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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02410356
Other study ID # TV1106-IMM-30022
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date April 30, 2015
Est. completion date April 30, 2016

Study information

Verified date December 2021
Source Teva Branded Pharmaceutical Products R&D, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 34
Est. completion date April 30, 2016
Est. primary completion date February 29, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
TV-1106
The volume necessary to provide the required weekly dose will be calculated by the investigator; dose will be adjusted for IGF-I in the normal range.
dGH
The dose levels of dGH will be the same as the stable rhGH dose taken prior to the study.

Locations

Country Name City State
Austria Teva Investigational Site 33035 Linz
Czechia Teva Investigational Site 54118 Brno
Czechia Teva Investigational Site 54119 Moravskoslezsky
Czechia Teva Investigational Site 54116 Plzensky
Greece Teva Investigational Site 63059 Athens
Greece Teva Investigational Site 63058 Chaidari
Greece Teva Investigational Site 63060 Ioannina
Hungary Teva Investigational Site 51202 Budapest
Hungary Teva Investigational Site 51206 Budapest
Hungary Teva Investigational Site 51205 Debrecen
Hungary Teva Investigational Site 51204 Pecs
Hungary Teva Investigational Site 51208 Szeged
Hungary Teva Investigational Site 51207 Szolnok
Italy Teva Investigational Site 30129 Brescia
Slovakia Teva Investigational Site 62041 Lubochna
Spain Teva Investigational Site 31129 Badalona
Spain Teva Investigational Site 31121 Cordoba
Spain Teva Investigational Site 31125 Madrid
United States Teva Investigational Site 13144 Arlington Texas
United States Teva Investigational Site 13137 Artesia California
United States Teva Investigational Site 13128 Asheville North Carolina
United States Teva Investigational Site 13143 Brooklyn New York
United States Teva Investigational Site 13163 Dallas Texas
United States Teva Investigational Site 13155 Denver Colorado
United States Teva Investigational Site 13135 Detroit Michigan
United States Teva Investigational Site 13504 Federal Way Washington
United States Teva Investigational Site 13162 Fort Lauderdale Florida
United States Teva Investigational Site 13166 Fountain Valley California
United States Teva Investigational Site 13146 Henderson Nevada
United States Teva Investigational Site 13136 Homestead Florida
United States Teva Investigational Site 13130 Houston Texas
United States Teva Investigational Site 13141 Houston Texas
United States Teva Investigational Site 13154 Houston Texas
United States Teva Investigational Site 13165 Lakewood California
United States Teva Investigational Site 13147 Las Vegas Nevada
United States Teva Investigational Site 13138 Miami Florida
United States Teva Investigational Site 13152 Miami Florida
United States Teva Investigational Site 13161 Miami Florida
United States Teva Investigational Site 13500 Miami Florida
United States Teva Investigational Site 13503 Miami Florida
United States Teva Investigational Site 13148 Miami Lakes Florida
United States Teva Investigational Site 13140 New York New York
United States Teva Investigational Site 13502 New York New York
United States Teva Investigational Site 13158 Newark Delaware
United States Teva Investigational Site 13159 Norfolk Virginia
United States Teva Investigational Site 13134 Pembroke Pines Florida
United States Teva Investigational Site 13142 Pittsburgh Pennsylvania
United States Teva Investigational Site 13164 Seattle Washington
United States Teva Investigational Site 13157 Tacoma Washington
United States Teva Investigational Site 13129 West Palm Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Countries where clinical trial is conducted

United States,  Austria,  Czechia,  Greece,  Hungary,  Italy,  Slovakia,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of participants with adverse events Safety of TV-1106 compared to reference drug 48 weeks
Secondary Change from baseline in Insulin-like Growth Factor 1 Standard Deviation Score Baseline, Weeks: 4, 8, 12, 16, 24, 36, 48
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