The purpose of this study is to support selection of an appropriate safe and efficacious
dose for study in further development.
Minimum age: 3 Years.
Maximum age: 11 Years.
Gender(s): Both.
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
Teva U.S. Medical Information, Phone: 1-800-896-5855
Teva Investigational Site 68016, Minsk, Belarus; Recruiting
Teva Investigational Site 59060, Varna, Bulgaria; Recruiting
Teva Investigational Site 54106, Brno, Czech Republic; Recruiting
Teva Investigational Site 54105, Praha 5- Motol, Czech Republic; Not yet recruiting
Teva Investigational Site 81022, Tbilisi, Georgia; Recruiting
Teva Investigational Site 81023, Tbilisi, Georgia; Recruiting
Teva Investigational Site 81025, Tbilisi, Georgia; Recruiting
Teva Investigational Site 63046, Athens, Greece; Recruiting
Teva Investigational Site 63052, Thessaloniki, Greece; Recruiting
Teva Investigational Site 51159, Budapest, Hungary; Recruiting
Teva Investigational Site 51160, Budapest, Hungary; Recruiting
Teva Investigational Site 51161, Budapest, Hungary; Recruiting
Teva Investigational Site 51183, Gyor, Hungary; Recruiting
Teva Investigational Site 51182, Hodmezovasarhely, Hungary; Recruiting
Teva Investigational Site 51180, Miskolc, Hungary; Recruiting
Teva Investigational Site 51162, Szeged, Hungary; Recruiting
Teva Investigational Site 51181, Szombathely, Hungary; Recruiting
Teva Investigational Site 80052, Afula, Israel; Recruiting
Teva Investigational Site 80055, Beer Sheva, Israel; Recruiting
Teva Investigational Site 80054, Holon, Israel; Recruiting
Teva Investigational Site 80053, Petach Tikva, Israel; Recruiting
Teva Investigational Site 80056, Ramat Gan, Israel; Recruiting
Teva Investigational Site 53215, Katowice, Poland; Not yet recruiting
Teva Investigational Site 53212, Lublin, Poland; Not yet recruiting
Teva Investigational Site 53214, Rzeszow, Poland; Recruiting
Teva Investigational Site 53216, Warszawa, Poland; Not yet recruiting
Teva Investigational Site 53244, Wroclaw, Poland; Recruiting
Teva Investigational Site 53213, Zabrze, Poland; Not yet recruiting
Teva Investigational Site 52059, Cluj Napoca, Romania; Recruiting
Teva Investigational Site 52060, Tg. Mures, Romania; Recruiting
Teva Investigational Site 52056, Timisoara, Romania; Recruiting
Teva Investigational Site 50269, Ekaterinburg, Russian Federation; Not yet recruiting
Teva Investigational Site 50261, Izhevsk, Russian Federation; Recruiting
Teva Investigational Site 50260, Kazan, Russian Federation; Recruiting
Teva Investigational Site 50258, Moscow, Russian Federation; Recruiting
Teva Investigational Site 50259, Moscow, Russian Federation; Recruiting
Teva Investigational Site 50264, Novosibirsk, Russian Federation; Recruiting
Teva Investigational Site 50267, Saint-Petersburg, Russian Federation; Recruiting
Teva Investigational Site 50268, Samara, Russian Federation; Recruiting
Teva Investigational Site 50263, Saratov, Russian Federation; Recruiting
Teva Investigational Site 50262, Tomsk, Russian Federation; Recruiting
Teva Investigational Site 50265, Ufa, Russian Federation; Recruiting
Teva Investigational Site 61030, Belgrade, Serbia; Recruiting
Teva Investigational Site 61031, Belgrade, Serbia; Recruiting
Teva Investigational Site 61032, Nis, Serbia; Recruiting
Teva Investigational Site 64021, Ljubljana, Slovenia; Not yet recruiting
Teva Investigational Site 31098, Barcelona, Spain; Not yet recruiting
Teva Investigational Site 31099, Girona, Spain; Recruiting
Teva Investigational Site 82011, Ankara, Turkey; Recruiting
Teva Investigational Site 82013, Aydın, Turkey; Recruiting
Teva Investigational Site 82009, Istanbul, Turkey; Not yet recruiting
Teva Investigational Site 82010, Istanbul, Turkey; Not yet recruiting
Teva Investigational Site 82012, Izmir, Turkey; Recruiting
Teva Investigational Site 58141, Donetsk, Ukraine; Not yet recruiting
Teva Investigational Site 58138, Kharkiv, Ukraine; Recruiting
Teva Investigational Site 58140, Kiev, Ukraine; Recruiting
Teva Investigational Site 58139, Kyiv, Ukraine; Recruiting
Teva Investigational Site 58142, Odessa, Ukraine; Recruiting