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

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • 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

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
Intervention / Treatment
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

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

Secondary Outcome Measures

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

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)

April 30, 2014

Primary Completion (ACTUAL)

April 30, 2016

Study Completion (ACTUAL)

August 31, 2016

Study Registration Dates

First Submitted

March 14, 2014

First Submitted That Met QC Criteria

March 17, 2014

First Posted (ESTIMATE)

March 19, 2014

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Growth Hormone-Deficiency

Clinical Trials on TV-1106

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe