Trial · NCT02410343
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | Triiodothyronine (Total T3) at Baseline and Endpoint | Baseline (Day 1, pre-dose), Endpoint (up to Week 24) | One measure of changes in replacement hormones. |
| Secondary | Glycated Hemoglobin (HbA1c) at Baseline and Endpoint | Baseline (Day 1, pre-dose), Endpoint (up to Week 24) | One measure of glucose homeostasis. |
| Secondary | Fasting Blood Glucose at Baseline and Endpoint | Baseline (Day 1, pre-dose), Endpoint (up to Week 24) | One measure of glucose homeostasis. |
| Secondary | Insulin at Baseline and Endpoint | Baseline (Day 1, pre-dose), Endpoint (up to Week 24) | One measure of glucose homeostasis. |
| Secondary | Local Tolerability Assessed by Injection Site Reactions | Daay 1 up to Week 24 | Participants reporting at least one injection site reaction. |
| Secondary | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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