A 64-Week (12-week Core Phase and 52-week Safety Extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency

• Register: ClinicalTrials.gov
• Last refreshed on: 21 December 2021
• Main ID: NCT01811576
• Date of registration: 12/03/2013
• Prospective Registration: Yes
• Primary sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Public title: A 64-Week (12-week Core Phase and 52-week Safety Extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency
• Scientific title: A 64-Week (12-week Core Phase and 52-week Safety Extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency
• Date of first enrolment: March 31, 2013
• Target sample size: 52
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01811576
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Czech Republic, Czechia, Germany, Greece, Hungary, Israel, Serbia, Slovakia, Slovenia, Sweden, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patient agrees to provide written informed consent and to comply with the study
protocol after reading the informed consent and discussing the study with the
investigator.

- Males and females between 23 and 65 years of age must have a confirmed diagnosis of
adult GHD, either adult onset (AO) GHD due to hypothalamic-pituitary disease or
childhood onset (CO) GHD that is either idiopathic or due to hypothalamic-pituitary
disease or due to genetic causes.

- Diagnosis of GH deficiency must be confirmed by documented (medical records)
diagnostic testing.

- Patients should have been treated with a stable dose of daily rhGH for at least 3
months prior to screening.

- Other criteria apply.

Exclusion Criteria:

- Patients with history or clinical evidence of active or chronic diseases that could
confound results of the study or put the subject at undue risk as determined by the
investigator.

- Patients with known active malignancy

- Patients with history of malignancy other than intracranial tumor causing GHD
(excluding surgically cured basal cell or squamous cell cancer of the skin with
documented 6 month remission)

- Patients with evidence of pituitary adenoma or other intracranial tumor within 12
months of enrollment, which is on day 0 (baseline, Visit 3)

- Patients without magnetic resonance imaging (MRI) or computerized tomography (CT) data
to document tumor stability within the 12 months prior to enrollment, which is on day
0 (baseline, Visit 3)

- 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 1
year.

- Other criteria apply.



Age minimum: 23 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency

Intervention(s)

Drug: Recombinant human growth hormone

Drug: TV-1106

Primary Outcome(s)

Insulin-like growth factor I (IGF-I) concentration change from baseline [Time Frame: Baseline to Week 12]

Secondary Outcome(s)

Safety Parameters [Time Frame: 78 weeks]

Percentage of patients treated with TV1106 who return to pre-treatment IGF-1 SDS [Time Frame: Baseline to Week 12]

Secondary ID(s)

TV1106-GHD-201

2012-004975-37

Source(s) of Monetary Support

Please refer to primary and secondary sponsors