Study Stopped
Business decision
A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children
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
2 other identifiers
interventional
65
13 countries
34
Brief Summary
The purpose of this study is to support selection of an appropriate safe and efficacious dose for study in further development.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2014
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2014
CompletedFirst Posted
Study publicly available on registry
March 19, 2014
CompletedStudy Start
First participant enrolled
April 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2016
CompletedNovember 9, 2021
November 1, 2021
2 years
March 14, 2014
November 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Height velocity (HV)
Month 6
Secondary Outcomes (4)
Height velocity standard deviation score (HV-SDS)
Months 6 and 12
Height standard deviation score (H-SDS)
Months 6 and 12
Number of participants with adverse events
up to 24 months
Height velocity (HV)
Month 12
Study Arms (4)
TV-1106 0.554 mg
EXPERIMENTALTV-1106 0.924 mg/kg
EXPERIMENTALTV-1106 1.20 mg/kg
EXPERIMENTALsomatropin 0.033 mg/kg/day
ACTIVE COMPARATORDosages may be adjusted according to findings and as necessary
Interventions
TV-1106 0.554mg, TV-1106 0.924 mg, TV-1106 1.20 mg
Dose may be adjusted as required
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Teva Investigational Site 68016
Minsk, Belarus
Teva Investigational Site 59060
Varna, Bulgaria
Teva Investigational Site 81022
Tbilisi, Georgia
Teva Investigational Site 81023
Tbilisi, Georgia
Teva Investigational Site 81025
Tbilisi, Georgia
Teva Investigational Site 63046
Athens, Greece
Teva Investigational Site 51159
Budapest, Hungary
Teva Investigational Site 51160
Budapest, Hungary
Teva Investigational Site 51181
Szombathely, Hungary
Teva Investigational Site 80052
Afula, Israel
Teva Investigational Site 80055
Beersheba, Israel
Teva Investigational Site 80053
Petah Tikva, Israel
Teva Investigational Site 80056
Ramat Gan, Israel
Teva Investigational Site 53216
Warsaw, Poland
Teva Investigational Site 52056
Timișoara, Romania
Teva Investigational Site 50261
Izhevsk, Russia
Teva Investigational Site 50260
Kazan', Russia
Teva Investigational Site 50258
Moscow, Russia
Teva Investigational Site 50259
Moscow, Russia
Teva Investigational Site 50264
Novosibirsk, Russia
Teva Investigational Site 50267
Saint Petersburg, Russia
Teva Investigational Site 50268
Samara, Russia
Teva Investigational Site 50263
Saratov, Russia
Teva Investigational Site 50262
Tomsk, Russia
Teva Investigational Site 50265
Ufa, Russia
Teva Investigational Site 61030
Belgrade, Serbia
Teva Investigational Site 61032
Niš, Serbia
Teva Investigational Site 31099
Girona, Spain
Teva Investigational Site 82011
Ankara, Turkey (Türkiye)
Teva Investigational Site 82013
Aydin, Turkey (Türkiye)
Teva Investigational Site 58138
Kharkiv, Ukraine
Teva Investigational Site 58140
Kiev, Ukraine
Teva Investigational Site 58139
Kyiv, Ukraine
Teva Investigational Site 58142
Odesa, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director, MD
Teva Branded Pharmaceutical Products R&D, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2014
First Posted
March 19, 2014
Study Start
April 30, 2014
Primary Completion
April 30, 2016
Study Completion
August 31, 2016
Last Updated
November 9, 2021
Record last verified: 2021-11