Growth Hormone DeficiencyPhase 2NCT01811576
Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency
A Phase 2 study testing TV-1106 and Recombinant human growth hormone in people with Growth Hormone Deficiency, run by Teva Branded Pharmaceutical Products R&D, Inc. at 23 sites in 9 countries.
Trial summary
The primary objective of this study is to evaluate the clinical effect of TV-1106. Read more about this study
- Who is it for?
- Ages 23 to 65 years
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- TV-1106 and Recombinant human growth hormone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 23 sitesin 9 countries
- Study dates
- 31 Mar 2013to 5 Aug 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
23 sites in 9 countries.
23 sites in 9 countries
Hungary7 sites
Teva Investigational Site 51056
Budapest, 1062
Teva Investigational Site 51055
Budapest, 1088
Teva Investigational Site 51060
Debrecen, 4012
Teva Investigational Site 51061
Győr, H-9023
Teva Investigational Site 51059
Pécs, 7624
Teva Investigational Site 51057
Szeged, H-6720
Teva Investigational Site 51058
Szolnok, 5000
Germany3 sites
Teva Investigational Site 32239
Dresden, 01307
Teva Investigational Site 32238
Munich, 80336
Teva Investigational Site 32237
Munich, 80804
Israel3 sites
Teva Investigational Site 80033
Jerusalem, 91120
Teva Investigational Site 80032
Petah Tikva, 49100
Teva Investigational Site 80034
Tel Aviv, 78278
Slovakia3 sites
Teva Investigational Site 62017
Bratislava, 826 06
Teva Investigational Site 62022
Bratislava, 833 05
Teva Investigational Site 62016
Ľubochňa, 034 91
Czechia2 sites
Teva Investigational Site 54052
Hradec Králové, 500 05
Teva Investigational Site 54051
Olomouc, 775 20
Greece2 sites
Teva Investigational Site 63044
Athens, 10676
Teva Investigational Site 63045
Athens, 11527
United States1 site
Teva Investigational Site 10564
Portland, Oregon, 97239
About this study
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
The primary objective of this study is to evaluate the clinical effect of TV-1106.
- Conditions
- Growth Hormone Deficiency
- Being tested
- TV-1106, Recombinant human growth hormone
- Keywords
- Growth hormone deficiency, Insulin-like growth factor I (IGF-I), TV-1106
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TV-1106Drug
Recombinant human growth hormoneDrug
Subcutaneous once daily
| Study group | Role | What they receive |
|---|---|---|
| recombinant human growth hormone | Active comparator | Daily subcutaneous dose Receives: Drug: Recombinant human growth hormone |
| TV-1106 | Experimental | Titration dose levels of TV-1106 Receives: Drug: TV-1106 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin-like growth factor I (IGF-I) concentration change from baseline
Measured: Baseline to Week 12
Secondary outcomes (2)
Percentage of patients treated with TV1106 who return to pre-treatment IGF-1 SDS
Measured: Baseline to Week 12
Safety Parameters
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.
Measured: 78 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study start31 Mar 2013
- Primary completion5 Aug 2013
- Study completion5 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811576
- Sponsor's protocol ID
- TV1106-GHD-201
- Other IDs
- 2012-004975-37
- Status last verified
- Dec 2021
- First submitted
- 12 Mar 2013
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01811576
- Acronym / sponsor ID
- TV1106-GHD-201
- Conditions
- Growth Hormone Deficiency
- Keywords
- Growth hormone deficiency, Insulin-like growth factor I (IGF-I), TV-1106
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2013 (actual)
- Primary completion
- 5 Aug 2013 (actual)
- Study completion
- 5 Aug 2013 (actual)
- First posted
- 14 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the clinical effect of TV-1106.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| recombinant human growth hormone | Active comparator | Drug: Recombinant human growth hormoneDaily subcutaneous dose |
| TV-1106 | Experimental | Drug: TV-1106Titration dose levels of TV-1106 |
Who may qualify
- Ages
- 23 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TV-1106 | Drug | TV-1106 |
| Recombinant human growth hormoneSubcutaneous once daily | Drug | recombinant human growth hormone |
Primary outcome
Insulin-like growth factor I (IGF-I) concentration change from baseline
Time frame: Baseline to Week 12
2 secondary outcomes
Percentage of patients treated with TV1106 who return to pre-treatment IGF-1 SDS
Time frame: Baseline to Week 12
Safety Parameters
Time frame: 78 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TV-1106 and Recombinant human growth hormone in people with Growth Hormone Deficiency, run by Teva Branded Pharmaceutical Products R&D, Inc. at 23 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Hungary, Germany, Israel, Slovakia, Czechia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin-like growth factor I (IGF-I) concentration change from baseline (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.