Study of TV-1106 in Growth Hormone-Deficient Adults
- Registration Number
- NCT02410343
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 14
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 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. TV-1106 TV-1106 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.
- Primary Outcome Measures
Name Time Method Body Fat Mass at Baseline, Week 24 and Endpoint in Core Period Baseline (Day 1, pre-dose), Week 24, 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.
- Secondary Outcome Measures
Name Time Method Total Trunk Fat at Baseline, Week 24 and Endpoint in Core Period Baseline (Day 1, pre-dose), Week 24, 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.
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 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.
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 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.
Participants With Adverse Events During the Core Period Day 1 up to 24 Weeks 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.
Participants With Potentially Clinically Significant Abnormal Blood and Urine Test Results Day 1 up to 24 Weeks 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.
Shift From Baseline To Endpoint in Core Period in Electrocardiogram Findings Day 1 up to Week 24 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.
Thyroid Stimulating Hormone (TSH) at Baseline and Endpoint Baseline (Day 1, pre-dose), Endpoint (up to Week 24) One measure of changes in replacement hormones.
Free Thyroxin (Free T4) at Baseline and Endpoint Baseline (Day 1, pre-dose), Endpoint (up to Week 24) One measure of changes in replacement hormones.
Triiodothyronine (Total T3) at Baseline and Endpoint Baseline (Day 1, pre-dose), Endpoint (up to Week 24) One measure of changes in replacement hormones.
Glycated Hemoglobin (HbA1c) at Baseline and Endpoint Baseline (Day 1, pre-dose), Endpoint (up to Week 24) One measure of glucose homeostasis.
Fasting Blood Glucose at Baseline and Endpoint Baseline (Day 1, pre-dose), Endpoint (up to Week 24) One measure of glucose homeostasis.
Insulin at Baseline and Endpoint Baseline (Day 1, pre-dose), Endpoint (up to Week 24) One measure of glucose homeostasis.
Local Tolerability Assessed by Injection Site Reactions Daay 1 up to Week 24 Participants reporting at least one injection site reaction.
Pharmacokinetic Serum Concentration of TV1106 by Nominal Sampling Timepoints Baseline (Day 1, pre-dose), Weeks 4, 8, 12, 16, 24 Weeks 4 and 8 serum samples obtained 2 days after TV1106 administration. Weeks 12 and 24 serum samples obtained 7 days after TV1106 administration. Week 16 serum samples obtained 1 day after TV1106 administration.
Trial Locations
- Locations (33)
Teva Investigational Site 63054
🇬🇷Athens, Greece
Teva Investigational Site 50303
🇷🇺Saint-Petersburg, Russian Federation
Teva Investigational Site 13112
🇺🇸Henderson, Nevada, United States
Teva Investigational Site 51195
ðŸ‡ðŸ‡ºPecs, Hungary
Teva Investigational Site 13127
🇺🇸Fountain Valley, California, United States
Teva Investigational Site 13100
🇺🇸Pembroke Pines, Florida, United States
Teva Investigational Site 13108
🇺🇸Pittsburgh, Pennsylvania, United States
Teva Investigational Site 13121
🇺🇸West Palm Beach, Florida, United States
Teva Investigational Site 51197
ðŸ‡ðŸ‡ºBudapest, Hungary
Teva Investigational Site 30112
🇮🇹Brescia, Italy
Teva Investigational Site 13126
🇺🇸Fountain Valley, California, United States
Teva Investigational Site 13096
🇺🇸Asheville, North Carolina, 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 13101
🇺🇸Detroit, Michigan, United States
Teva Investigational Site 13113
🇺🇸Las Vegas, Nevada, United States
Teva Investigational Site 13107
🇺🇸Houston, Texas, United States
Teva Investigational Site 13120
🇺🇸Houston, Texas, United States
Teva Investigational Site 13097
🇺🇸Houston, Texas, United States
Teva Investigational Site 13494
🇺🇸New York, New York, United States
Teva Investigational Site 13102
🇺🇸Artesia, California, United States
Teva Investigational Site 13124
🇺🇸Evansville, Indiana, United States
Teva Investigational Site 13114
🇺🇸Miami Lakes, Florida, United States
Teva Investigational Site 13104
🇺🇸Chicago, Illinois, United States
Teva Investigational Site 13106
🇺🇸New York, New York, United States
Teva Investigational Site 13125
🇺🇸Dallas, Texas, United States
Teva Investigational Site 13110
🇺🇸Arlington, Texas, United States
Teva Investigational Site 33030
🇦🇹Linz, Austria
Teva Investigational Site 13109
🇺🇸Brooklyn, New York, United States
Teva Investigational Site 63053
🇬🇷Chaidari, Greece
Teva Investigational Site 54112
🇨🇿Moravskoslezsky, Czechia