Growth hormone deficiency MedDRA version: 17.1 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Albutropin
Other descriptive name: RECOMBINANT HUMAN SERUM ALBUMIN (HSA) FUSED TO HUMAN GROWTH HORMONE (HGH)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration n
Sponsors
Teva Pharmaceutical Industries Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients may be included in the study if they meet all of the following criteria: a. provision of written informed consent and agreement to comply with study requirements b. males and females 18 years of age or over c. body mass index (BMI) between 19 and 35 kg/m2 inclusive d. diagnosis of adult GHD for at least 6 months, confirmed by medical record diagnostic testing specified by an accepted guidance (eg, Carroll 1998; Cook 2009; Ho 2007; Molitch 2011) in effect at the time of diagnosis or patients who have hypopituitarism from surgical resection e. no history of exposure to any rhGH within the past 12 months prior to screening f. IGF-I SDS level less than -1.0 at screening g. stable, adequate doses of replacement hormones (adrenal, thyroid, estrogen, testosterone, vasopressin) for at least 3 months prior to screening as clinically judged by the investigator to be adequate h. patients not receiving glucocorticoid replacement therapy must have adequate adrenal function confirmed by adrenocorticotropic hormone (ACTH) stimulation test at screening i. women of child-bearing potential must be willing to use a medically accepted method of contraception for the duration of the study and for 30 days after participation in the study (acceptable methods of contraception include: double barrier method [condom or diaphragm with spermicide], intrauterine device [IUD], partner’s vasectomy, or steroidal contraceptive [oral, transdermal, implanted, injected]). Patients who are gonadotropin deficient, surgically sterile, or at least 1 year post-menopausal are not required to use contraception. 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 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from participating in this study if they meet 1 or more of the following criteria: a. 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 b. patients who have participated in another clinical trial with a new chemical/biological entity within 3 months of screening c. 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 (evidence will be established by magnetic resonance imaging [MRI] or computerized tomography [CT] obtained within 3 months of screening or at screening. Patients will be excluded if they show any progression from a prior scan taken at least 12 months prior to the current scan.) e. patients with a new diagnosis of pituitary adenoma or other intracranial tumor within 12 months of screening f. 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 g. patients with known allergy or hypersensitivity to rhGH, HSA, yeast-derived products, or any other component of the formulation h. patients who are unable to undergo scanning by dual-energy x-ray absorptiometry (DXA) (eg, due to excessive body weight or implanted devices which would interfere with DXA) i. patients with previous signs or history of increased intracranial pressure (ICP) with rhGH treatment, or documented ICP or signs of ICP on fundoscopic examination at the time of screening (may be performed by investigator or referred to an ophthalmologist) Patients with previous history of ICP due to treated tumors that have resolved can be included in the study. j. patients with severe, clinically significant, persistent or recurring migraines, edema, or history or presence of carpal tunnel syndrome, or other nerve compression symptoms assessed as clinically important by the investigator k. patients with untreated or poorly controlled stage 2 hypertension (systolic blood pressure [SBP] =150 mmHg and/or diastolic blood pressure [DBP] =90 mmHg) l. patients with clinically significant abnormalities on the screening laboratory assessments, electrocardiogram (ECG), or physical examination that would confound the interpretation of the study or put the patient at undue risk of participation in the study as determined by the investigator. m. patients with type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus as indicated by a glycated hemoglobin (HBA1c) of =8% n. patients who use anabolic steroids or corticosteroids except for physiological maintenance doses used as treatment for patients with hormone deficiencies. limited use of low dose glucocorticoid preparations is allowed (eg, topical preparations); inhaled budesonide will be permitted at a dose not to exceed 400 µg/day for 3 days (total <1200 µg/month) or equivalent. o. patients using weight reducing agents or appetite suppressants p. women who are pregnant or nursing, or planning pregnancy during the study period q. patients with active or known history of substance abuse that in the investigator’s opinion would affect compliance with the study r. patients with known tendency to have injection site lipoatrophy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Efficacy Variables and Endpoints: The primary endpoint is the change from baseline to week 24 in body fat mass (kg) as measured by DXA. ;Timepoint(s) of evaluation of this end point: Week 24;Main Objective: The primary objective of this study is to determine the efficacy of 6 months of treatment with TV-1106 compared with placebo on body fat composition.;Secondary Objective: The secondary objectives of the study are to assess additional body composition measures, insulin-like growth factor 1 standard deviation score (IGF-I SDS), quality of life (QOL), the safety, and tolerability of treatment, pharmacokinetics, pharmacokinetic/pharmacodynamic analysis, and pharmacogenomics (PGx) with TV-1106. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy Variables and Endpoints: The secondary efficacy variables and endpoints for this study are as follows: - change from baseline to week 24 in total trunk fat (kg) as measured by DXA - change in IGF-I SDS from baseline to week 24 - change in QOL scores from baseline to week 24 by questionnaire (assessment of GHD in adults [AGHDA]) Other Efficacy Variables and Endpoints: - change from baseline to week 24 in lean body mass (DXA), percentage body fat (DXA), percentage trunk fat (DXA), and percentage change in trunk fat (DXA) - proportion of patients with IGF-I SDS within the normal range (-0.5 to +1.5) at week 24 The following endpoints will be analyzed for all patients, and although all patients will receive TV-1106 during the 12-month extension phase, data will be analyzed by the original treatment assignment: - change from baseline to weeks 24, 48, and 72 in total trunk fat (DXA), lean body mass (DXA), percentage body fat (DXA), percentage trunk fat (DXA), and percentage change in trunk fat from week 24 through 72 - change in IGF-I from baseline to week 24, week 48, and week 72 (IGF-I SDS) - change in lipids between baseline to week 24 and week 72 (as measured by total cholesterol, low-density lipoprotein [LDL] cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides, and lipoprotein) - change from baseline to week 48in QOL as measured by questionnaire (AGHDA) scores Exploratory Efficacy Variables and Endpoints: - change from baseline in QOL as measured by questionnaire (EQ5D-5L) scores and injection satisfaction questionnaire at all other time points Safety Variables and Endpoints: Safety variables and endpoints will include the following: - adverse event reports throughout the study - clinical laboratory test results - vital sign measurements - ECG findings and physical examination findings - concomitant medication usage throughout the study - changes in replacement hormones (thyroid stimulating | — |
Countries
Argentina, Austria, Belarus, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Lithuania, Mexico, Peru, Poland, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Spain, Sweden, Turkey, Ukraine, United States
Contacts
Public ContactClinical Trial Information Desk
Teva Pharma GmbH
Outcome results
None listed