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

Teva Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Growth Hormone Deficiency

Treatments

Drug: TV-1106

Drug: Recombinant human growth hormone

Study type

Interventional

Funder types

Industry

Identifiers

TV1106-GHD-201

2012-004975-37 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

52 patients

Sex

All

Ages

23 to 65 years old

Volunteers

No Healthy Volunteers

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.