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Study to Assess Safety and Tolerability in Adults With Growth Hormone-Deficiency (GHD)

Primary Purpose

Growth Hormone Deficiency

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TV-1106
dGH
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Growth Hormone Deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Teva Investigational Site 13137
  • Teva Investigational Site 13166
  • Teva Investigational Site 13165
  • Teva Investigational Site 13155
  • Teva Investigational Site 13158
  • Teva Investigational Site 13162
  • Teva Investigational Site 13136
  • Teva Investigational Site 13148
  • Teva Investigational Site 13138
  • Teva Investigational Site 13152
  • Teva Investigational Site 13161
  • Teva Investigational Site 13500
  • Teva Investigational Site 13503
  • Teva Investigational Site 13134
  • Teva Investigational Site 13129
  • Teva Investigational Site 13135
  • Teva Investigational Site 13146
  • Teva Investigational Site 13147
  • Teva Investigational Site 13143
  • Teva Investigational Site 13502
  • Teva Investigational Site 13140
  • Teva Investigational Site 13128
  • Teva Investigational Site 13142
  • Teva Investigational Site 13144
  • Teva Investigational Site 13163
  • Teva Investigational Site 13130
  • Teva Investigational Site 13141
  • Teva Investigational Site 13154
  • Teva Investigational Site 13159
  • Teva Investigational Site 13504
  • Teva Investigational Site 13164
  • Teva Investigational Site 13157
  • Teva Investigational Site 33035
  • Teva Investigational Site 54118
  • Teva Investigational Site 54119
  • Teva Investigational Site 54116
  • Teva Investigational Site 63059
  • Teva Investigational Site 63058
  • Teva Investigational Site 63060
  • Teva Investigational Site 51202
  • Teva Investigational Site 51206
  • Teva Investigational Site 51205
  • Teva Investigational Site 51204
  • Teva Investigational Site 51208
  • Teva Investigational Site 51207
  • Teva Investigational Site 30129
  • Teva Investigational Site 62041
  • Teva Investigational Site 31129
  • Teva Investigational Site 31121
  • Teva Investigational Site 31125

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TV-1106

dGH

Arm Description

TV-1106 to be injected once weekly.

dGH to be given as daily injections.

Outcomes

Primary Outcome Measures

Percentage of participants with adverse events
Safety of TV-1106 compared to reference drug

Secondary Outcome Measures

Change from baseline in Insulin-like Growth Factor 1 Standard Deviation Score

Full Information

First Posted
March 30, 2015
Last Updated
December 8, 2021
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02410356
Brief Title
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Business decision
Study Start Date
April 30, 2015 (Actual)
Primary Completion Date
February 29, 2016 (Actual)
Study Completion Date
April 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TV-1106
Arm Type
Experimental
Arm Description
TV-1106 to be injected once weekly.
Arm Title
dGH
Arm Type
Active Comparator
Arm Description
dGH to be given as daily injections.
Intervention Type
Drug
Intervention Name(s)
TV-1106
Other Intervention Name(s)
rhGH
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
dGH
Other Intervention Name(s)
rhGH, Somatropin
Intervention Description
The dose levels of dGH will be the same as the stable rhGH dose taken prior to the study.
Primary Outcome Measure Information:
Title
Percentage of participants with adverse events
Description
Safety of TV-1106 compared to reference drug
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in Insulin-like Growth Factor 1 Standard Deviation Score
Time Frame
Baseline, Weeks: 4, 8, 12, 16, 24, 36, 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teva Medical Expert, MD
Organizational Affiliation
Teva Branded Pharmaceutical Products R&D, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Teva Investigational Site 13137
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
Teva Investigational Site 13166
City
Fountain Valley
State/Province
California
ZIP/Postal Code
33155-6541
Country
United States
Facility Name
Teva Investigational Site 13165
City
Lakewood
State/Province
California
ZIP/Postal Code
90712
Country
United States
Facility Name
Teva Investigational Site 13155
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Teva Investigational Site 13158
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Teva Investigational Site 13162
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33312
Country
United States
Facility Name
Teva Investigational Site 13136
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
Teva Investigational Site 13148
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Teva Investigational Site 13138
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Teva Investigational Site 13152
City
Miami
State/Province
Florida
ZIP/Postal Code
33130
Country
United States
Facility Name
Teva Investigational Site 13161
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
Teva Investigational Site 13500
City
Miami
State/Province
Florida
ZIP/Postal Code
33155-6541
Country
United States
Facility Name
Teva Investigational Site 13503
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Teva Investigational Site 13134
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Teva Investigational Site 13129
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Teva Investigational Site 13135
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Teva Investigational Site 13146
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Teva Investigational Site 13147
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Teva Investigational Site 13143
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Teva Investigational Site 13502
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Teva Investigational Site 13140
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Teva Investigational Site 13128
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Teva Investigational Site 13142
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Teva Investigational Site 13144
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
Facility Name
Teva Investigational Site 13163
City
Dallas
State/Province
Texas
ZIP/Postal Code
75218
Country
United States
Facility Name
Teva Investigational Site 13130
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Teva Investigational Site 13141
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Teva Investigational Site 13154
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Teva Investigational Site 13159
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Teva Investigational Site 13504
City
Federal Way
State/Province
Washington
ZIP/Postal Code
98003
Country
United States
Facility Name
Teva Investigational Site 13164
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Teva Investigational Site 13157
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Teva Investigational Site 33035
City
Linz
ZIP/Postal Code
A-4020
Country
Austria
Facility Name
Teva Investigational Site 54118
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Teva Investigational Site 54119
City
Moravskoslezsky
ZIP/Postal Code
708 00
Country
Czechia
Facility Name
Teva Investigational Site 54116
City
Plzensky
ZIP/Postal Code
304 60
Country
Czechia
Facility Name
Teva Investigational Site 63059
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Teva Investigational Site 63058
City
Chaidari
ZIP/Postal Code
12462
Country
Greece
Facility Name
Teva Investigational Site 63060
City
Ioannina
Country
Greece
Facility Name
Teva Investigational Site 51202
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Teva Investigational Site 51206
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Teva Investigational Site 51205
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Teva Investigational Site 51204
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Teva Investigational Site 51208
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Teva Investigational Site 51207
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Teva Investigational Site 30129
City
Brescia
ZIP/Postal Code
25018
Country
Italy
Facility Name
Teva Investigational Site 62041
City
Lubochna
ZIP/Postal Code
034 91
Country
Slovakia
Facility Name
Teva Investigational Site 31129
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Teva Investigational Site 31121
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Teva Investigational Site 31125
City
Madrid
ZIP/Postal Code
28805
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Study to Assess Safety and Tolerability in Adults With Growth Hormone-Deficiency (GHD)

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