Study of TV-1106 in Growth Hormone-Deficient Adults

NCT02410343 | Terminated Phase 3 Results DMC

• 2 other identifiers: TV1106-IMM-300212014-003796-32
• Study Type: interventional
• Target: 14
• Locations: 7 countries
• Sites: 33

Brief 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.

Conditions

Growth Hormone Deficiency

Keywords

long acting growth hormone

Outcome Measures

Primary Outcomes (1)

• Body Fat Mass at Baseline, Week 24 and Endpoint in Core Period

  The primary efficacy measure for the study was body fat mass (kg) measured by DXA imaging. The primary outcome as defined in the protocol was the change from baseline to week 24 in body fat mass. Due to the early termination of the study, observed values including endpoint values are reported. Endpoint is the last observed value.

  Baseline (Day 1, pre-dose), Week 24, Endpoint in Core period

Secondary Outcomes (14)

• Total Trunk Fat at Baseline, Week 24 and Endpoint in Core Period

  Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period

• Insulin-Like Growth Factor 1 Standard Deviation Score (IGF-I SDS) at Baseline, Week 24 and Endpoint in Core Period

  Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period

• Scored Analysis of Quality of Life Assessment of GH Deficiency in Adults (QoL-AGHDA) at Baseline, Week 24 and Endpoint in Core Period

  Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period

• Participants With Adverse Events During the Core Period

  Day 1 up to 24 Weeks

• Participants With Potentially Clinically Significant Abnormal Blood and Urine Test Results

  Day 1 up to 24 Weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

TV-1106

EXPERIMENTAL

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.

Drug: TV-1106

Interventions

TV-1106 DRUG

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.

Also known as: long-acting growth hormone, albutropin

TV-1106

Placebo DRUG

Placebo treatment was administered in a blinded fashion and titrated on weeks 4, 8, 12 and 16 to mimic the active treatment.

Also known as: Matching placebo

Placebo

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 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

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)
• 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

Sponsors & Collaborators

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

Study Sites (33)

Teva Investigational Site 13102

Artesia, California, 90701, United States

Location

Teva Investigational Site 13127

Fountain Valley, California, 33155-6541, United States

Location

Teva Investigational Site 13126

Fountain Valley, California, 92708, United States

Location

Teva Investigational Site 13103

Miami, Florida, 33126, United States

Location

Teva Investigational Site 13118

Miami, Florida, 33130, United States

Location

Teva Investigational Site 13123

Miami, Florida, 33145, United States

Location

Teva Investigational Site 13492

Miami, Florida, 33155-6541, United States

Location

Teva Investigational Site 13114

Miami Lakes, Florida, 33016, United States

Location

Teva Investigational Site 13100

Pembroke Pines, Florida, 33024, United States

Location

Teva Investigational Site 13121

West Palm Beach, Florida, 33401, United States

Location

Teva Investigational Site 13104

Chicago, Illinois, 60612, United States

Location

Teva Investigational Site 13124

Evansville, Indiana, 47714, United States

Location

Teva Investigational Site 13101

Detroit, Michigan, 48202, United States

Location

Teva Investigational Site 13112

Henderson, Nevada, 89052, United States

Location

Teva Investigational Site 13113

Las Vegas, Nevada, 89148, United States

Location

Teva Investigational Site 13109

Brooklyn, New York, 11235, United States

Location

Teva Investigational Site 13494

New York, New York, 10016, United States

Location

Teva Investigational Site 13106

New York, New York, 10032, United States

Location

Teva Investigational Site 13096

Asheville, North Carolina, 28803, United States

Location

Teva Investigational Site 13108

Pittsburgh, Pennsylvania, 15212, United States

Location

Teva Investigational Site 13110

Arlington, Texas, 76014, United States

Location

Teva Investigational Site 13125

Dallas, Texas, 75218, United States

Location

Teva Investigational Site 13097

Houston, Texas, 77079, United States

Location

Teva Investigational Site 13107

Houston, Texas, 77084, United States

Location

Teva Investigational Site 13120

Houston, Texas, 77090, United States

Location

Teva Investigational Site 33030

Linz, A-4020, Austria

Location

Teva Investigational Site 54112

Moravskoslezsky, 708 00, Czechia

Location

Teva Investigational Site 63054

Athens, 11527, Greece

Location

Teva Investigational Site 63053

Chaïdári, 12462, Greece

Location

Teva Investigational Site 51197

Budapest, 1088, Hungary

Location

Teva Investigational Site 51195

Pécs, 7624, Hungary

Location

Teva Investigational Site 30112

Brescia, 25018, Italy

Location

Teva Investigational Site 50303

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

albusomatropin

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

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Teva Branded Pharmaceutical Products

Public_CTD@tevapharm.com

215-591-3000

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• 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: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: January 24, 2022
• Results First Posted: June 11, 2018

Record last verified: 2022-01

Locations

AU (1); IT (1); US (25); RU (1); GR (2); HU (2); CZ (1)