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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01811576
First received: March 12, 2013
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Growth Hormone Deficiency
Drug: TV-1106
Drug: Recombinant human growth hormone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Insulin-like growth factor I (IGF-I) concentration change from baseline [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients treated with TV1106 who return to pre-treatment IGF-1 SDS [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Safety Parameters [ Time Frame: 78 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 50
Study Start Date: March 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TV-1106
Titration dose levels of TV-1106
Drug: TV-1106
Active Comparator: recombinant human growth hormone
Daily subcutaneous dose
Drug: Recombinant human growth hormone
Subcutaneous once daily

  Eligibility

Ages Eligible for Study:   23 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01811576

Locations
United States, Oregon
Teva Investigational Site 10564
Portland, Oregon, United States
Czech Republic
Teva Investigational Site 54052
Hradec Kralove, Czech Republic
Teva Investigational Site 54051
Olomouc, Czech Republic
Germany
Teva Investigational Site 32239
Dresden, Germany
Teva Investigational Site 32238
Munich, Germany
Teva Investigational Site 32237
Munich, Germany
Greece
Teva Investigational Site 63044
Athens, Greece
Teva Investigational Site 63045
Athens, Greece
Hungary
Teva Investigational Site 51056
Budapest, Hungary
Teva Investigational Site 51055
Budapest, Hungary
Teva Investigational Site 51060
Debrecen, Hungary
Teva Investigational Site 51061
Gyor, Hungary
Teva Investigational Site 51059
Pecs, Hungary
Teva Investigational Site 51057
Szeged, Hungary
Teva Investigational Site 51058
Szolnok, Hungary
Israel
Teva Investigational Site 80033
Jerusalem, Israel
Teva Investigational Site 80032
Petach Tikva, Israel
Teva Investigational Site 80034
Tel Aviv, Israel
Serbia
Teva Investigational Site 61029
Belgrade, Serbia
Slovakia
Teva Investigational Site 62017
Bratislava, Slovakia
Teva Investigational Site 62022
Bratislava, Slovakia
Teva Investigational Site 62016
Lubochna, Slovakia
Slovenia
Teva Investigational Site 64016
Ljubljana, Slovenia
Sponsors and Collaborators
Teva Pharmaceutical Industries
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01811576     History of Changes
Other Study ID Numbers: TV1106-GHD-201
Study First Received: March 12, 2013
Last Updated: June 20, 2014
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Germany: Ministry of Health
Hungary: Ministry of Health, Social and Family Affairs
Israel: Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Slovakia: State Institute for Drug Control
Slovenia: Ministry of Health
Sweden: The National Board of Health and Welfare

Keywords provided by Teva Pharmaceutical Industries:
Growth hormone deficiency
Insulin-like growth factor I (IGF-I)
TV-1106

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Dwarfism
Hypopituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014