Growth Hormone DeficiencyPhase 3NCT02410343
Study of TV-1106 in Growth Hormone-Deficient Adults
A Phase 3 study testing TV-1106 in people with Growth Hormone Deficiency, run by Teva Branded Pharmaceutical Products R&D, Inc. at 33 sites in 7 countries.
Trial summary
The primary objective of this study is to determine the efficacy of 6 months of treatment with TV-1106 compared with placebo on body fat composition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- TV-1106
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 33 sitesin 7 countries
- Study dates
- 30 Apr 2015to 31 Dec 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- males and females 18 years of age or over
- diagnosis of adult growth hormone deficiency (GHD) for at least 6 months, or patients who have hypopituitarism from surgical resection
- no history of exposure to any rhGH within the past 12 months prior to screening
- stable, adequate doses of replacement hormones (adrenal, thyroid, estrogen, testosterone, vasopressin) for at least 3 months prior to screening
- Other criteria apply, please contact the investigator for more information
Who cannot join
- patients with acute or chronic conditions or diseases that could confound results of the study or put the patient at undue risk as determined by the investigator
- Presence of contraindications to rhGH treatment
- patients who have participated in another clinical trial with a new chemical/biological entity within 3 months of screening
- patients with known active malignancy (excluding surgically removed basal cell carcinoma or carcinoma in situ of cervix)
- patients with a previously treated pituitary tumor with evidence of tumor progression in the past year patients with a new diagnosis of pituitary adenoma or other intracranial tumor within 12 months of screening
- 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
Show all 10Show fewer
- patients with type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus as indicated by a glycated hemoglobin (HBA1c) of ≥8%
- patients using weight reducing agents or appetite suppressants
- women who are pregnant or nursing, or planning pregnancy during the study period
- Other criteria apply, please contact the investigator for more information
Trial locations and contacts
33 sites in 7 countries.
33 sites in 7 countries
United States25 sites
Teva Investigational Site 13110
Arlington, Texas, 76014
Teva Investigational Site 13102
Artesia, California, 90701
Teva Investigational Site 13096
Asheville, North Carolina, 28803
Teva Investigational Site 13109
Brooklyn, New York, 11235
Teva Investigational Site 13104
Chicago, Illinois, 60612
Teva Investigational Site 13125
Dallas, Texas, 75218
Teva Investigational Site 13101
Detroit, Michigan, 48202
Teva Investigational Site 13124
Evansville, Indiana, 47714
Teva Investigational Site 13127
Fountain Valley, California, 33155-6541
Teva Investigational Site 13126
Fountain Valley, California, 92708
Teva Investigational Site 13112
Henderson, Nevada, 89052
Teva Investigational Site 13097
Houston, Texas, 77079
Teva Investigational Site 13107
Houston, Texas, 77084
Teva Investigational Site 13120
Houston, Texas, 77090
Teva Investigational Site 13113
Las Vegas, Nevada, 89148
Teva Investigational Site 13103
Miami, Florida, 33126
Teva Investigational Site 13118
Miami, Florida, 33130
Teva Investigational Site 13123
Miami, Florida, 33145
Teva Investigational Site 13492
Miami, Florida, 33155-6541
Teva Investigational Site 13114
Miami Lakes, Florida, 33016
Teva Investigational Site 13494
New York, New York, 10016
Teva Investigational Site 13106
New York, New York, 10032
Teva Investigational Site 13100
Pembroke Pines, Florida, 33024
Teva Investigational Site 13108
Pittsburgh, Pennsylvania, 15212
Teva Investigational Site 13121
West Palm Beach, Florida, 33401
Greece2 sites
Teva Investigational Site 63054
Athens, 11527
Teva Investigational Site 63053
Chaïdári, 12462
Hungary2 sites
Teva Investigational Site 51197
Budapest, 1088
Teva Investigational Site 51195
Pécs, 7624
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy, Safety and Tolerability Study of TV-1106 in Growth Hormone-Deficient Adults Who Are Not Current Users of rhGH Treatment
The primary objective of this study is to determine the efficacy of 6 months of treatment with TV-1106 compared with placebo on body fat composition.
- Conditions
- Growth Hormone Deficiency
- Being tested
- TV-1106, Placebo
- Keywords
- long acting 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 long-acting growth hormone, albutropin
A starting dose of 5.0 mg was expected to be appropriate for most patients because the daily recommended starting dose of recombinant human growth hormone (rhGH) treatments (e.g. somatropin) is 0.2 mg/day, and the conversion factor was 28. Dosage could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 until the participant's insulin-like growth factor 1 (IGF-1) standard deviation score (SDS) was within the range of -0.5 to +1.5.
PlaceboDrug
Also called Matching placebo
Placebo treatment was administered in a blinded fashion and titrated on weeks 4, 8, 12 and 16 to mimic the active treatment.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo was injected subcutaneously once weekly on the same day and time for 24 weeks. To maintain the blind, placebo could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 to match the effect of dose titration. Receives: Drug: Placebo |
| TV-1106 | Experimental | TV-1106 was injected subcutaneously once weekly on the same day and time for 24 weeks. A common starting dose was 5.0 mg. Doses could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 until the participant's insulin-like growth factor 1 (IGF-1) standard deviation score (SDS) was within the range of -0.5 to +1.5. Receives: Drug: TV-1106 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Fat Mass at Baseline, Week 24 and Endpoint in Core Period
The primary efficacy measure for the study was body fat mass (kg) measured by DXA imaging. The primary outcome as defined in the protocol was the change from baseline to week 24 in body fat mass. Due to the early termination of the study, observed values including endpoint values are reported. Endpoint is the last observed value.
Measured: Baseline (Day 1, pre-dose), Week 24, Endpoint in Core period
Secondary outcomes (14)
Total Trunk Fat at Baseline, Week 24 and Endpoint in Core Period
Trunk fat (kg) was assessed based on DXA results. Trunk fat was defined as fat mass - (total arm fat + total leg fat + total head fat). The outcome as defined in the protocol was the within-patient change from baseline to week 24 in trunk fat. Due to the early termination of the study, observed values including endpoint values are reported. Endpoint is the last observed value.
Measured: Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period
Insulin-Like Growth Factor 1 Standard Deviation Score (IGF-I SDS) at Baseline, Week 24 and Endpoint in Core Period
IGF-I SDS, as reported by the central laboratory, was a key secondary variable. The week 24 value is a trough value as it was taken 7 days after the last TV-1106 or placebo injection. The outcome as defined in the protocol was the within-patient change from baseline to week 24. Due to the early termination of the study, observed values including endpoint values are reported. Endpoint is the last observed value and is of variable length of time since last TV-1106 or placebo injection.
Measured: Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period
Scored Analysis of Quality of Life Assessment of GH Deficiency in Adults (QoL-AGHDA) at Baseline, Week 24 and Endpoint in Core Period
The AGHDA instrument is comprised of 25 questions, with yes or no answers. To each of the 25 questions comprising QOL AGHDA, a score of 1 was assigned if the answer was affirmative and 0 if the answer was negative. Data reported is the total score across the 25 questions for a total range of 0-25 with higher scores representing a poorer quality of life. The outcome as defined in the protocol was the within-patient change from baseline to week 24. Due to the early termination of the study, observed values including endpoint values are reported. Endpoint is the last observed value.
Measured: Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period
Participants With Adverse Events During the Core Period
An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents usual activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Measured: Day 1 up to 24 Weeks
Participants With Potentially Clinically Significant Abnormal Blood and Urine Test Results
Parameters with potentially clinically significant abnormal test results include - Serum chemistry: blood urea nitrogen, creatinine and bilirubin - Hematology: leukocytes, hemoglobin, hematocrit, platelets and neutrophils - Urinalysis: none Significance criteria are listed below with the test.
Measured: Day 1 up to 24 Weeks
Shift From Baseline To Endpoint in Core Period in Electrocardiogram Findings
Shifts represented as baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicates an abnormal but not clinically significant finding. Abnormal CS indicates an abnormal and clinically significant finding.
Measured: Day 1 up to Week 24
Thyroid Stimulating Hormone (TSH) at Baseline and Endpoint
One measure of changes in replacement hormones.
Measured: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Free Thyroxin (Free T4) at Baseline and Endpoint
One measure of changes in replacement hormones.
Measured: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Triiodothyronine (Total T3) at Baseline and Endpoint
One measure of changes in replacement hormones.
Measured: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Glycated Hemoglobin (HbA1c) at Baseline and Endpoint
One measure of glucose homeostasis.
Measured: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Fasting Blood Glucose at Baseline and Endpoint
One measure of glucose homeostasis.
Measured: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Insulin at Baseline and Endpoint
One measure of glucose homeostasis.
Measured: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Local Tolerability Assessed by Injection Site Reactions
Participants reporting at least one injection site reaction.
Measured: Daay 1 up to Week 24
Pharmacokinetic Serum Concentration of TV1106 by Nominal Sampling Timepoints
Weeks 4 and 8 serum samples obtained 2 days after TV1106 administration. Weeks 12 and 24 serum samples obtained 7 days after TV1106 administration. Week 16 serum samples obtained 1 day after TV1106 administration.
Measured: Baseline (Day 1, pre-dose), Weeks 4, 8, 12, 16, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study start30 Apr 2015
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410343
- Sponsor's protocol ID
- TV1106-IMM-30021
- Other IDs
- 2014-003796-32, 2014
- Status last verified
- Jan 2022
- First submitted
- 30 Mar 2015
- Last updated
- 24 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy, Safety and Tolerability Study of TV-1106 in Growth Hormone-Deficient Adults Who Are Not Current Users of rhGH Treatment
- ClinicalTrials.gov ID
- NCT02410343
- Acronym / sponsor ID
- TV1106-IMM-30021
- Conditions
- Growth Hormone Deficiency
- Keywords
- long acting growth hormone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2015 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Posted 11 Jun 2018
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 determine the efficacy of 6 months of treatment with TV-1106 compared with placebo on body fat composition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo was injected subcutaneously once weekly on the same day and time for 24 weeks. To maintain the blind, placebo could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 to match the effect of dose titration. |
| TV-1106 | Experimental | Drug: TV-1106TV-1106 was injected subcutaneously once weekly on the same day and time for 24 weeks. A common starting dose was 5.0 mg. Doses could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 until the participant's insulin-like growth factor 1 (IGF-1) standard deviation score (SDS) was within the range of -0.5 to +1.5. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- males and females 18 years of age or over
- diagnosis of adult growth hormone deficiency (GHD) for at least 6 months, or patients who have hypopituitarism from surgical resection
- no history of exposure to any rhGH within the past 12 months prior to screening
- stable, adequate doses of replacement hormones (adrenal, thyroid, estrogen, testosterone, vasopressin) for at least 3 months prior to screening
Key exclusion criteria (10 listed)
- patients with acute or chronic conditions or diseases that could confound results of the study or put the patient at undue risk as determined by the investigator
- Presence of contraindications to rhGH treatment
- patients who have participated in another clinical trial with a new chemical/biological entity within 3 months of screening
- patients with known active malignancy (excluding surgically removed basal cell carcinoma or carcinoma in situ of cervix)
- patients with a previously treated pituitary tumor with evidence of tumor progression in the past year patients with a new diagnosis of pituitary adenoma or other intracranial tumor within 12 months of screening
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: long-acting growth hormone, albutropinA starting dose of 5.0 mg was expected to be appropriate for most patients because the daily recommended starting dose of recombinant human growth hormone (rhGH) treatments (e.g. somatropin) is 0.2 mg/day, and the conversion factor was 28. Dosage could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 until the participant's insulin-like growth factor 1 (IGF-1) standard deviation score (SDS) was within the range of -0.5 to +1.5. | Drug | TV-1106 |
| PlaceboAlso: Matching placeboPlacebo treatment was administered in a blinded fashion and titrated on weeks 4, 8, 12 and 16 to mimic the active treatment. | Drug | Placebo |
Primary outcome
Body Fat Mass at Baseline, Week 24 and Endpoint in Core Period
Time frame: Baseline (Day 1, pre-dose), Week 24, Endpoint in Core period
The primary efficacy measure for the study was body fat mass (kg) measured by DXA imaging. The primary outcome as defined in the protocol was the change from baseline to week 24 in body fat mass. Due to the early termination of the study, observed values including endpoint values are reported. Endpoint is the last observed value.
14 secondary outcomes
Total Trunk Fat at Baseline, Week 24 and Endpoint in Core Period
Time frame: Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period
Insulin-Like Growth Factor 1 Standard Deviation Score (IGF-I SDS) at Baseline, Week 24 and Endpoint in Core Period
Time frame: Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period
Scored Analysis of Quality of Life Assessment of GH Deficiency in Adults (QoL-AGHDA) at Baseline, Week 24 and Endpoint in Core Period
Time frame: Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period
Participants With Adverse Events During the Core Period
Time frame: Day 1 up to 24 Weeks
Participants With Potentially Clinically Significant Abnormal Blood and Urine Test Results
Time frame: Day 1 up to 24 Weeks
Shift From Baseline To Endpoint in Core Period in Electrocardiogram Findings
Time frame: Day 1 up to Week 24
Thyroid Stimulating Hormone (TSH) at Baseline and Endpoint
Time frame: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Free Thyroxin (Free T4) at Baseline and Endpoint
Time frame: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Triiodothyronine (Total T3) at Baseline and Endpoint
Time frame: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Glycated Hemoglobin (HbA1c) at Baseline and Endpoint
Time frame: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Fasting Blood Glucose at Baseline and Endpoint
Time frame: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Insulin at Baseline and Endpoint
Time frame: Baseline (Day 1, pre-dose), Endpoint (up to Week 24)
Local Tolerability Assessed by Injection Site Reactions
Time frame: Daay 1 up to Week 24
Pharmacokinetic Serum Concentration of TV1106 by Nominal Sampling Timepoints
Time frame: Baseline (Day 1, pre-dose), Weeks 4, 8, 12, 16, 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D, Inc.
33 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TV-1106 in people with Growth Hormone Deficiency, run by Teva Branded Pharmaceutical Products R&D, Inc. at 33 sites in 7 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 10 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: stopped early, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Greece, Hungary, Austria, Czechia and 2 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Body Fat Mass at Baseline, Week 24 and Endpoint in Core Period (time frame: Baseline (Day 1, pre-dose), Week 24, Endpoint in Core period). 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 24 Jan 2022.