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

Phase 3

Terminated

• Conditions: Growth Hormone Deficiency
• Interventions: Drug: TV-1106; Drug: dGH

• Registration Number: NCT02410356
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-30
• Study First Submitted QC: 2015-04-01
• Study First Posted: 2015-04-07
• Study Start: 2015-04-30
• Primary Completion: 2016-02-29
• Study Completion: 2016-04-30
• Disposition First Submitted: 2018-04-16
• Disposition First Submitted QC: 2018-04-16
• Disposition First Posted: 2018-04-18
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-08
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TV-1106	TV-1106	TV-1106 to be injected once weekly.
dGH	dGH	dGH to be given as daily injections.

Primary Outcome Measures

Name	Time	Method
Percentage of participants with adverse events	48 weeks	Safety of TV-1106 compared to reference drug

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Insulin-like Growth Factor 1 Standard Deviation Score	Baseline, Weeks: 4, 8, 12, 16, 24, 36, 48

Trial Locations

Locations (50)

Teva Investigational Site 13137; 🇺🇸 Artesia, California, United States

Teva Investigational Site 13166; 🇺🇸 Fountain Valley, California, United States

Teva Investigational Site 13165; 🇺🇸 Lakewood, California, United States

Teva Investigational Site 13155; 🇺🇸 Denver, Colorado, United States

Teva Investigational Site 13158; 🇺🇸 Newark, Delaware, United States

Teva Investigational Site 13162; 🇺🇸 Fort Lauderdale, Florida, United States

Teva Investigational Site 13136; 🇺🇸 Homestead, Florida, United States

Teva Investigational Site 13148; 🇺🇸 Miami Lakes, Florida, United States

Teva Investigational Site 13138; 🇺🇸 Miami, Florida, United States

Teva Investigational Site 13152; 🇺🇸 Miami, Florida, United States

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