Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency

Growth Hormone Deficiency Clinical Trial

Official title:

A 64-Week (12-week Core Phase and 52-week Safety Extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01811576
• Other study ID #: TV1106-GHD-201
• Secondary ID: 2012-004975-37
• Status: Completed
• Phase: Phase 2
• Start date: March 31, 2013
• Est. completion date: August 5, 2013

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

The primary objective of this study is to evaluate the clinical effect of TV-1106.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 5, 2013
• Est. primary completion date: August 5, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patient agrees to provide written informed consent and to comply with the study protocol after reading the informed consent and discussing the study with the investigator.
• Males and females between 23 and 65 years of age must have a confirmed diagnosis of adult GHD, either adult onset (AO) GHD due to hypothalamic-pituitary disease or childhood onset (CO) GHD that is either idiopathic or due to hypothalamic-pituitary disease or due to genetic causes.
• Diagnosis of GH deficiency must be confirmed by documented (medical records) diagnostic testing.
• Patients should have been treated with a stable dose of daily rhGH for at least 3 months prior to screening.
• Other criteria apply.

Exclusion Criteria:

• Patients with history or clinical evidence of active or chronic diseases that could confound results of the study or put the subject at undue risk as determined by the investigator.
• Patients with known active malignancy
• Patients with history of malignancy other than intracranial tumor causing GHD (excluding surgically cured basal cell or squamous cell cancer of the skin with documented 6 month remission)
• Patients with evidence of pituitary adenoma or other intracranial tumor within 12 months of enrollment, which is on day 0 (baseline, Visit 3)
• Patients without magnetic resonance imaging (MRI) or computerized tomography (CT) data to document tumor stability within the 12 months prior to enrollment, which is on day 0 (baseline, Visit 3)
• 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.
• Other criteria apply.

Related Conditions & MeSH terms

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

Intervention

Drug:
• TV-1106

• Recombinant human growth hormone
Subcutaneous once daily

Locations

Country	Name	City	State
Czechia	Teva Investigational Site 54052	Hradec Kralove
Czechia	Teva Investigational Site 54051	Olomouc
Germany	Teva Investigational Site 32239	Dresden
Germany	Teva Investigational Site 32237	Munich
Germany	Teva Investigational Site 32238	Munich
Greece	Teva Investigational Site 63044	Athens
Greece	Teva Investigational Site 63045	Athens
Hungary	Teva Investigational Site 51055	Budapest
Hungary	Teva Investigational Site 51056	Budapest
Hungary	Teva Investigational Site 51060	Debrecen
Hungary	Teva Investigational Site 51061	Gyor
Hungary	Teva Investigational Site 51059	Pecs
Hungary	Teva Investigational Site 51057	Szeged
Hungary	Teva Investigational Site 51058	Szolnok
Israel	Teva Investigational Site 80033	Jerusalem
Israel	Teva Investigational Site 80032	Petach Tikva
Israel	Teva Investigational Site 80034	Tel Aviv
Serbia	Teva Investigational Site 61029	Belgrade
Slovakia	Teva Investigational Site 62017	Bratislava
Slovakia	Teva Investigational Site 62022	Bratislava
Slovakia	Teva Investigational Site 62016	Lubochna
Slovenia	Teva Investigational Site 64016	Ljubljana
United States	Teva Investigational Site 10564	Portland	Oregon

Sponsors (1)

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

Countries where clinical trial is conducted

United States,  Czechia,  Germany,  Greece,  Hungary,  Israel,  Serbia,  Slovakia,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin-like growth factor I (IGF-I) concentration change from baseline		Baseline to Week 12
Secondary	Percentage of patients treated with TV1106 who return to pre-treatment IGF-1 SDS		Baseline to Week 12
Secondary	Safety Parameters	The safety of TV-1106 will be assessed throughout the study by evaluating adverse events,concomitant medication usage, physical examinations including urinalysis and body weight, vital sign measurements, clinical laboratory test results and hormone levels, electrocardiograms (ECGs), and immunogenicity.	78 weeks