Clinical Trial Results:
A Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH
(GENOTROPIN®1) in Adults with Growth Hormone-Deficiency
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Summary
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EudraCT number |
2014-002736-13 |
Trial protocol |
DE HU SE IT AT ES SI LT GR CZ PL SK HR |
Global end of trial date |
18 Dec 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Dec 2016
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First version publication date |
26 Dec 2016
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
TV1106-IMM-30022
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02410356 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Teva Pharmaceutical Industries Ltd.
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Sponsor organisation address |
5 Bazel Street, Petach Tikva, Israel, 49131
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Public contact |
Director, Clinical Research, Teva Branded Pharmaceutical Products, R&D Inc., 001 215-591-3000, info-era-clinical@teva.de
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Scientific contact |
Director, Clinical Research, Teva Branded Pharmaceutical Products, R&D Inc., 001 215-591-3000, info-era-clinical@teva.de
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
19 Sep 2016
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
18 Dec 2015
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The primary objective of this study is to compare the safety and tolerability of weekly TV-1106 with daily Genotropin.
Based on evolving data from the two ongoing global Phase III studies in adults (TV1106-IMM-30021 and
-30022) and the ongoing pediatric Phase II study (TV1106-IMM-20001) and as well as the recently
completed adult Phase II study (TV1106-GHD-201), the Sponsor Teva Pharmaceuticals Ltd. reassessed
the benefit/risk balance of TV-1106 and the likelihood of regulatory success for TV-1106. As a
consequence of this reassessment, the Sponsor took the decision to terminate the development of TV-
1106 and stop all ongoing clinical trials. Notably, no new safety issues were identified with the
administration of TV-1106.
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Protection of trial subjects |
This study was conducted in full accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Consolidated Guideline (E6) and any applicable national and local laws and regulations (eg, Code of Federal Regulations Title 21, Parts 50, 54, 56, 312, and 314; EU Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of GCP in the conduct of clinical trials on medicinal products for human use).
Written and/or oral information about the study was provided to all patients in a language understandable by the patients. The information included an adequate explanation of the aims, methods, anticipated benefits, potential hazards, and insurance arrangements in force. Written informed consent was obtained from each patient before any study procedures or assessments were done. It was explained to the patients that they were free to refuse entry
into the study and free to withdraw from the study at any time without prejudice to future treatment.
Each patient’s willingness to participate in the study was documented in writing in a consent form that was signed by the patient with the date of that signature indicated. Each investigator kept the original consent forms, and copies were given to the patients.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Apr 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Hungary: 2
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Country: Number of subjects enrolled |
United States: 32
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Worldwide total number of subjects |
34
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EEA total number of subjects |
2
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
25
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From 65 to 84 years |
8
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85 years and over |
1
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Recruitment
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Recruitment details |
78 patients with GHD were screened for enrollment. 34 patients at 10 centers in the US and Hungary met entry criteria and were considered eligible for randomization. 44 patients who were not randomly assigned to study treatment: 18 were excluded due to inclusion/exclusion criteria and 26 were excluded for “other” reasons. | ||||||||||||||||||
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Pre-assignment
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Screening details |
Eligible patients were randomly assigned to receive treatment with TV-1106 or GENOTROPIN in a 4:1 allocation ratio stratified by a combination of gender and oral estrogen use at screening (female using oral estrogen, female not using oral estrogen, and male). | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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TV-1106 | ||||||||||||||||||
Arm description |
TV-1106 was injected once weekly on the same day and at approximately the same time (between 1800 and 2200) for the 48-week open-label treatment. The starting dose of TV-1106 was determined by multiplying the individual starting dose of previously taken daily rhGH (eg, GENOTROPIN) by a conversion factor of 28. The TV-1106 dose was adjusted so that the patient’s dose resulted in IGF-1 SDS between -0.5 and +1.5. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
TV-1106
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Investigational medicinal product code |
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Other name |
long-acting growth hormone, albutropin
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
TV-1106 was administered on a weekly basis subcutaneously, either self-administered or administered during visits to the study site. The TV-1106 dose was adjusted so that the patient’s dose resulted in IGF-1 SDS between -0.5 and +1.5. Dose increments were 2.5 mg or 5.0 mg based on patient demographics.
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Arm title
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Genotropin | ||||||||||||||||||
Arm description |
The dose levels of GENOTROPIN were the same as the stable rhGH dose taken by each patient before the study, and were expected to range from 0.2 to 1.8 mg. GENOTROPIN was given as a daily subcutaneous injection for 48 weeks. | ||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||
Investigational medicinal product name |
Genotropin
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Investigational medicinal product code |
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Other name |
GENOTROPIN®, somatropin [rDNA origin]
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
The dose levels of GENOTROPIN were the same as the stable rhGH dose taken by each patient before the study, and were expected to range from 0.2 to 1.8 mg. GENOTROPIN was given as a daily subcutaneous injection.
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Baseline characteristics reporting groups
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Reporting group title |
TV-1106
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Reporting group description |
TV-1106 was injected once weekly on the same day and at approximately the same time (between 1800 and 2200) for the 48-week open-label treatment. The starting dose of TV-1106 was determined by multiplying the individual starting dose of previously taken daily rhGH (eg, GENOTROPIN) by a conversion factor of 28. The TV-1106 dose was adjusted so that the patient’s dose resulted in IGF-1 SDS between -0.5 and +1.5. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Genotropin
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Reporting group description |
The dose levels of GENOTROPIN were the same as the stable rhGH dose taken by each patient before the study, and were expected to range from 0.2 to 1.8 mg. GENOTROPIN was given as a daily subcutaneous injection for 48 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
TV-1106
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Reporting group description |
TV-1106 was injected once weekly on the same day and at approximately the same time (between 1800 and 2200) for the 48-week open-label treatment. The starting dose of TV-1106 was determined by multiplying the individual starting dose of previously taken daily rhGH (eg, GENOTROPIN) by a conversion factor of 28. The TV-1106 dose was adjusted so that the patient’s dose resulted in IGF-1 SDS between -0.5 and +1.5. | ||
Reporting group title |
Genotropin
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Reporting group description |
The dose levels of GENOTROPIN were the same as the stable rhGH dose taken by each patient before the study, and were expected to range from 0.2 to 1.8 mg. GENOTROPIN was given as a daily subcutaneous injection for 48 weeks. | ||
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End point title |
Percentage of Participants with Treatment-emergent Adverse Events [1] | ||||||||||||||||||||||||||||||
End point description |
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.
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End point type |
Primary
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End point timeframe |
Day 1 up to Week 35
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Because the study was terminated while enrollment was ongoing, the sample size was smaller than the planned 140 patients; 34 patients enrolled, 7 of whom received GENOTROPIN and 27 of whom received TV-1106 . Thus limited analyses were completed and no conclusions were reached. |
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| Notes [2] - Safety population [3] - Safety population |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
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End point title |
Percentage of Participants with Potentially Clinically Significant Abnormal Blood and Urine Test Results [4] | ||||||||||||||||||||||||
End point description |
Parameters with potentially clinically significant abnormal test results include
- Serum chemistry: gamma glutamyl transferase
- Hematology: leukocytes, eosinophils/leukocytes
- Urinalysis: ketones
Significance criteria are listed below with the test. ULN = upper limit of normal
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End point type |
Primary
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End point timeframe |
Day 1 up to Week 35
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Because the study was terminated while enrollment was ongoing, the sample size was smaller than the planned 140 patients; 34 patients enrolled, 7 of whom received GENOTROPIN and 27 of whom received TV-1106 . Thus limited analyses were completed and no conclusions were reached. |
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| Notes [5] - Safety population [6] - Safety population |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Percentage of Participants with Potentially Clinically Significant Vital Signs [7] | ||||||||||||||||||
End point description |
Significance criteria for vital signs that showed potentially clinically significant findings are:
- Pulse rate: decrease 15 beats per minute (bpm) to <= 50 bpm
- Diastolic blood pressure: decrease 15 mmHg to <= 50 mmHg
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End point type |
Primary
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End point timeframe |
Day 1 up to Week 35
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| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Because the study was terminated while enrollment was ongoing, the sample size was smaller than the planned 140 patients; 34 patients enrolled, 7 of whom received GENOTROPIN and 27 of whom received TV-1106 . Thus limited analyses were completed and no conclusions were reached. |
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| Notes [8] - Safety population [9] - Safety population |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Shift From Baseline To Endpoint in Electrocardiogram Findings [10] | ||||||||||||||||||||||||||||||
End point description |
Shifts represented as baseline - endpoint value (last observed post-baseline value). Endpoint is the last observed value.
Abnormal NCS indicates an abnormal but not clinically significant finding. Abnormal CS indicates an
abnormal and clinically significant finding.
Values of 'Missing' indicate patients who did not have both a baseline and treatment finding.
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End point type |
Primary
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End point timeframe |
Baseline (Day 1, pre-dose), Endpoint (up to Week 35)
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| Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Because the study was terminated while enrollment was ongoing, the sample size was smaller than the planned 140 patients; 34 patients enrolled, 7 of whom received GENOTROPIN and 27 of whom received TV-1106 . Thus limited analyses were completed and no conclusions were reached. |
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| Notes [11] - Safety population [12] - Safety population |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
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End point title |
Thyroid Stimulating Hormone (TSH) Values at Baseline and Endpoint [13] | ||||||||||||||||||
End point description |
Observed values of TSH which is the first of three thyroid hormones measured.
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End point type |
Primary
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End point timeframe |
Baseline (Day 1, pre-dose), Endpoint (up to Week 35)
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| Notes [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Because the study was terminated while enrollment was ongoing, the sample size was smaller than the planned 140 patients; 34 patients enrolled, 7 of whom received GENOTROPIN and 27 of whom received TV-1106 . Thus limited analyses were completed and no conclusions were reached. |
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| Notes [14] - Safety population [15] - Safety population |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Free Thyroxin (free T4) Values at Baseline and Endpoint [16] | ||||||||||||||||||
End point description |
Observed values of Free T4 which is the second of three thyroid hormones measured.
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End point type |
Primary
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End point timeframe |
Baseline (Day 1, pre-dose), Endpoint (up to Week 35)
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| Notes [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Because the study was terminated while enrollment was ongoing, the sample size was smaller than the planned 140 patients; 34 patients enrolled, 7 of whom received GENOTROPIN and 27 of whom received TV-1106 . Thus limited analyses were completed and no conclusions were reached. |
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| Notes [17] - Safety population [18] - Safety population |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Triiodothyronine (Total T3) Values at Baseline and Endpoint [19] | ||||||||||||||||||
End point description |
Observed values of Total T3 which is the third of three thyroid hormones measured.
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End point type |
Primary
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End point timeframe |
Baseline (Day 1, pre-dose), Endpoint (up to Week 35)
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| Notes [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Because the study was terminated while enrollment was ongoing, the sample size was smaller than the planned 140 patients; 34 patients enrolled, 7 of whom received GENOTROPIN and 27 of whom received TV-1106 . Thus limited analyses were completed and no conclusions were reached. |
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| Notes [20] - Safety population [21] - Safety population |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Glycated Hemoglobin (HbA1c) Values at Baseline and Endpoint [22] | ||||||||||||||||||
End point description |
Glycated Hemoglobin (HbA1c) is a measure of glucose homeostasis.
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End point type |
Primary
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End point timeframe |
Baseline (Day 1, pre-dose), Endpoint (up to Week 35)
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| Notes [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Because the study was terminated while enrollment was ongoing, the sample size was smaller than the planned 140 patients; 34 patients enrolled, 7 of whom received GENOTROPIN and 27 of whom received TV-1106 . Thus limited analyses were completed and no conclusions were reached. |
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| Notes [23] - Safety population [24] - Safety population |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Fasting Blood Glucose Values at Baseline and Endpoint [25] | ||||||||||||||||||
End point description |
Fasting blood glucose is another measure of glucose homeostasis.
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End point type |
Primary
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End point timeframe |
Baseline (Day 1, pre-dose), Endpoint (up to Week 35)
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| Notes [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Because the study was terminated while enrollment was ongoing, the sample size was smaller than the planned 140 patients; 34 patients enrolled, 7 of whom received GENOTROPIN and 27 of whom received TV-1106 . Thus limited analyses were completed and no conclusions were reached. |
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| Notes [26] - Safety population [27] - Safety population |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Insulin Values at Baseline and Endpoint [28] | ||||||||||||||||||
End point description |
Insulin is another measure of glucose homeostasis.
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End point type |
Primary
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End point timeframe |
Baseline (Day 1, pre-dose), Endpoint (up to Week 35)
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| Notes [28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Because the study was terminated while enrollment was ongoing, the sample size was smaller than the planned 140 patients; 34 patients enrolled, 7 of whom received GENOTROPIN and 27 of whom received TV-1106 . Thus limited analyses were completed and no conclusions were reached. |
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| Notes [29] - Safety population [30] - Safety population |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Local Tolerability Assessed by Injection Site Reactions [31] | |||||||||||||||||||||||||||
End point description |
Participants reporting at least one injection site reaction.
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End point type |
Primary
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End point timeframe |
Day 1 up to Week 35
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| Notes [31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Because the study was terminated while enrollment was ongoing, the sample size was smaller than the planned 140 patients; 34 patients enrolled, 7 of whom received GENOTROPIN and 27 of whom received TV-1106 . Thus limited analyses were completed and no conclusions were reached. |
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| Notes [32] - Safety population [33] - Safety population |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||
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End point title |
Peak and Trough Insulin-Like Growth Factor 1 Standard Deviation Scores (IGF-I SDS) During the Study | ||||||||||||||||||
End point description |
Peak reflects maximum value of IGF-I SDS from samples taken on Days 1 or 2 following TV-1106 dose (at Weeks 4, 8, & 16). For Genotropin, peak is the maximum IGF-I SDS value across the entire study.
Trough reflects minimum value of IGF-I SDS results from samples taken on Day 7, just prior to the next dose of TV-1106 (at Weeks 12 and 24).
For Genotropin, trough is the minimum IGF-I SDS value across the entire study.
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End point type |
Secondary
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End point timeframe |
Day 1 up to Week 35
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| Notes [34] - Safety population [35] - Safety population |
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| No statistical analyses for this end point | |||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Day 1 to Week 35
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.1
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Reporting groups
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Reporting group title |
TV-1106
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Reporting group description |
TV-1106 was injected once weekly on the same day and at approximately the same time (between 1800 and 2200) for the 48-week open-label treatment. The starting dose of TV-1106 was determined by multiplying the individual starting dose of previously taken daily rhGH (eg, GENOTROPIN) by a conversion factor of 28. The TV-1106 dose was adjusted so that the patient’s dose resulted in IGF-1 SDS between -0.5 and +1.5. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Genotropin
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Reporting group description |
The dose levels of GENOTROPIN were the same as the stable rhGH dose taken by each patient before the study, and were expected to range from 0.2 to 1.8 mg. GENOTROPIN was given as a daily subcutaneous injection for 48 weeks. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| The sample size was smaller than the planned 140 patients; 34 patients enrolled. Limited analyses were completed and no conclusions reached. | |||
