Study to Assess Safety and Tolerability in Adults With Growth Hormone-Deficiency (GHD)

December 8, 2021 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

A Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (Genotropin(R)) in Adults With Growth Hormone-Deficiency

This study assesses the safety and tolerability of weekly TV-1106 compared to daily rhGH in adults with GHD who have previously been treated with rhGH.

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.
34

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 33035
  • Czechia
      • Brno, Czechia, 656 91
        • Teva Investigational Site 54118
      • Moravskoslezsky, Czechia, 708 00
        • Teva Investigational Site 54119
      • Plzensky, Czechia, 304 60
        • Teva Investigational Site 54116
  • Greece
      • Athens, Greece, 11527
        • Teva Investigational Site 63059
      • Chaidari, Greece, 12462
        • Teva Investigational Site 63058
      • Ioannina, Greece
        • Teva Investigational Site 63060
  • Hungary
      • Budapest, Hungary, 1062
        • Teva Investigational Site 51202
      • Budapest, Hungary, 1088
        • Teva Investigational Site 51206
      • Debrecen, Hungary, 4032
        • Teva Investigational Site 51205
      • Pecs, Hungary, 7624
        • Teva Investigational Site 51204
      • Szeged, Hungary, 6725
        • Teva Investigational Site 51208
      • Szolnok, Hungary, 5000
        • Teva Investigational Site 51207
  • Italy
      • Brescia, Italy, 25018
        • Teva Investigational Site 30129
  • Slovakia
      • Lubochna, Slovakia, 034 91
        • Teva Investigational Site 62041
  • Spain
      • Badalona, Spain, 08916
        • Teva Investigational Site 31129
      • Cordoba, Spain, 14004
        • Teva Investigational Site 31121
      • Madrid, Spain, 28805
        • Teva Investigational Site 31125
  • United States
    • California
      • Artesia, California, United States, 90701
        • Teva Investigational Site 13137
      • Fountain Valley, California, United States, 33155-6541
        • Teva Investigational Site 13166
      • Lakewood, California, United States, 90712
        • Teva Investigational Site 13165
    • Colorado
      • Denver, Colorado, United States, 80209
        • Teva Investigational Site 13155
    • Delaware
      • Newark, Delaware, United States, 19713
        • Teva Investigational Site 13158
    • Florida
      • Fort Lauderdale, Florida, United States, 33312
        • Teva Investigational Site 13162
      • Homestead, Florida, United States, 33030
        • Teva Investigational Site 13136
      • Miami, Florida, United States, 33126
        • Teva Investigational Site 13138
      • Miami, Florida, United States, 33130
        • Teva Investigational Site 13152
      • Miami, Florida, United States, 33145
        • Teva Investigational Site 13161
      • Miami, Florida, United States, 33155-6541
        • Teva Investigational Site 13500
      • Miami, Florida, United States, 33175
        • Teva Investigational Site 13503
      • Miami Lakes, Florida, United States, 33016
        • Teva Investigational Site 13148
      • Pembroke Pines, Florida, United States, 33024
        • Teva Investigational Site 13134
      • West Palm Beach, Florida, United States, 33401
        • Teva Investigational Site 13129
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Teva Investigational Site 13135
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Teva Investigational Site 13146
      • Las Vegas, Nevada, United States, 89148
        • Teva Investigational Site 13147
    • New York
      • Brooklyn, New York, United States, 11235
        • Teva Investigational Site 13143
      • New York, New York, United States, 10016
        • Teva Investigational Site 13502
      • New York, New York, United States, 10032
        • Teva Investigational Site 13140
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Teva Investigational Site 13128
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Teva Investigational Site 13142
    • Texas
      • Arlington, Texas, United States, 76014
        • Teva Investigational Site 13144
      • Dallas, Texas, United States, 75218
        • Teva Investigational Site 13163
      • Houston, Texas, United States, 77079
        • Teva Investigational Site 13130
      • Houston, Texas, United States, 77084
        • Teva Investigational Site 13141
      • Houston, Texas, United States, 77090
        • Teva Investigational Site 13154
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Teva Investigational Site 13159
    • Washington
      • Federal Way, Washington, United States, 98003
        • Teva Investigational Site 13504
      • Seattle, Washington, United States, 98122
        • Teva Investigational Site 13164
      • Tacoma, Washington, United States, 98405
        • Teva Investigational Site 13157

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 Criteria:

  • males and females 18 years of age or over
  • diagnosis of adult GHD for at least 6 months, or patients who have hypopituitarism from surgical resection
  • treated with a stable dose of daily rhGH for at least 3 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 Criteria:

  • 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) d. 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 year.
  • patients with type 1 diabetes mellitus oror poorly controlled type 2 diabetes mellitus as indicated by a glycated hemoglobin (HbA1c) ≥8%

  • patients using weight reducing agents or appetite suppressants

    • 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: None (Open Label)

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.
Experimental: TV-1106
TV-1106 to be injected once weekly.
Drug: TV-1106
The volume necessary to provide the required weekly dose will be calculated by the investigator; dose will be adjusted for IGF-I in the normal range.
Other Names:
  • rhGH
Active Comparator: dGH
dGH to be given as daily injections.
Drug: dGH
The dose levels of dGH will be the same as the stable rhGH dose taken prior to the study.
Other Names:
  • Somatropin
  • rhGH

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
Percentage of participants with adverse events
Time Frame: 48 weeks
Safety of TV-1106 compared to reference drug
48 weeks

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
Time Frame
Change from baseline in Insulin-like Growth Factor 1 Standard Deviation Score
Time Frame: Baseline, Weeks: 4, 8, 12, 16, 24, 36, 48
Baseline, Weeks: 4, 8, 12, 16, 24, 36, 48

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.
February 29, 2016

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.
April 30, 2016

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.
December 10, 2021

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.
December 8, 2021

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.
December 1, 2021

More Information

Terms related to this study

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-30022

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.

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