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

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Growth Hormone-Deficiency

Intervention: TV-1106 (Drug); somatropin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Teva Pharmaceutical Industries

Official(s) and/or principal investigator(s):
Medical Director, MD, Study Director, Affiliation: TEVA

Overall contact:
Teva U.S. Medical Information, Phone: 1-800-896-5855

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Height velocity (HV)

Secondary outcome:

Height velocity standard deviation score (HV-SDS)

Height standard deviation score (H-SDS)

Number of participants with adverse events

Height velocity (HV)

Eligibility

Minimum age: 3 Years. Maximum age: 11 Years. Gender(s): Both.

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

Locations and Contacts

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

Additional Information

Starting date: April 2014
Last updated: August 21, 2015

Page last updated: August 23, 2015

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