Clinical trial NCT01811576: Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Growth Hormone Deficiency
Keywords: Growth hormone deficiency
Insulin-like growth factor I (IGF-I)
TV-1106
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-14
Enrollment: 52
Sex: ALL
Minimum age (years): 23
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the clinical effect of TV-1106.


Eligibility 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.

Primary outcomes:
measure: Insulin-like growth factor I (IGF-I) concentration change from baseline
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Percentage of patients treated with TV1106 who return to pre-treatment IGF-1 SDS
timeFrame: Baseline to Week 12
measure: Safety Parameters
timeFrame: 78 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Teva Investigational Site 10564
state: Oregon
city: Hradec Kralove
country: Czechia
facility: Teva Investigational Site 54052
city: Olomouc
country: Czechia
facility: Teva Investigational Site 54051
city: Dresden
country: Germany
facility: Teva Investigational Site 32239
city: Munich
country: Germany
facility: Teva Investigational Site 32238
city: Munich
country: Germany
facility: Teva Investigational Site 32237
city: Athens
country: Greece
facility: Teva Investigational Site 63044
city: Athens
country: Greece
facility: Teva Investigational Site 63045
city: Budapest
country: Hungary
facility: Teva Investigational Site 51056
city: Budapest
country: Hungary
facility: Teva Investigational Site 51055
city: Debrecen
country: Hungary
facility: Teva Investigational Site 51060
city: Gyor
country: Hungary
facility: Teva Investigational Site 51061
city: Pecs
country: Hungary
facility: Teva Investigational Site 51059
city: Szeged
country: Hungary
facility: Teva Investigational Site 51057
city: Szolnok
country: Hungary
facility: Teva Investigational Site 51058
city: Jerusalem
country: Israel
facility: Teva Investigational Site 80033
city: Petach Tikva
country: Israel
facility: Teva Investigational Site 80032
city: Tel Aviv
country: Israel
facility: Teva Investigational Site 80034
city: Belgrade
country: Serbia
facility: Teva Investigational Site 61029
city: Bratislava
country: Slovakia
facility: Teva Investigational Site 62017
city: Bratislava
country: Slovakia
facility: Teva Investigational Site 62022
city: Lubochna
country: Slovakia
facility: Teva Investigational Site 62016
city: Ljubljana
country: Slovenia
facility: Teva Investigational Site 64016
Study officials:
References: