A Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (Genotropin(R)) in Adults With Growth Hormone-Deficiency

• Register: ClinicalTrials.gov
• Last refreshed on: 21 December 2021
• Main ID: NCT02410356
• Date of registration: 30/03/2015
• Prospective Registration: Yes
• Primary sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Public title: A Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (Genotropin(R)) in Adults With Growth Hormone-Deficiency
• Scientific title: A Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (Genotropin(R)) in Adults With Growth Hormone-Deficiency
• Date of first enrolment: April 30, 2015
• Target sample size: 34
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02410356
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Austria, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, Czechia, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Lithuania, Mexico, Peru, Poland, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Spain, Sweden, Turkey, Ukraine, United States

Contacts

• Name: Teva Medical Expert, MD
• Affiliation: Teva Branded Pharmaceutical Products R&D, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- males and females 18 years of age or over

- diagnosis of adult GHD for at least 6 months, or patients who have hypopituitarism
from surgical resection

- treated with a stable dose of daily rhGH for at least 3 months prior to screening

- stable, adequate doses of replacement hormones (adrenal, thyroid, estrogen,
testosterone, vasopressin) for at least 3 months prior to screening

- Other criteria apply, please contact the investigator for more information

Exclusion Criteria:

- patients with acute or chronic conditions or diseases that could confound results of
the study or put the patient at undue risk as determined by the investigator

- Presence of contraindications to rhGH treatment

- patients who have participated in another clinical trial with a new
chemical/biological entity within 3 months of screening

- patients with known active malignancy (excluding surgically removed basal cell
carcinoma or carcinoma in situ of cervix) d. patients with a previously treated
pituitary tumor with evidence of tumor progression in the past year

- patients with a new diagnosis of pituitary adenoma or other intracranial tumor within
12 months of screening

- presence of Prader-Willi syndrome, Turner's syndrome, untreated adrenal insufficiency,
active acromegaly in the past 5 years, or active Cushing's syndrome in the past year.

- patients with type 1 diabetes mellitus oror poorly controlled type 2 diabetes mellitus
as indicated by a glycated hemoglobin (HbA1c) =8%

- patients using weight reducing agents or appetite suppressants

- Other criteria apply, please contact the investigator for more information



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency

Intervention(s)

Drug: TV-1106

Drug: dGH

Primary Outcome(s)

Percentage of participants with adverse events [Time Frame: 48 weeks]

Secondary Outcome(s)

Change from baseline in Insulin-like Growth Factor 1 Standard Deviation Score [Time Frame: Baseline, Weeks: 4, 8, 12, 16, 24, 36, 48]

Secondary ID(s)

TV1106-IMM-30022

Source(s) of Monetary Support

Please refer to primary and secondary sponsors