Clinical trial NCT02410343: Study of TV-1106 in Growth Hormone-Deficient Adults
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy, Safety and Tolerability Study of TV-1106 in Growth Hormone-Deficient Adults Who Are Not Current Users of rhGH Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Growth Hormone Deficiency
Keywords: long acting growth hormone
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-07
Enrollment: 14
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: 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.


Eligibility criteria: Inclusion:

* males and females 18 years of age or over
* diagnosis of adult growth hormone deficiency (GHD) for at least 6 months, or patients who have hypopituitarism from surgical resection
* no history of exposure to any rhGH within the past 12 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:

* 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)
* 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 1 year
* patients with type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus as indicated by a glycated hemoglobin (HBA1c) of ≥8%
* patients using weight reducing agents or appetite suppressants
* women who are pregnant or nursing, or planning pregnancy during the study period

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

Primary outcomes:
measure: Body Fat Mass at Baseline, Week 24 and Endpoint in Core Period
timeFrame: Baseline (Day 1, pre-dose), Week 24, Endpoint in Core period
Secondary outcomes:
measure: Total Trunk Fat at Baseline, Week 24 and Endpoint in Core Period
timeFrame: Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period
measure: Insulin-Like Growth Factor 1 Standard Deviation Score (IGF-I SDS) at Baseline, Week 24 and Endpoint in Core Period
timeFrame: Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period
measure: Scored Analysis of Quality of Life Assessment of GH Deficiency in Adults (QoL-AGHDA) at Baseline, Week 24 and Endpoint in Core Period
timeFrame: Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period
measure: Participants With Adverse Events During the Core Period
timeFrame: Day 1 up to 24 Weeks
measure: Participants With Potentially Clinically Significant Abnormal Blood and Urine Test Results
timeFrame: Day 1 up to 24 Weeks
measure: Shift From Baseline To Endpoint in Core Period in Electrocardiogram Findings
timeFrame: Day 1 up to Week 24
measure: Thyroid Stimulating Hormone (TSH) at Baseline and Endpoint
timeFrame: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
measure: Free Thyroxin (Free T4) at Baseline and Endpoint
timeFrame: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
measure: Triiodothyronine (Total T3) at Baseline and Endpoint
timeFrame: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
measure: Glycated Hemoglobin (HbA1c) at Baseline and Endpoint
timeFrame: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
measure: Fasting Blood Glucose at Baseline and Endpoint
timeFrame: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
measure: Insulin at Baseline and Endpoint
timeFrame: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
measure: Local Tolerability Assessed by Injection Site Reactions
timeFrame: Daay 1 up to Week 24
measure: Pharmacokinetic Serum Concentration of TV1106 by Nominal Sampling Timepoints
timeFrame: Baseline (Day 1, pre-dose), Weeks 4, 8, 12, 16, 24
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Teva Investigational Site 13102
state: California
city: Fountain Valley
country: United States
facility: Teva Investigational Site 13127
state: California
city: Fountain Valley
country: United States
facility: Teva Investigational Site 13126
state: California
city: Miami Lakes
country: United States
facility: Teva Investigational Site 13114
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13103
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13118
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13123
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 13492
state: Florida
city: Pembroke Pines
country: United States
facility: Teva Investigational Site 13100
state: Florida
city: West Palm Beach
country: United States
facility: Teva Investigational Site 13121
state: Florida
city: Chicago
country: United States
facility: Teva Investigational Site 13104
state: Illinois
city: Evansville
country: United States
facility: Teva Investigational Site 13124
state: Indiana
city: Detroit
country: United States
facility: Teva Investigational Site 13101
state: Michigan
city: Henderson
country: United States
facility: Teva Investigational Site 13112
state: Nevada
city: Las Vegas
country: United States
facility: Teva Investigational Site 13113
state: Nevada
city: Brooklyn
country: United States
facility: Teva Investigational Site 13109
state: New York
city: New York
country: United States
facility: Teva Investigational Site 13494
state: New York
city: New York
country: United States
facility: Teva Investigational Site 13106
state: New York
city: Asheville
country: United States
facility: Teva Investigational Site 13096
state: North Carolina
city: Pittsburgh
country: United States
facility: Teva Investigational Site 13108
state: Pennsylvania
city: Arlington
country: United States
facility: Teva Investigational Site 13110
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 13125
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 13097
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 13107
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 13120
state: Texas
city: Linz
country: Austria
facility: Teva Investigational Site 33030
city: Moravskoslezsky
country: Czechia
facility: Teva Investigational Site 54112
city: Athens
country: Greece
facility: Teva Investigational Site 63054
city: Chaidari
country: Greece
facility: Teva Investigational Site 63053
city: Budapest
country: Hungary
facility: Teva Investigational Site 51197
city: Pecs
country: Hungary
facility: Teva Investigational Site 51195
city: Brescia
country: Italy
facility: Teva Investigational Site 30112
city: Saint-Petersburg
country: Russian Federation
facility: Teva Investigational Site 50303
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: