Clinical Trial
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
| Verified date | November 2021 |
| Source | Teva Branded Pharmaceutical Products R&D, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to support selection of an appropriate safe and efficacious dose for study in further development.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Teva Pharmaceutical Industries, Ltd. |
Belarus, Bulgaria, Georgia, Greece, Hungary, Israel, Poland, Romania, Russian Federation, Serbia, Spain, Turkey, Ukraine,
| 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 |