Growth hormone deficiency MedDRA version: 17.1 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Product Name: Albutropin
Product Code: TV-1106
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Albutropin
Current Sponsor code: TV-1106
Other descriptive name: Human Serum
Sponsors
Teva Pharmaceutical Industries Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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 a new diagnosis of pituitary adenoma or other intracranial tumor within 12 months of baseline (Visit 3) 5.) 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. 6.) Patients with known history of severe allergic or anaphylactic reactions 7.) Patients with known allergy or hypersensitivity to rhGH, HSA, yeastderived products, or any other component of the formulation 8.) Patients with antibodies to hGH following the washout period. 9.) 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. 10.) 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 11.) 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. 12.) Patients who have participated in another clinical trial with a new chemical/biological entity within 3 months of screening 13.) Patients who have clinically significant abnormal electrocardiogram (ECG) as determined by the investigator 14.) Patients with untreated or poorly controlledhypertension, and patients with Stage 2 hypertension (SBP>=160mmHg and/or DBP>=100(as defined in JNC, 2004)). 15.) 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. 16.) Patients with known history of or confirmed positive test results for human immunodeficiency virus (HIV) types 1 and 2 at screening 17.) Patients with known Hepatitis B or Hepatitis C infection. 18.) Patients using weight reducing agents or appetite suppressants. 19.) Patients with persistent or recurring migraines, clinically important edema carpal tunnel syndrome, paresthesias, or other nerve compression symptoms as assessed by the investigator. 20.) Patients with known diagnosis of diabetes or pre-deabetes (impaired fasting glucose) as defined in the American Diabetes Association position statement (ADA, 2013)21.) Women who are pregnant or nursing at the time of screening or who intend to be during the study period. 22.) 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. skin creams, eyedrops). Inhaled budesonide will be permitted at a monthly consumption not to exceed 400 µg/day for 3 days (total 1200 µg/month). 23.) Patients with a malignant appearing skin lesion un
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the clinical effect of weekly doses of TV-1106, as measured by the change from baseline in IGF-I, in GHD adults following 12 weeks of treatment.;Secondary Objective: ? To assess the extent of the adult GHD patient population that responds positively to weekly TV-1106 as demonstrated by an increase in IGF-I standard deviation score (SDS) ? To determine the effect of long-term TV-1106 treatment on maintenance of or improvement in the lipid profile of adult GHD patients treated with TV-1106 for 64 weeks;Primary end point(s): The primary efficacy variable for this study is IGF-I concentration (ng/ml). The primary endpoint is the change from baseline in IGF-I SDS to Cmax level during week 12, for patients treated with TV-1106.;Timepoint(s) of evaluation of this end point: during week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy variables and endpoints for this study are as follows: 1. The percentage of patients, treated with TV-1106, who return by the trough level of IGF-I SDS during study week 12 to their pre-washout (screening) IGF-I SDS level (± 0.5 SDS) and their Cmax level during week 12 is below +2.0 SDS. ;Timepoint(s) of evaluation of this end point: 1.The percentage of patients, treated with TV-1106, who return by the trough level of IGF-I SDS during study week 12 to their pre-washout (screening) IGF-I SDS level (± 0.5 SDS) and their Cmax level during week 12 is below +2.0 SDS. | — |
Countries
Czech Republic, Denmark, France, Germany, Greece, Hungary, Israel, Serbia, Slovakia, Slovenia, Sweden, United States
Contacts
Public ContactClinical trial information desk
Teva Pharma GmbH
Outcome results
None listed