A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children

November 5, 2021 updated by: Teva Pharmaceutical Industries, Ltd.

A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children

The purpose of this study is to support selection of an appropriate safe and efficacious dose for study in further development.

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.
65

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 2

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

  • Belarus
      • Minsk, Belarus
        • Teva Investigational Site 68016
  • Bulgaria
      • Varna, Bulgaria
        • Teva Investigational Site 59060
  • Georgia
      • Tbilisi, Georgia
        • Teva Investigational Site 81022
      • Tbilisi, Georgia
        • Teva Investigational Site 81023
      • Tbilisi, Georgia
        • Teva Investigational Site 81025
  • Greece
      • Athens, Greece
        • Teva Investigational Site 63046
  • Hungary
      • Budapest, Hungary
        • Teva Investigational Site 51159
      • Budapest, Hungary
        • Teva Investigational Site 51160
      • Szombathely, Hungary
        • Teva Investigational Site 51181
  • Israel
      • Afula, Israel
        • Teva Investigational Site 80052
      • Beer Sheva, Israel
        • Teva Investigational Site 80055
      • Petach Tikva, Israel
        • Teva Investigational Site 80053
      • Ramat Gan, Israel
        • Teva Investigational Site 80056
  • Poland
      • Warszawa, Poland
        • Teva Investigational Site 53216
  • Romania
      • Timisoara, Romania
        • Teva Investigational Site 52056
  • Russian Federation
      • Izhevsk, Russian Federation
        • Teva Investigational Site 50261
      • Kazan, Russian Federation
        • Teva Investigational Site 50260
      • Moscow, Russian Federation
        • Teva Investigational Site 50258
      • Moscow, Russian Federation
        • Teva Investigational Site 50259
      • Novosibirsk, Russian Federation
        • Teva Investigational Site 50264
      • Saint-Petersburg, Russian Federation
        • Teva Investigational Site 50267
      • Samara, Russian Federation
        • Teva Investigational Site 50268
      • Saratov, Russian Federation
        • Teva Investigational Site 50263
      • Tomsk, Russian Federation
        • Teva Investigational Site 50262
      • Ufa, Russian Federation
        • Teva Investigational Site 50265
  • Serbia
      • Belgrade, Serbia
        • Teva Investigational Site 61030
      • Nis, Serbia
        • Teva Investigational Site 61032
  • Spain
      • Girona, Spain
        • Teva Investigational Site 31099
  • Turkey
      • Ankara, Turkey
        • Teva Investigational Site 82011
      • Aydın, Turkey
        • Teva Investigational Site 82013
  • Ukraine
      • Kharkiv, Ukraine
        • Teva Investigational Site 58138
      • Kiev, Ukraine
        • Teva Investigational Site 58140
      • Kyiv, Ukraine
        • Teva Investigational Site 58139
      • Odessa, Ukraine
        • Teva Investigational Site 58142

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

3 years to 11 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Criteria for Inclusion:

  • Pre-pubertal boys ≥ 3 years to ≤ 11 years and pre-pubertal girls ≥ 3 years to ≤ 10 years growth hormone (GH) insufficiency
  • Diagnosis criteria consistent with growth hormone research society consensus guidelines
  • Patients with a previously treated pituitary tumor must have no tumor progression for at least the past year
  • Physician determined rate of change in height less than 2 standard deviations per age group.
  • Written Informed Consent
  • Parent or legal guardian who is capable and willing to administer the study drug.
  • Other criteria apply, please contact the investigator for more information

Criteria for Exclusion:

  • Any clinically significant medical condition as determined by the investigator, that is likely to affect growth
  • Contraindications to rhGH treatment;
  • History of or currently active malignancy, including pituitary tumors;
  • Bone age, greater than chronological age or greater than 9 for girls or greater than 10 for boys within 3 months of screening.
  • Patients with known diagnosis of diabetes or pre-diabetes
  • Growth altering medications
  • Allergies to the study medication components;
  • Participation in another investigational study within 30 days of screening
  • Any medical condition as judged by the investigator to interfere with patient participation or the objectives of the study
  • 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
  • Masking: NONE

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 0.554 mg
Drug: TV-1106
TV-1106 0.554mg, TV-1106 0.924 mg, TV-1106 1.20 mg
Other Names:
  • albutropin
  • Human Growth Hormone Therapy
EXPERIMENTAL: TV-1106 0.924 mg/kg
Drug: TV-1106
TV-1106 0.554mg, TV-1106 0.924 mg, TV-1106 1.20 mg
Other Names:
  • albutropin
  • Human Growth Hormone Therapy
EXPERIMENTAL: TV-1106 1.20 mg/kg
Drug: TV-1106
TV-1106 0.554mg, TV-1106 0.924 mg, TV-1106 1.20 mg
Other Names:
  • albutropin
  • Human Growth Hormone Therapy
ACTIVE_COMPARATOR: somatropin 0.033 mg/kg/day
Dosages may be adjusted according to findings and as necessary
Drug: somatropin
Dose may be adjusted as required
Other Names:
  • Human Growth Hormone Therapy

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
Time Frame
Height velocity (HV)
Time Frame: Month 6
Month 6

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
Height velocity standard deviation score (HV-SDS)
Time Frame: Months 6 and 12
Months 6 and 12
Height standard deviation score (H-SDS)
Time Frame: Months 6 and 12
Months 6 and 12
Number of participants with adverse events
Time Frame: up to 24 months
up to 24 months
Height velocity (HV)
Time Frame: Month 12
Month 12

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 Pharmaceutical Industries, Ltd.

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, 2014

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.
April 30, 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.
August 31, 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 14, 2014

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.
March 17, 2014

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.
March 19, 2014

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.
November 9, 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.
November 5, 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.
November 1, 2021

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-20001
  • 2013-004468-69 (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.

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