Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the clinical effect of TV-1106.

Official Title
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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

Conditions
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Growth Hormone Deficiency

Intervention / Treatment
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* Drug: TV-1106
* Drug: Recombinant human growth hormone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 23 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: recombinant human growth hormone<br>Daily subcutaneous dose | Drug: Recombinant human growth hormone<br>* Subcutaneous once daily<br>|
| Experimental: TV-1106<br>Titration dose levels of TV-1106 | Drug: TV-1106<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin-like growth factor I (IGF-I) concentration change from baseline |  | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients treated with TV1106 who return to pre-treatment IGF-1 SDS |  | Baseline to Week 12 | 
| Safety Parameters | The safety of TV-1106 will be assessed throughout the study by evaluating adverse events,concomitant medication usage, physical examinations including urinalysis and body weight, vital sign measurements, clinical laboratory test results and hormone levels, electrocardiograms (ECGs), and immunogenicity. | 78 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Growth hormone deficiency, Insulin-like growth factor I (IGF-I), TV-1106