Study to Assess Safety and Tolerability in Adults With Growth Hormone-Deficiency (GHD)

Teva Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Growth Hormone Deficiency

Treatments: Drug: TV-1106; Drug: dGH

Study type: Interventional

Funder types: Industry

Identifiers

NCT02410356

TV1106-IMM-30022

Details and patient eligibility

About

This study assesses the safety and tolerability of weekly TV-1106 compared to daily rhGH in adults with GHD who have previously been treated with rhGH.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• males and females 18 years of age or over

• diagnosis of adult GHD for at least 6 months, or patients who have hypopituitarism from surgical resection

• treated with a stable dose of daily rhGH for at least 3 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 criteria

• 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) d. 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 year.

• patients with type 1 diabetes mellitus oror poorly controlled type 2 diabetes mellitus as indicated by a glycated hemoglobin (HbA1c) ≥8%

• patients using weight reducing agents or appetite suppressants

  • Other criteria apply, please contact the investigator for more information

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

TV-1106

Experimental group

Description:

TV-1106 to be injected once weekly.

Treatment:

Drug: TV-1106

dGH

Active Comparator group

Description:

dGH to be given as daily injections.

Treatment:

Drug: dGH