Growth Hormone-DeficiencyPhase 2NCT02092077
A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children
A Phase 2 study testing TV-1106 and somatropin in people with Growth Hormone-Deficiency, run by Teva Pharmaceutical Industries, Ltd. at 34 sites in 13 countries.
Trial summary
The purpose of this study is to support selection of an appropriate safe and efficacious dose for study in further development. Read more about this study
- Who is it for?
- Ages 3 to 11 years
- Conditions the study is for
- Growth Hormone-Deficiency
- What is being tested?
- TV-1106 and somatropin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 34 sitesin 13 countries
- Study dates
- 30 Apr 2014to 31 Aug 2016
- 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 3 to 11 years
- All sexes
- No healthy volunteers
- Child
Criteria for Inclusion:
- Pre-pubertal boys ≥ 3 years to ≤ 11 years and pre-pubertal girls ≥ 3 years to ≤ 10 years growth hormone (GH) insufficiency
- Diagnosis criteria consistent with growth hormone research society consensus guidelines
- Patients with a previously treated pituitary tumor must have no tumor progression for at least the past year
- Physician determined rate of change in height less than 2 standard deviations per age group.
- Written Informed Consent
- Parent or legal guardian who is capable and willing to administer the study drug.
- Other criteria apply, please contact the investigator for more information
Criteria for Exclusion:
- Any clinically significant medical condition as determined by the investigator, that is likely to affect growth
- Contraindications to rhGH treatment;
- History of or currently active malignancy, including pituitary tumors;
- Bone age, greater than chronological age or greater than 9 for girls or greater than 10 for boys within 3 months of screening.
- Patients with known diagnosis of diabetes or pre-diabetes
- Growth altering medications
- Allergies to the study medication components;
- Participation in another investigational study within 30 days of screening
- Any medical condition as judged by the investigator to interfere with patient participation or the objectives of the study
- Other criteria apply, please contact the investigator for more information
Trial locations and contacts
34 sites in 13 countries.
34 sites in 13 countries
Russia10 sites
Teva Investigational Site 50261
Izhevsk
Teva Investigational Site 50260
Kazan'
Teva Investigational Site 50258
Moscow
Teva Investigational Site 50259
Moscow
Teva Investigational Site 50264
Novosibirsk
Teva Investigational Site 50267
Saint Petersburg
Teva Investigational Site 50268
Samara
Teva Investigational Site 50263
Saratov
Teva Investigational Site 50262
Tomsk
Teva Investigational Site 50265
Ufa
Israel4 sites
Teva Investigational Site 80052
Afula
Teva Investigational Site 80055
Beersheba
Teva Investigational Site 80053
Petah Tikva
Teva Investigational Site 80056
Ramat Gan
Ukraine4 sites
Teva Investigational Site 58138
Kharkiv
Teva Investigational Site 58140
Kiev
Teva Investigational Site 58139
Kyiv
Teva Investigational Site 58142
Odesa
Georgia3 sites
Teva Investigational Site 81022
Tbilisi
Teva Investigational Site 81023
Tbilisi
Teva Investigational Site 81025
Tbilisi
Hungary3 sites
Teva Investigational Site 51159
Budapest
Teva Investigational Site 51160
Budapest
Teva Investigational Site 51181
Szombathely
Serbia2 sites
Teva Investigational Site 61030
Belgrade
Teva Investigational Site 61032
Niš
Turkey (Türkiye)2 sites
Teva Investigational Site 82011
Ankara
Teva Investigational Site 82013
Aydin
About this study
Official title: A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children
The purpose of this study is to support selection of an appropriate safe and efficacious dose for study in further development.
- Conditions
- Growth Hormone-Deficiency
- Being tested
- TV-1106, somatropin
- Keywords
- Growth Hormone-Deficient, recombinant human growth hormone
- 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
Also called albutropin, Human Growth Hormone Therapy
TV-1106 0.554mg, TV-1106 0.924 mg, TV-1106 1.20 mg
somatropinDrug
Also called Human Growth Hormone Therapy
Dose may be adjusted as required
| Study group | Role | What they receive |
|---|---|---|
| TV-1106 0.554 mg | Experimental | Not described Receives: Drug: TV-1106 |
| TV-1106 0.924 mg/kg | Experimental | Not described Receives: Drug: TV-1106 |
| TV-1106 1.20 mg/kg | Experimental | Not described Receives: Drug: TV-1106 |
| somatropin 0.033 mg/kg/day | Active comparator | Dosages may be adjusted according to findings and as necessary Receives: Drug: somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height velocity (HV)
Measured: Month 6
Secondary outcomes (4)
Height velocity standard deviation score (HV-SDS)
Measured: Months 6 and 12
Height standard deviation score (H-SDS)
Measured: Months 6 and 12
Number of participants with adverse events
Measured: up to 24 months
Height velocity (HV)
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study start30 Apr 2014
- Primary completion30 Apr 2016
- Study completion31 Aug 2016
Why it stopped: Business decision
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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceutical Industries, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092077
- Sponsor's protocol ID
- TV1106-IMM-20001
- Other IDs
- 2013-004468-69
- Status last verified
- Nov 2021
- First submitted
- 14 Mar 2014
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children
- ClinicalTrials.gov ID
- NCT02092077
- Acronym / sponsor ID
- TV1106-IMM-20001
- Conditions
- Growth Hormone-Deficiency
- Keywords
- Growth Hormone-Deficient, recombinant human growth hormone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Teva Pharmaceutical Industries, Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2014 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 19 Mar 2014 (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 purpose of this study is to support selection of an appropriate safe and efficacious dose for study in further development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TV-1106 0.554 mg | Experimental | Drug: TV-1106 |
| TV-1106 0.924 mg/kg | Experimental | Drug: TV-1106 |
| TV-1106 1.20 mg/kg | Experimental | Drug: TV-1106 |
| somatropin 0.033 mg/kg/day | Active comparator | Drug: somatropinDosages may be adjusted according to findings and as necessary |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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-1106Also: albutropin, Human Growth Hormone TherapyTV-1106 0.554mg, TV-1106 0.924 mg, TV-1106 1.20 mg | Drug | TV-1106 0.554 mg, TV-1106 0.924 mg/kg, TV-1106 1.20 mg/kg |
| somatropinAlso: Human Growth Hormone TherapyDose may be adjusted as required | Drug | somatropin 0.033 mg/kg/day |
Primary outcome
Height velocity (HV)
Time frame: Month 6
4 secondary outcomes
Height velocity standard deviation score (HV-SDS)
Time frame: Months 6 and 12
Height standard deviation score (H-SDS)
Time frame: Months 6 and 12
Number of participants with adverse events
Time frame: up to 24 months
Height velocity (HV)
Time frame: Month 12
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
Related trials for Growth Hormone-Deficiency
RecruitingPhase 3
Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
Growth Disorders, Growth Failure
RecruitingPhase 3
Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
Growth Hormone Deficiency (GHD)
RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury
Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
Active, not recruitingObservational study
Ngenla Subcutaneous Injection Special Investigation
Growth Hormone Deficiency Without Epiphyseal Closure
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.
Medical Director, MD study director
Teva Branded Pharmaceutical Products R&D, Inc.
34 sites in 13 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 somatropin in people with Growth Hormone-Deficiency, run by Teva Pharmaceutical Industries, Ltd. at 34 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Russia, Israel, Ukraine, Georgia, Hungary and 8 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 was stopped early (reason given: Business decision). Results are not available in the source record.
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?
Height velocity (HV) (time frame: Month 6). 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 9 Nov 2021.