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

Growth Hormone Deficiency Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02410356
• Other study ID #: TV1106-IMM-30022
• Status: Terminated
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency

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