Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Recombinant human growth hormone

+ TV-1106

Drug
Who is being recruted

Bone Diseases+10

+ Bone Diseases, Developmental

+ Bone Diseases, Endocrine

From 23 to 65 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorTeva Branded Pharmaceutical Products R&D, Inc.
Last updated: December 10, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: March 31, 2013

Actual date on which the first participant was enrolled.

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

NCT01811576
Principal SponsorTeva Branded Pharmaceutical Products R&D, Inc.
Last updated: December 10, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

52 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 23 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone DiseasesBone Diseases, DevelopmentalBone Diseases, EndocrineBrain DiseasesCentral Nervous System DiseasesDwarfismEndocrine System DiseasesHypopituitarismHypothalamic DiseasesMusculoskeletal DiseasesNervous System DiseasesPituitary DiseasesDwarfism, Pituitary

Criteria

5 inclusion criteria required to participate
Diagnosis of GH deficiency must be confirmed by documented (medical records) diagnostic testing
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
Other criteria apply
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
Show More Criteria
7 exclusion criteria prevent from participating
Other criteria apply
Patients with evidence of pituitary adenoma or other intracranial tumor within 12 months of enrollment, which is on day 0 (baseline, Visit 3)
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 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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Daily subcutaneous dose

Group II

Experimental
Titration dose levels of TV-1106

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 23 locations

Teva Investigational Site 10564

Portland, United StatesOpen Teva Investigational Site 10564 in Google Maps

Teva Investigational Site 54052

Hradec Králové, Czechia

Teva Investigational Site 54051

Olomouc, Czechia

Teva Investigational Site 32239

Dresden, Germany
Completed23 Study Centers