Study of TV-1106 in Growth Hormone-Deficient Adults
Condition: Growth Hormone Deficiency
Intervention: TV-1106; Placebo
Intervention description: A starting dose of 5.0 mg was expected to be appropriate for most patients because the daily recommended starting dose of recombinant human growth hormone (rhGH) treatments (e.g. somatropin) is 0.2 mg/day, and the conversion factor was 28. Dosage could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 until the participant's insulin-like growth factor 1 (IGF-1) standard deviation score (SDS) was within the range of -0.5 to +1.5.; Placebo treatment was administered in a blinded fashion and titrated on weeks 4, 8, 12 and 16 to mimic the active treatment.
Intervention MeSH terms: Hormones
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: long acting growth hormone

Summary:

      The primary objective of this study is to determine the efficacy of 6 months of treatment
      with TV-1106 compared with placebo on body fat composition.
    

Eligibility criteria:

        Inclusion:

          -  males and females 18 years of age or over

          -  diagnosis of adult growth hormone deficiency (GHD) for at least 6 months, or patients
             who have hypopituitarism from surgical resection

          -  no history of exposure to any rhGH within the past 12 months prior to screening

          -  stable, adequate doses of replacement hormones (adrenal, thyroid, estrogen,
             testosterone, vasopressin) for at least 3 months prior to screening

               -  Other criteria apply, please contact the investigator for more information

        Exclusion:

          -  patients with acute or chronic conditions or diseases that could confound results of
             the study or put the patient at undue risk as determined by the investigator

          -  Presence of contraindications to rhGH treatment

          -  patients who have participated in another clinical trial with a new
             chemical/biological entity within 3 months of screening

          -  patients with known active malignancy (excluding surgically removed basal cell
             carcinoma or carcinoma in situ of cervix)

          -  patients with a previously treated pituitary tumor with evidence of tumor progression
             in the past year patients with a new diagnosis of pituitary adenoma or other
             intracranial tumor within 12 months of screening

          -  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

          -  patients with type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus
             as indicated by a glycated hemoglobin (HBA1c) of ≥8%

          -  patients using weight reducing agents or appetite suppressants

          -  women who are pregnant or nursing, or planning pregnancy during the study period

               -  Other criteria apply, please contact the investigator for more information