A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug).

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

1.) 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.
2.) 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.
3.) Diagnosis of GH deficiency must be confirmed by documented (medical records) diagnostic testing specified by an accepted guidance (e.g., GH Research Society Consensus guidelines for the diagnosis and treatment of adults with GH deficiency 2007; AACE Clinical Practice Guidelines 2009; Endocrine Society Clinical Practice Guidelines Molitch et.al. 2006 and 2011) in effect at the time of
diagnosis.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.)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.
2.) Patients with known active malignancy
3.) 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)
4.) Patients with evidence of pituitary adenoma or other intracranial tumor within 12 months of enrollment, which is on day 0 (baseline, Visit 3)
5.) 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) (NOTE: please see Restrictions – Medical History, Section 5.2)
6.) 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.
7.) Patients with known history of severe allergic or anaphylactic reactions
8.) Patients with known allergy or hypersensitivity to rhGH, HSA, yeast-derived products, or any other component of the formulation
9.) Patients with antibodies to hGH following the washout period.
10.) Patients who will require a dose of the study drug (TV-1106) in excess of 50 mg/week or of Genotropin® in excess of 1.8 mg/day at baseline visit.
11.) Patients who have had 1 of the following conditions in the noted amount of time prior to screening or between screening and first dosing day: major trauma or surgery within 6 months; acute infection requiring systemic antibiotic treatment within 4 weeks; any acute, severe illness within 6 months
12.) Patients with history of documented increased intracranial pressure (ICP) associated with GH treatment or signs of increased ICP including papilledema based on fundoscopic exam performed by investigator or ophthalmologist during screening.
13.) Patients who have participated in another clinical trial with a new
chemical/biological entity within 3 months of screening
14.) Patients who have clinically significant abnormal electrocardiogram (ECG) as determined by the investigator
15.) Patients with blood pressure (treated) outside the ranges 90 to 139 or mHg systolic or 45 to 89 mmHg diastolic, inclusive.
16.) Patients with abnormal levels [greater than x2 the upper limit of normal (ULN)] of alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (GGT) or total bilirubin at screening or baseline
17.) Patients with known history of or confirmed positive test results for human immunodeficiency virus (HIV) types 1 and 2 at screening
18.) Patients with known history of or a positive test result for hepatitis B (HBsAg) or hepatitis C virus (HCV) at screening
19.) Patients using weight reducing agents or appetite suppressants.
20.) Patients with persistent or recurring migraines, edema, arthralgias (not due to osteoarthritis), myalgias, carpal tunnel syndrome, paresthesias, or other nerve compression symptoms.
21.) Patients with diagnosis of diabetes mellitus or patients with impaired fasting blood glucose (100 – 125 mg/dL, inclusive).
22.) Women who are pregnant or nursing at the time of screening or who intend to be during the study period.
23.) Patients who use anabolic steroids or corticosteroids except for physiological maintenance doses used as treatment for patients with hormone deficiencies. Limited use

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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