Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency (NCT01811576) | Clinical Trial Compass
CompletedPhase 2
Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency
United States, Czechia, Germany52 participantsStarted 2013-03-31
Plain-language summary
The primary objective of this study is to evaluate the clinical effect of TV-1106.
Who can participate
Age range23 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Insulin-like growth factor I (IGF-I) concentration change from baseline
Timeframe: Baseline to Week 12
Trial details
NCT IDNCT01811576
SponsorTeva Branded Pharmaceutical Products R&D, Inc.