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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 21 December 2021
Main ID:  NCT01811576
Date of registration: 12/03/2013
Prospective Registration: Yes
Primary sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Public 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
Scientific 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
Date of first enrolment: March 31, 2013
Target sample size: 52
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01811576
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
Czech Republic Czechia Germany Greece Hungary Israel Serbia Slovakia
Slovenia Sweden United States
Contacts
Key inclusion & exclusion 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.



Age minimum: 23 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Growth Hormone Deficiency
Intervention(s)
Drug: TV-1106
Drug: Recombinant human growth hormone
Primary Outcome(s)
Insulin-like growth factor I (IGF-I) concentration change from baseline [Time Frame: Baseline to Week 12]
Secondary Outcome(s)
Safety Parameters [Time Frame: 78 weeks]
Percentage of patients treated with TV1106 who return to pre-treatment IGF-1 SDS [Time Frame: Baseline to Week 12]
Secondary ID(s)
TV1106-GHD-201
2012-004975-37
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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