Skip to content

Trial · Interventional

TerminatedPhase 3Results postedRegistry data

Study of TV-1106 in Growth Hormone-Deficient Adults

NCTNCT02410343 (opens ClinicalTrials.gov in a new tab)Other idTV1106-IMM-30021Other id2014-003796-32Other id2014
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures IGF-1 (mecasermin), does not give it. It appears in an outcome measure.
  • Names HGH (somatotropin), does not test it. It appears in the description.

Overview

Status
Terminated
Phase
Phase 3
Enrollment
14 participants (actual)
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. · Industry
Design
Randomized · Quadruple masking
Countries
7 countries

United States, Austria, Czechia, Greece, Hungary, Italy, Russia

Start
30 Apr 2015
Primary completion
31 Dec 2015
Completion
31 Dec 2015
First posted
7 Apr 2015 (estimated)
Last update posted
24 Jan 2022
Conditions
Growth Hormone Deficiency

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20152016
  1. Ph 3

    Study of TV-1106 in Growth Hormone-Deficient Adults

    NCT02410343

    30 Apr 2015 to 31 Dec 2015

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TV-1106Drug
  • PlaceboDrug

Arms2

  • Placebo comparator

    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.

  • Experimental

    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 outcomes1

Outcomes the sponsor listed as primary.

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

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

    Registry description

    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 outcomes(14)

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

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

    Registry description

    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.

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

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

    Registry description

    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.

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

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

    Registry description

    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.

  4. Participants With Adverse Events During the Core Period

    Time frame · Day 1 up to 24 Weeks

    Registry description

    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.

  5. Participants With Potentially Clinically Significant Abnormal Blood and Urine Test Results

    Time frame · Day 1 up to 24 Weeks

    Registry description

    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.

  6. Shift From Baseline To Endpoint in Core Period in Electrocardiogram Findings

    Time frame · Day 1 up to Week 24

    Registry description

    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.

  7. Thyroid Stimulating Hormone (TSH) at Baseline and Endpoint

    Time frame · Baseline (Day 1, pre-dose), Endpoint (up to Week 24)

    Registry description

    One measure of changes in replacement hormones.

  8. Free Thyroxin (Free T4) at Baseline and Endpoint

    Time frame · Baseline (Day 1, pre-dose), Endpoint (up to Week 24)

    Registry description

    One measure of changes in replacement hormones.

  9. Triiodothyronine (Total T3) at Baseline and Endpoint

    Time frame · Baseline (Day 1, pre-dose), Endpoint (up to Week 24)

    Registry description

    One measure of changes in replacement hormones.

  10. Glycated Hemoglobin (HbA1c) at Baseline and Endpoint

    Time frame · Baseline (Day 1, pre-dose), Endpoint (up to Week 24)

    Registry description

    One measure of glucose homeostasis.

  11. Fasting Blood Glucose at Baseline and Endpoint

    Time frame · Baseline (Day 1, pre-dose), Endpoint (up to Week 24)

    Registry description

    One measure of glucose homeostasis.

  12. Insulin at Baseline and Endpoint

    Time frame · Baseline (Day 1, pre-dose), Endpoint (up to Week 24)

    Registry description

    One measure of glucose homeostasis.

  13. Local Tolerability Assessed by Injection Site Reactions

    Time frame · Daay 1 up to Week 24

    Registry description

    Participants reporting at least one injection site reaction.

  14. Pharmacokinetic Serum Concentration of TV1106 by Nominal Sampling Timepoints

    Time frame · Baseline (Day 1, pre-dose), Weeks 4, 8, 12, 16, 24

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

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

GroupValue (kg)Spread
Placebo24.387.495
TV-110629.5010.922
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period

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

GroupValue (kg)Spread
Placebo12.024.716
TV-110615.055.041
Secondary outcomeMean· 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

GroupValue (standard deviation score)Spread
Placebo-2.000.978
TV-1106-1.400.545
Secondary outcomeMean· 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

GroupValue (units on a scale)Spread
Placebo3.85.46
TV-11069.68.14
Secondary outcomeCount of participants· Day 1 up to 24 Weeks

Participants With Adverse Events During the Core Period

GroupValue (Participants)
Placebo3
TV-11064
Secondary outcomeCount of participants· Day 1 up to 24 Weeks

Participants With Potentially Clinically Significant Abnormal Blood and Urine Test Results

GroupValue (Participants)
Placebo0
TV-11061
Secondary outcomeCount of participants· Day 1 up to Week 24

Shift From Baseline To Endpoint in Core Period in Electrocardiogram Findings

GroupValue (Participants)
Placebo4
TV-11066
Secondary outcomeMean· Baseline (Day 1, pre-dose), Endpoint (up to Week 24)

Thyroid Stimulating Hormone (TSH) at Baseline and Endpoint

GroupValue (MIU/L)Spread
Placebo0.3650.3791
TV-11061.0282.0259

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Placebo - Core PeriodPlacebo was injected subcutaneously once weekly on the same day and time for 24 weeks during the Core Period. 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. Participants who completed the Core Period were eligible to enter an open-label extension phase for 12 additional months where all participants received treatment with TV-1106.0 / 61 / 63 / 6
TV-1106 - Core PeriodTV-1106 was injected subcutaneously once weekly on the same day and time for 24 weeks during the Core Period. 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. Participants who completed the Core Period were eligible to enter an open-label extension phase for 12 additional months where all participants received treatment with TV-1106.0 / 80 / 84 / 8
TV-1106 - Extension PeriodParticipants from both the Placebo and TV-1106 groups who completed the Core Period were eligible to enter an open-label extension phase for 12 additional months where all participants received treatment with TV-1106. Due to early termination of the study, two participants spent a maximum of two weeks in the extension period.0 / 20 / 21 / 2

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.