Study of TV-1106 in Growth Hormone-Deficient Adults

Phase 3TerminatedNCT02410343

Teva Branded Pharmaceutical Products R&D, Inc.14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Growth Hormone Deficiency

Interventions

TV-1106DRUG

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.

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (33)

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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

Trunk fat (kg) was assessed based on DXA results. Trunk fat was defined as fat mass - (total arm fat + total leg fat + total head fat). The outcome as defined in the protocol was the within-patient change from baseline to week 24 in trunk fat. Due to the early termination of the study, observed values including endpoint values are reported. Endpoint is the last observed value.

Time frame: 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

IGF-I SDS, as reported by the central laboratory, was a key secondary variable. The week 24 value is a trough value as it was taken 7 days after the last TV-1106 or placebo injection. The outcome as defined in the protocol was the within-patient change from baseline to week 24. Due to the early termination of the study, observed values including endpoint values are reported. Endpoint is the last observed value and is of variable length of time since last TV-1106 or placebo injection.

Time frame: 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

The AGHDA instrument is comprised of 25 questions, with yes or no answers. To each of the 25 questions comprising QOL AGHDA, a score of 1 was assigned if the answer was affirmative and 0 if the answer was negative. Data reported is the total score across the 25 questions for a total range of 0-25 with higher scores representing a poorer quality of life. The outcome as defined in the protocol was the within-patient change from baseline to week 24. Due to the early termination of the study, observed values including endpoint values are reported. Endpoint is the last observed value.

Data from ClinicalTrials.gov

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Teva Investigational Site 13102

Artesia, California, United States

Teva Investigational Site 13127

Fountain Valley, California, United States

Teva Investigational Site 13126

Fountain Valley, California, United States

Teva Investigational Site 13103

Miami, Florida, United States

Teva Investigational Site 13118

Miami, Florida, United States

Teva Investigational Site 13123

Miami, Florida, United States

Teva Investigational Site 13492

Miami, Florida, United States

Teva Investigational Site 13114

Miami Lakes, Florida, United States

Teva Investigational Site 13100

Pembroke Pines, Florida, United States

Teva Investigational Site 13121

West Palm Beach, Florida, United States

...and 23 more locations

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

Participants With Adverse Events During the Core Period

An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents usual activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.

Time frame: Day 1 up to 24 Weeks

Participants With Potentially Clinically Significant Abnormal Blood and Urine Test Results

Parameters with potentially clinically significant abnormal test results include - Serum chemistry: blood urea nitrogen, creatinine and bilirubin - Hematology: leukocytes, hemoglobin, hematocrit, platelets and neutrophils - Urinalysis: none Significance criteria are listed below with the test.

Time frame: Day 1 up to 24 Weeks

Shift From Baseline To Endpoint in Core Period in Electrocardiogram Findings

Shifts represented as baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicates an abnormal but not clinically significant finding. Abnormal CS indicates an abnormal and clinically significant finding.

Time frame: Day 1 up to Week 24

Thyroid Stimulating Hormone (TSH) at Baseline and Endpoint

One measure of changes in replacement hormones.