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

NCT02410356 | Terminated Phase 3

• 1 other identifier: TV1106-IMM-30022
• Study Type: interventional
• Target: 34
• Locations: 8 countries
• Sites: 50

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.

Conditions

Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with adverse events

  Safety of TV-1106 compared to reference drug

  48 weeks

Secondary Outcomes (1)

• Change from baseline in Insulin-like Growth Factor 1 Standard Deviation Score

  Baseline, Weeks: 4, 8, 12, 16, 24, 36, 48

Study Arms (2)

TV-1106

EXPERIMENTAL

TV-1106 to be injected once weekly.

Drug: TV-1106

dGH

ACTIVE COMPARATOR

dGH to be given as daily injections.

Drug: dGH

Interventions

TV-1106 DRUG

The volume necessary to provide the required weekly dose will be calculated by the investigator; dose will be adjusted for IGF-I in the normal range.

Also known as: rhGH

TV-1106

dGH DRUG

The dose levels of dGH will be the same as the stable rhGH dose taken prior to the study.

Also known as: rhGH, Somatropin

dGH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (50)

Teva Investigational Site 13137

Artesia, California, 90701, United States

Location

Teva Investigational Site 13166

Fountain Valley, California, 33155-6541, United States

Location

Teva Investigational Site 13165

Lakewood, California, 90712, United States

Location

Teva Investigational Site 13155

Denver, Colorado, 80209, United States

Location

Teva Investigational Site 13158

Newark, Delaware, 19713, United States

Location

Teva Investigational Site 13162

Fort Lauderdale, Florida, 33312, United States

Location

Teva Investigational Site 13136

Homestead, Florida, 33030, United States

Location

Teva Investigational Site 13138

Miami, Florida, 33126, United States

Location

Teva Investigational Site 13152

Miami, Florida, 33130, United States

Location

Teva Investigational Site 13161

Miami, Florida, 33145, United States

Location

Teva Investigational Site 13500

Miami, Florida, 33155-6541, United States

Location

Teva Investigational Site 13503

Miami, Florida, 33175, United States

Location

Teva Investigational Site 13148

Miami Lakes, Florida, 33016, United States

Location

Teva Investigational Site 13134

Pembroke Pines, Florida, 33024, United States

Location

Teva Investigational Site 13129

West Palm Beach, Florida, 33401, United States

Location

Teva Investigational Site 13135

Detroit, Michigan, 48202, United States

Location

Teva Investigational Site 13146

Henderson, Nevada, 89052, United States

Location

Teva Investigational Site 13147

Las Vegas, Nevada, 89148, United States

Location

Teva Investigational Site 13143

Brooklyn, New York, 11235, United States

Location

Teva Investigational Site 13502

New York, New York, 10016, United States

Location

Teva Investigational Site 13140

New York, New York, 10032, United States

Location

Teva Investigational Site 13128

Asheville, North Carolina, 28803, United States

Location

Teva Investigational Site 13142

Pittsburgh, Pennsylvania, 15212, United States

Location

Teva Investigational Site 13144

Arlington, Texas, 76014, United States

Location

Teva Investigational Site 13163

Dallas, Texas, 75218, United States

Location

Teva Investigational Site 13130

Houston, Texas, 77079, United States

Location

Teva Investigational Site 13141

Houston, Texas, 77084, United States

Location

Teva Investigational Site 13154

Houston, Texas, 77090, United States

Location

Teva Investigational Site 13159

Norfolk, Virginia, 23507, United States

Location

Teva Investigational Site 13504

Federal Way, Washington, 98003, United States

Location

Teva Investigational Site 13164

Seattle, Washington, 98122, United States

Location

Teva Investigational Site 13157

Tacoma, Washington, 98405, United States

Location

Teva Investigational Site 33035

Linz, A-4020, Austria

Location

Teva Investigational Site 54118

Brno, 656 91, Czechia

Location

Teva Investigational Site 54119

Moravskoslezsky, 708 00, Czechia

Location

Teva Investigational Site 54116

Plzensky, 304 60, Czechia

Location

Teva Investigational Site 63059

Athens, 11527, Greece

Location

Teva Investigational Site 63058

Chaïdári, 12462, Greece

Location

Teva Investigational Site 63060

Ioannina, Greece

Location

Teva Investigational Site 51202

Budapest, 1062, Hungary

Location

Teva Investigational Site 51206

Budapest, 1088, Hungary

Location

Teva Investigational Site 51205

Debrecen, 4032, Hungary

Location

Teva Investigational Site 51204

Pécs, 7624, Hungary

Location

Teva Investigational Site 51208

Szeged, 6725, Hungary

Location

Teva Investigational Site 51207

Szolnok, 5000, Hungary

Location

Teva Investigational Site 30129

Brescia, 25018, Italy

Location

Teva Investigational Site 62041

Ľubochňa, 034 91, Slovakia

Location

Teva Investigational Site 31129

Badalona, 08916, Spain

Location

Teva Investigational Site 31121

Córdoba, 14004, Spain

Location

Teva Investigational Site 31125

Madrid, 28805, Spain

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

albusomatropin; Human Growth Hormone

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 7, 2015
• Study Start: April 30, 2015
• Primary Completion: February 29, 2016
• Study Completion: April 30, 2016
• Last Updated: December 10, 2021

Record last verified: 2021-12

Locations

ES (3); AU (1); GR (3); SL (1); HU (6); IT (1); US (32); CZ (3)