Trial · NCT02410343

Study of TV-1106 in Growth Hormone-Deficient Adults

NCT02410343, Phase 3, Terminated, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2018-06-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of TV-1106 in Growth Hormone-Deficient Adults. Trials, record NCT02410343. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02410343

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of TV-1106 in Growth Hormone-Deficient Adults
NCT number: NCT02410343
Status: Terminated
Phases: Phase 3
Enrollment: 14 participants, actual
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Conditions: Growth Hormone Deficiency
Interventions: TV-1106, Placebo
First posted: 2015-04-07
Last updated: 2022-01-24
Other registries' IDs: eudract:2014-003796-32
Results first posted: 2018-06-11

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Body Fat Mass at Baseline, Week 24 and Endpoint in Core Period	Baseline (Day 1, pre-dose), Week 24, Endpoint in Core period	ITT	kg	MEAN
SECONDARY	Total Trunk Fat at Baseline, Week 24 and Endpoint in Core Period	Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period	ITT	kg	MEAN
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	ITT	standard deviation score	MEAN
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	ITT	units on a scale	MEAN
SECONDARY	Participants With Adverse Events During the Core Period	Day 1 up to 24 Weeks	Safety population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Participants With Potentially Clinically Significant Abnormal Blood and Urine Test Results	Day 1 up to 24 Weeks	Safety population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Shift From Baseline To Endpoint in Core Period in Electrocardiogram Findings	Day 1 up to Week 24	Safety population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Thyroid Stimulating Hormone (TSH) at Baseline and Endpoint	Baseline (Day 1, pre-dose), Endpoint (up to Week 24)	Safety population of participants reporting data	MIU/L	MEAN
SECONDARY	Free Thyroxin (Free T4) at Baseline and Endpoint	Baseline (Day 1, pre-dose), Endpoint (up to Week 24)	Safety population of participants reporting data	PMOL/L	MEAN
SECONDARY	Triiodothyronine (Total T3) at Baseline and Endpoint	Baseline (Day 1, pre-dose), Endpoint (up to Week 24)	Safety population of participants reporting data	NMOL/L	MEAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group104

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Body Fat Mass at Baseline, Week 24 and Endpoint in Core Period	Placebo	Baseline	24.38	Standard Deviation 7.495	kg
Body Fat Mass at Baseline, Week 24 and Endpoint in Core Period	TV-1106	Baseline	29.50	Standard Deviation 10.922	kg
Body Fat Mass at Baseline, Week 24 and Endpoint in Core Period	Placebo	Week 24	28.90	Standard Deviation NA	kg
Body Fat Mass at Baseline, Week 24 and Endpoint in Core Period	TV-1106	Week 24	31.80	Standard Deviation NA	kg
Body Fat Mass at Baseline, Week 24 and Endpoint in Core Period	Placebo	Endpoint	23.27	Standard Deviation 7.389	kg
Body Fat Mass at Baseline, Week 24 and Endpoint in Core Period	TV-1106	Endpoint	31.05	Standard Deviation 13.256	kg
Total Trunk Fat at Baseline, Week 24 and Endpoint in Core Period	Placebo	Baseline	12.02	Standard Deviation 4.716	kg
Total Trunk Fat at Baseline, Week 24 and Endpoint in Core Period	TV-1106	Baseline	15.05	Standard Deviation 5.041	kg
Total Trunk Fat at Baseline, Week 24 and Endpoint in Core Period	Placebo	Week 24	15.60	Standard Deviation NA	kg
Total Trunk Fat at Baseline, Week 24 and Endpoint in Core Period	TV-1106	Week 24	12.60	Standard Deviation NA	kg

1 to 10 of 104Source ClinicalTrials.gov

See all 104 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Core Period (24 Weeks)	STARTED	Placebo	6
Core Period (24 Weeks)	STARTED	TV-1106	8
Core Period (24 Weeks)	COMPLETED	Placebo	1
Core Period (24 Weeks)	COMPLETED	TV-1106	1
Core Period (24 Weeks)	NOT COMPLETED	Placebo	5
Core Period (24 Weeks)	NOT COMPLETED	TV-1106	7
Extension Period (12 Months)	STARTED	Placebo	1
Extension Period (12 Months)	STARTED	TV-1106	1
Extension Period (12 Months)	COMPLETED	Placebo	0
Extension Period (12 Months)	COMPLETED	TV-1106	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events33

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Injection site pain	General disorders	Placebo - Core Period	0	6
other	Injection site pain	General disorders	TV-1106 - Core Period	2	8	2
other	Injection site pain	General disorders	TV-1106 - Extension Period	0	2
other	Injection site swelling	General disorders	Placebo - Core Period	0	6
other	Injection site swelling	General disorders	TV-1106 - Core Period	0	8
other	Injection site swelling	General disorders	TV-1106 - Extension Period	1	2	2
other	Injection site rash	General disorders	Placebo - Core Period	0	6
other	Injection site rash	General disorders	TV-1106 - Core Period	0	8
other	Injection site rash	General disorders	TV-1106 - Extension Period	1	2	1
other	Upper respiratory tract infection	Infections and infestations	Placebo - Core Period	1	6	1

1 to 10 of 33Source ClinicalTrials.gov

See all 33 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo - Core Period	0	6
Total, all-cause mortality	TV-1106 - Core Period	0	8
Total, all-cause mortality	TV-1106 - Extension Period	0	2
Total, other adverse events	Placebo - Core Period	3	6
Total, other adverse events	TV-1106 - Core Period	4	8
Total, other adverse events	TV-1106 - Extension Period	1	2
Total, serious adverse events	Placebo - Core Period	1	6
Total, serious adverse events	TV-1106 - Core Period	0	8
Total, serious adverse events	TV-1106 - Extension Period	0	2

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02410343

GET https://conductscience.org/api/trials/v1/NCT02410343/results?page=2

API reference For AI assistants