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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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15 November 2021 |
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Main ID: |
NCT02092077 |
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Date of registration:
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14/03/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children
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Scientific title:
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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 |
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Date of first enrolment:
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April 30, 2014 |
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Target sample size:
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65 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02092077 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Belarus
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Bulgaria
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Czech Republic
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Georgia
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Greece
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Hungary
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Israel
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Poland
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Romania
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Russian Federation
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Serbia
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Slovenia
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Spain
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Turkey
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Ukraine
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Contacts
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Name:
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Medical Director, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Teva Branded Pharmaceutical Products R&D, Inc. |
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Key inclusion & exclusion criteria
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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
Age minimum:
3 Years
Age maximum:
11 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Growth Hormone-Deficiency
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Intervention(s)
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Drug: somatropin
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Drug: TV-1106
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Primary Outcome(s)
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Height velocity (HV)
[Time Frame: Month 6]
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Secondary Outcome(s)
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Number of participants with adverse events
[Time Frame: up to 24 months]
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Height standard deviation score (H-SDS)
[Time Frame: Months 6 and 12]
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Height velocity (HV)
[Time Frame: Month 12]
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Height velocity standard deviation score (HV-SDS)
[Time Frame: Months 6 and 12]
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Secondary ID(s)
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2013-004468-69
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TV1106-IMM-20001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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