Clinical trial NCT02092077: A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Growth Hormone-Deficiency
Keywords: Growth Hormone-Deficient
recombinant human growth hormone
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-19
Enrollment: 65
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Height velocity (HV)
timeFrame: Month 6
Secondary outcomes:
measure: Height velocity standard deviation score (HV-SDS)
timeFrame: Months 6 and 12
measure: Height standard deviation score (H-SDS)
timeFrame: Months 6 and 12
measure: Number of participants with adverse events
timeFrame: up to 24 months
measure: Height velocity (HV)
timeFrame: Month 12
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Teva Investigational Site 68016
city: Varna
country: Bulgaria
facility: Teva Investigational Site 59060
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81022
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81023
city: Tbilisi
country: Georgia
facility: Teva Investigational Site 81025
city: Athens
country: Greece
facility: Teva Investigational Site 63046
city: Budapest
country: Hungary
facility: Teva Investigational Site 51159
city: Budapest
country: Hungary
facility: Teva Investigational Site 51160
city: Szombathely
country: Hungary
facility: Teva Investigational Site 51181
city: Afula
country: Israel
facility: Teva Investigational Site 80052
city: Beer Sheva
country: Israel
facility: Teva Investigational Site 80055
city: Petach Tikva
country: Israel
facility: Teva Investigational Site 80053
city: Ramat Gan
country: Israel
facility: Teva Investigational Site 80056
city: Warszawa
country: Poland
facility: Teva Investigational Site 53216
city: Timisoara
country: Romania
facility: Teva Investigational Site 52056
city: Izhevsk
country: Russian Federation
facility: Teva Investigational Site 50261
city: Kazan
country: Russian Federation
facility: Teva Investigational Site 50260
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 50258
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 50259
city: Novosibirsk
country: Russian Federation
facility: Teva Investigational Site 50264
city: Saint-Petersburg
country: Russian Federation
facility: Teva Investigational Site 50267
city: Samara
country: Russian Federation
facility: Teva Investigational Site 50268
city: Saratov
country: Russian Federation
facility: Teva Investigational Site 50263
city: Tomsk
country: Russian Federation
facility: Teva Investigational Site 50262
city: Ufa
country: Russian Federation
facility: Teva Investigational Site 50265
city: Belgrade
country: Serbia
facility: Teva Investigational Site 61030
city: Nis
country: Serbia
facility: Teva Investigational Site 61032
city: Girona
country: Spain
facility: Teva Investigational Site 31099
city: Ankara
country: Turkey
facility: Teva Investigational Site 82011
city: Aydın
country: Turkey
facility: Teva Investigational Site 82013
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 58138
city: Kiev
country: Ukraine
facility: Teva Investigational Site 58140
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58139
city: Odessa
country: Ukraine
facility: Teva Investigational Site 58142
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Medical Director, MD
role: STUDY_DIRECTOR
References: