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

NCT01811576 | Completed Phase 2 DMC

• 2 other identifiers: TV1106-GHD-2012012-004975-37
• Study Type: interventional
• Target: 52
• Locations: 8 countries
• Sites: 22

Brief Summary

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

Conditions

Growth Hormone Deficiency

Keywords

Growth hormone deficiency; Insulin-like growth factor I (IGF-I); TV-1106

Outcome Measures

Primary Outcomes (1)

• Insulin-like growth factor I (IGF-I) concentration change from baseline

  Baseline to Week 12

Secondary Outcomes (2)

• Percentage of patients treated with TV1106 who return to pre-treatment IGF-1 SDS

  Baseline to Week 12

• Safety Parameters

  78 weeks

Study Arms (2)

recombinant human growth hormone

ACTIVE COMPARATOR

Daily subcutaneous dose

Drug: Recombinant human growth hormone

TV-1106

EXPERIMENTAL

Titration dose levels of TV-1106

Drug: TV-1106

Interventions

TV-1106 DRUG

TV-1106

Recombinant human growth hormone DRUG

Subcutaneous once daily

recombinant human growth hormone

Eligibility Criteria

• Age: 23 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (23)

Teva Investigational Site 10564

Portland, Oregon, 97239, United States

Location

Teva Investigational Site 54052

Hradec Králové, 500 05, Czechia

Location

Teva Investigational Site 54051

Olomouc, 775 20, Czechia

Location

Teva Investigational Site 32239

Dresden, 01307, Germany

Location

Teva Investigational Site 32238

Munich, 80336, Germany

Location

Teva Investigational Site 32237

Munich, 80804, Germany

Location

Teva Investigational Site 63044

Athens, 10676, Greece

Location

Teva Investigational Site 63045

Athens, 11527, Greece

Location

Teva Investigational Site 51056

Budapest, 1062, Hungary

Location

Teva Investigational Site 51055

Budapest, 1088, Hungary

Location

Teva Investigational Site 51060

Debrecen, 4012, Hungary

Location

Teva Investigational Site 51061

Győr, H-9023, Hungary

Location

Teva Investigational Site 51059

Pécs, 7624, Hungary

Location

Teva Investigational Site 51057

Szeged, H-6720, Hungary

Location

Teva Investigational Site 51058

Szolnok, 5000, Hungary

Location

Teva Investigational Site 80033

Jerusalem, 91120, Israel

Location

Teva Investigational Site 80032

Petah Tikva, 49100, Israel

Location

Teva Investigational Site 80034

Tel Aviv, 78278, Israel

Location

Teva Investigational Site 61029

Belgrade, 11 000, Serbia

Location

Teva Investigational Site 62017

Bratislava, 826 06, Slovakia

Location

Teva Investigational Site 62022

Bratislava, 833 05, Slovakia

Location

Teva Investigational Site 62016

Ľubochňa, 034 91, Slovakia

Location

Teva Investigational Site 64016

Ljubljana, 1525, Slovenia

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

albusomatropin; Growth Hormone

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 14, 2013
• Study Start: March 31, 2013
• Primary Completion: August 5, 2013
• Study Completion: August 5, 2013
• Last Updated: December 10, 2021

Record last verified: 2021-12

Locations

US (1); IL (3); DE (3); SE (1); SL (3); GR (2); CZ (2); HU (7)