Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency

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

A 64-Week (12-week Core Phase and 52-week Safety Extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency

The primary objective of this study is to evaluate the clinical effect of TV-1106.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

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

  • Czechia
      • Hradec Kralove, Czechia, 500 05
        • Teva Investigational Site 54052
      • Olomouc, Czechia, 775 20
        • Teva Investigational Site 54051
  • Germany
      • Dresden, Germany, 01307
        • Teva Investigational Site 32239
      • Munich, Germany, 80336
        • Teva Investigational Site 32238
      • Munich, Germany, 80804
        • Teva Investigational Site 32237
  • Greece
      • Athens, Greece, 10676
        • Teva Investigational Site 63044
      • Athens, Greece, 11527
        • Teva Investigational Site 63045
  • Hungary
      • Budapest, Hungary, 1062
        • Teva Investigational Site 51056
      • Budapest, Hungary, 1088
        • Teva Investigational Site 51055
      • Debrecen, Hungary, 4012
        • Teva Investigational Site 51060
      • Gyor, Hungary, H-9023
        • Teva Investigational Site 51061
      • Pecs, Hungary, 7624
        • Teva Investigational Site 51059
      • Szeged, Hungary, H-6720
        • Teva Investigational Site 51057
      • Szolnok, Hungary, 5000
        • Teva Investigational Site 51058
  • Israel
      • Jerusalem, Israel, 91120
        • Teva Investigational Site 80033
      • Petach Tikva, Israel, 49100
        • Teva Investigational Site 80032
      • Tel Aviv, Israel, 78278
        • Teva Investigational Site 80034
  • Serbia
      • Belgrade, Serbia, 11 000
        • Teva Investigational Site 61029
  • Slovakia
      • Bratislava, Slovakia, 826 06
        • Teva Investigational Site 62017
      • Bratislava, Slovakia, 833 05
        • Teva Investigational Site 62022
      • Lubochna, Slovakia, 034 91
        • Teva Investigational Site 62016
  • Slovenia
      • Ljubljana, Slovenia, 1525
        • Teva Investigational Site 64016
  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Teva Investigational Site 10564

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

23 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient agrees to provide written informed consent and to comply with the study protocol after reading the informed consent and discussing the study with the investigator.
  • Males and females between 23 and 65 years of age must have a confirmed diagnosis of adult GHD, either adult onset (AO) GHD due to hypothalamic-pituitary disease or childhood onset (CO) GHD that is either idiopathic or due to hypothalamic-pituitary disease or due to genetic causes.
  • Diagnosis of GH deficiency must be confirmed by documented (medical records) diagnostic testing.
  • Patients should have been treated with a stable dose of daily rhGH for at least 3 months prior to screening.
  • Other criteria apply.

Exclusion Criteria:

  • Patients with history or clinical evidence of active or chronic diseases that could confound results of the study or put the subject at undue risk as determined by the investigator.
  • Patients with known active malignancy
  • Patients with history of malignancy other than intracranial tumor causing GHD (excluding surgically cured basal cell or squamous cell cancer of the skin with documented 6 month remission)
  • Patients with evidence of pituitary adenoma or other intracranial tumor within 12 months of enrollment, which is on day 0 (baseline, Visit 3)
  • Patients without magnetic resonance imaging (MRI) or computerized tomography (CT) data to document tumor stability within the 12 months prior to enrollment, which is on day 0 (baseline, Visit 3)
  • 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.
  • Other criteria apply.

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
Intervention / Treatment
Active Comparator: recombinant human growth hormone
Daily subcutaneous dose
Drug: Recombinant human growth hormone
Subcutaneous once daily
Experimental: TV-1106
Titration dose levels of TV-1106
Drug: TV-1106

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Insulin-like growth factor I (IGF-I) concentration change from baseline
Time Frame: Baseline to Week 12
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients treated with TV1106 who return to pre-treatment IGF-1 SDS
Time Frame: Baseline to Week 12
Baseline to Week 12
Safety Parameters
Time Frame: 78 weeks
The safety of TV-1106 will be assessed throughout the study by evaluating adverse events,concomitant medication usage, physical examinations including urinalysis and body weight, vital sign measurements, clinical laboratory test results and hormone levels, electrocardiograms (ECGs), and immunogenicity.
78 weeks

Collaborators and Investigators

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

Sponsor

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)

March 31, 2013

Primary Completion (Actual)

August 5, 2013

Study Completion (Actual)

August 5, 2013

Study Registration Dates

First Submitted

March 12, 2013

First Submitted That Met QC Criteria

March 12, 2013

First Posted (Estimate)

March 14, 2013

Study Record Updates

Last Update Posted (Actual)

December 10, 2021

Last Update Submitted That Met QC Criteria

December 8, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TV1106-GHD-201
  • 2012-004975-37 (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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