Study of TV-1106 in Growth Hormone-Deficient Adults

January 20, 2022 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy, Safety and Tolerability Study of TV-1106 in Growth Hormone-Deficient Adults Who Are Not Current Users of rhGH Treatment

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, A-4020
        • Teva Investigational Site 33030
  • Czechia
      • Moravskoslezsky, Czechia, 708 00
        • Teva Investigational Site 54112
  • Greece
      • Athens, Greece, 11527
        • Teva Investigational Site 63054
      • Chaidari, Greece, 12462
        • Teva Investigational Site 63053
  • Hungary
      • Budapest, Hungary, 1088
        • Teva Investigational Site 51197
      • Pecs, Hungary, 7624
        • Teva Investigational Site 51195
  • Italy
      • Brescia, Italy, 25018
        • Teva Investigational Site 30112
  • Russian Federation
      • Saint-Petersburg, Russian Federation
        • Teva Investigational Site 50303
  • United States
    • California
      • Artesia, California, United States, 90701
        • Teva Investigational Site 13102
      • Fountain Valley, California, United States, 33155-6541
        • Teva Investigational Site 13127
      • Fountain Valley, California, United States, 92708
        • Teva Investigational Site 13126
    • Florida
      • Miami, Florida, United States, 33126
        • Teva Investigational Site 13103
      • Miami, Florida, United States, 33130
        • Teva Investigational Site 13118
      • Miami, Florida, United States, 33145
        • Teva Investigational Site 13123
      • Miami, Florida, United States, 33155-6541
        • Teva Investigational Site 13492
      • Miami Lakes, Florida, United States, 33016
        • Teva Investigational Site 13114
      • Pembroke Pines, Florida, United States, 33024
        • Teva Investigational Site 13100
      • West Palm Beach, Florida, United States, 33401
        • Teva Investigational Site 13121
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Teva Investigational Site 13104
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Teva Investigational Site 13124
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Teva Investigational Site 13101
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Teva Investigational Site 13112
      • Las Vegas, Nevada, United States, 89148
        • Teva Investigational Site 13113
    • New York
      • Brooklyn, New York, United States, 11235
        • Teva Investigational Site 13109
      • New York, New York, United States, 10016
        • Teva Investigational Site 13494
      • New York, New York, United States, 10032
        • Teva Investigational Site 13106
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Teva Investigational Site 13096
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Teva Investigational Site 13108
    • Texas
      • Arlington, Texas, United States, 76014
        • Teva Investigational Site 13110
      • Dallas, Texas, United States, 75218
        • Teva Investigational Site 13125
      • Houston, Texas, United States, 77079
        • Teva Investigational Site 13097
      • Houston, Texas, United States, 77084
        • Teva Investigational Site 13107
      • Houston, Texas, United States, 77090
        • Teva Investigational Site 13120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Placebo
Placebo treatment was administered in a blinded fashion and titrated on weeks 4, 8, 12 and 16 to mimic the active treatment.
Other Names:
  • Matching placebo
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.
Drug: TV-1106
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.
Other Names:
  • long-acting growth hormone, albutropin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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.
Baseline (Day 1, pre-dose), Week 24, Endpoint in Core period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
Time Frame: 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.
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
Time Frame: 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.
Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period
Participants With Adverse Events During the Core Period
Time Frame: 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.
Day 1 up to 24 Weeks
Participants With Potentially Clinically Significant Abnormal Blood and Urine Test Results
Time Frame: 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.
Day 1 up to 24 Weeks
Shift From Baseline To Endpoint in Core Period in Electrocardiogram Findings
Time Frame: 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.
Day 1 up to Week 24
Thyroid Stimulating Hormone (TSH) at Baseline and Endpoint
Time Frame: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
One measure of changes in replacement hormones.
Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Free Thyroxin (Free T4) at Baseline and Endpoint
Time Frame: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
One measure of changes in replacement hormones.
Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Triiodothyronine (Total T3) at Baseline and Endpoint
Time Frame: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
One measure of changes in replacement hormones.
Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Glycated Hemoglobin (HbA1c) at Baseline and Endpoint
Time Frame: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
One measure of glucose homeostasis.
Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Fasting Blood Glucose at Baseline and Endpoint
Time Frame: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
One measure of glucose homeostasis.
Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Insulin at Baseline and Endpoint
Time Frame: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
One measure of glucose homeostasis.
Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Local Tolerability Assessed by Injection Site Reactions
Time Frame: Daay 1 up to Week 24
Participants reporting at least one injection site reaction.
Daay 1 up to Week 24
Pharmacokinetic Serum Concentration of TV1106 by Nominal Sampling Timepoints
Time Frame: 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.
Baseline (Day 1, pre-dose), Weeks 4, 8, 12, 16, 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TV1106-IMM-30021
  • 2014-003796-32 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Growth Hormone Deficiency

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings