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

Phase 2

Completed

• Conditions: Growth Hormone Deficiency
• Interventions: Drug: Recombinant human growth hormone; Drug: TV-1106

• Registration Number: NCT01811576
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-12
• Study First Submitted QC: 2013-03-12
• Study First Posted: 2013-03-14
• Study Start: 2013-03-31
• Primary Completion: 2013-08-05
• Study Completion: 2013-08-05
• Disposition First Submitted: 2018-05-21
• Disposition First Submitted QC: 2018-05-21
• Disposition First Posted: 2018-05-23
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-08
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
recombinant human growth hormone	Recombinant human growth hormone	Daily subcutaneous dose
TV-1106	TV-1106	Titration dose levels of TV-1106

Primary Outcome Measures

Name	Time	Method
Insulin-like growth factor I (IGF-I) concentration change from baseline	Baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
Safety Parameters	78 weeks	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.
Percentage of patients treated with TV1106 who return to pre-treatment IGF-1 SDS	Baseline to Week 12

Trial Locations

Locations (23)

Teva Investigational Site 63044; 🇬🇷 Athens, Greece

Teva Investigational Site 62022; 🇸🇰 Bratislava, Slovakia

Teva Investigational Site 64016; 🇸🇮 Ljubljana, Slovenia

Teva Investigational Site 51059; 🇭🇺 Pecs, Hungary

Teva Investigational Site 10564; 🇺🇸 Portland, Oregon, United States

Teva Investigational Site 62016; 🇸🇰 Lubochna, Slovakia

Teva Investigational Site 51060; 🇭🇺 Debrecen, Hungary

Teva Investigational Site 54052; 🇨🇿 Hradec Kralove, Czechia

Teva Investigational Site 61029; 🇷🇸 Belgrade, Serbia

Teva Investigational Site 32237; 🇩🇪 Munich, Germany

Teva Investigational Site 51055; 🇭🇺 Budapest, Hungary

Teva Investigational Site 54051; 🇨🇿 Olomouc, Czechia

Teva Investigational Site 80033; 🇮🇱 Jerusalem, Israel

Teva Investigational Site 32238; 🇩🇪 Munich, Germany

Teva Investigational Site 63045; 🇬🇷 Athens, Greece

Teva Investigational Site 32239; 🇩🇪 Dresden, Germany

Teva Investigational Site 51056; 🇭🇺 Budapest, Hungary

Teva Investigational Site 51061; 🇭🇺 Gyor, Hungary

Teva Investigational Site 51057; 🇭🇺 Szeged, Hungary

Teva Investigational Site 80032; 🇮🇱 Petach Tikva, Israel

Teva Investigational Site 62017; 🇸🇰 Bratislava, Slovakia

Teva Investigational Site 80034; 🇮🇱 Tel Aviv, Israel

Teva Investigational Site 51058; 🇭🇺 Szolnok, Hungary