Study of TV-1106 in Growth Hormone-Deficient Adults

Teva Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Growth Hormone Deficiency

Treatments: Drug: Placebo; Drug: TV-1106

Study type: Interventional

Funder types: Industry

Identifiers

NCT02410343

TV1106-IMM-30021

2014-003796-32 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

14 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo was injected subcutaneously once weekly on the same day and time for 24 weeks. To maintain the blind, placebo could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 to match the effect of dose titration.

Treatment:

Drug: Placebo

TV-1106

Experimental group

Description:

TV-1106 was injected subcutaneously once weekly on the same day and time for 24 weeks. A common starting dose was 5.0 mg. Doses 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.

Treatment:

Drug: TV-1106