Clinical trial NCT02410356: Study to Assess Safety and Tolerability in Adults With Growth Hormone-Deficiency (GHD)
Official title: A Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (Genotropin(R)) in Adults With Growth Hormone-Deficiency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Growth Hormone Deficiency
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-07
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study assesses the safety and tolerability of weekly TV-1106 compared to daily rhGH in adults with GHD who have previously been treated with rhGH.


Eligibility criteria: Inclusion Criteria:

* males and females 18 years of age or over
* diagnosis of adult GHD for at least 6 months, or patients who have hypopituitarism from surgical resection
* treated with a stable dose of daily rhGH for at least 3 months prior to screening
* stable, adequate doses of replacement hormones (adrenal, thyroid, estrogen, testosterone, vasopressin) for at least 3 months prior to screening

  * Other criteria apply, please contact the investigator for more information

Exclusion Criteria:

* 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
* Presence of contraindications to rhGH treatment
* patients who have participated in another clinical trial with a new chemical/biological entity within 3 months of screening
* 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
* patients with a new diagnosis of pituitary adenoma or other intracranial tumor within 12 months of screening
* 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 year.
* patients with type 1 diabetes mellitus oror poorly controlled type 2 diabetes mellitus as indicated by a glycated hemoglobin (HbA1c) ≥8%
* patients using weight reducing agents or appetite suppressants

  * Other criteria apply, please contact the investigator for more information

Primary outcomes:
measure: Percentage of participants with adverse events
timeFrame: 48 weeks
Secondary outcomes:
measure: Change from baseline in Insulin-like Growth Factor 1 Standard Deviation Score
timeFrame: Baseline, Weeks: 4, 8, 12, 16, 24, 36, 48
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Teva Investigational Site 13137
state: California
city: Fountain Valley
country: United States
facility: Teva Investigational Site 13166
state: California
city: Lakewood
country: United States
facility: Teva Investigational Site 13165
state: California
city: Denver
country: United States
facility: Teva Investigational Site 13155
state: Colorado
city: Newark
country: United States
facility: Teva Investigational Site 13158
state: Delaware
city: Fort Lauderdale
country: United States
facility: Teva Investigational Site 13162
state: Florida
city: Homestead
country: United States
facility: Teva Investigational Site 13136
state: Florida
city: Miami Lakes
country: United States
facility: Teva Investigational Site 13148
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13138
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13152
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13161
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13500
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13503
state: Florida
city: Pembroke Pines
country: United States
facility: Teva Investigational Site 13134
state: Florida
city: West Palm Beach
country: United States
facility: Teva Investigational Site 13129
state: Florida
city: Detroit
country: United States
facility: Teva Investigational Site 13135
state: Michigan
city: Henderson
country: United States
facility: Teva Investigational Site 13146
state: Nevada
city: Las Vegas
country: United States
facility: Teva Investigational Site 13147
state: Nevada
city: Brooklyn
country: United States
facility: Teva Investigational Site 13143
state: New York
city: New York
country: United States
facility: Teva Investigational Site 13502
state: New York
city: New York
country: United States
facility: Teva Investigational Site 13140
state: New York
city: Asheville
country: United States
facility: Teva Investigational Site 13128
state: North Carolina
city: Pittsburgh
country: United States
facility: Teva Investigational Site 13142
state: Pennsylvania
city: Arlington
country: United States
facility: Teva Investigational Site 13144
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 13163
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 13130
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 13141
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 13154
state: Texas
city: Norfolk
country: United States
facility: Teva Investigational Site 13159
state: Virginia
city: Federal Way
country: United States
facility: Teva Investigational Site 13504
state: Washington
city: Seattle
country: United States
facility: Teva Investigational Site 13164
state: Washington
city: Tacoma
country: United States
facility: Teva Investigational Site 13157
state: Washington
city: Linz
country: Austria
facility: Teva Investigational Site 33035
city: Brno
country: Czechia
facility: Teva Investigational Site 54118
city: Moravskoslezsky
country: Czechia
facility: Teva Investigational Site 54119
city: Plzensky
country: Czechia
facility: Teva Investigational Site 54116
city: Athens
country: Greece
facility: Teva Investigational Site 63059
city: Chaidari
country: Greece
facility: Teva Investigational Site 63058
city: Ioannina
country: Greece
facility: Teva Investigational Site 63060
city: Budapest
country: Hungary
facility: Teva Investigational Site 51202
city: Budapest
country: Hungary
facility: Teva Investigational Site 51206
city: Debrecen
country: Hungary
facility: Teva Investigational Site 51205
city: Pecs
country: Hungary
facility: Teva Investigational Site 51204
city: Szeged
country: Hungary
facility: Teva Investigational Site 51208
city: Szolnok
country: Hungary
facility: Teva Investigational Site 51207
city: Brescia
country: Italy
facility: Teva Investigational Site 30129
city: Lubochna
country: Slovakia
facility: Teva Investigational Site 62041
city: Badalona
country: Spain
facility: Teva Investigational Site 31129
city: Cordoba
country: Spain
facility: Teva Investigational Site 31121
city: Madrid
country: Spain
facility: Teva Investigational Site 31125
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: