Brief Title
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
Brief Summary
The purpose of this study is to support selection of an appropriate safe and efficacious dose
for study in further development.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Height velocity (HV)
Secondary Outcome
Height velocity standard deviation score (HV-SDS)
Condition
Growth Hormone-Deficiency
Intervention
TV-1106
Study Arms / Comparison Groups
TV-1106 0.554 mg
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
65
Start Date
April 30, 2014
Completion Date
August 31, 2016
Primary Completion Date
April 30, 2016
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
Gender
All
Ages
3 Years - 11 Years
Accepts Healthy Volunteers
No
Contacts
Medical Director, MD, ,
Location Countries
Belarus
Location Countries
Belarus
Administrative Informations
NCT ID
NCT02092077
Organization ID
TV1106-IMM-20001
Secondary IDs
2013-004468-69
Responsible Party
Sponsor
Study Sponsor
Teva Pharmaceutical Industries, Ltd.
Study Sponsor
Medical Director, MD, Study Director, Teva Branded Pharmaceutical Products R&D, Inc.
Verification Date
November 2021