Clinical Trial Results:
A follow-up study to examine the presence of anti-human growth hormone (anti-hGH) antibodies following a randomised, open-label, parallel-group, multi-centre trial (FE 999905 CS07) in which the efficacy and safety of 12 months’ treatment with one daily dose of ZOMACTON were compared to one daily dose of GENOTROPIN.
Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
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Summary
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EudraCT number |
2014-000627-24 |
Trial protocol |
HU PL |
Global end of trial date |
17 Aug 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
22 Jun 2016
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First version publication date |
22 Jun 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 |
000134
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02173821 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Ferring Pharmaceuticals A/S
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Sponsor organisation address |
Kay Fiskers Plads 11, Copenhagen S, Denmark, 2300
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Public contact |
Clinical Development Support, Ferring Pharmaceuticals, DK0-Disclosure@ferring.com
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Scientific contact |
Clinical Development Support, Ferring Pharmaceuticals, DK0-Disclosure@ferring.com
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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 |
17 Aug 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
24 Apr 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
17 Aug 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To investigate the presence of remaining immunogenicity among previously anti-hGH antibody positive children who participated in the clinical study FE 999905 CS07 and were treated with one daily dose of 0.03 mg/kg ZOMACTON (10 mg/mL) or one daily dose of 0.03 mg/kg GENOTROPIN (12 mg/mL).
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Protection of trial subjects |
Before obtaining the consent from subject,parents(s)/legal representative, the Investigator appropriately explained the aims, methods, anticipated benefits, potential hazards, and any other aspects of the study which are relevant to the subjects' and parent(s)’/ legal representatives’ decision to participate. The Investigator explained to the subjects and their parent(s)/legal representatives about their right of freedom to refuse to enter the study or to withdraw from it at any time, without any consequences on subject's further care and without the need to justify their decision. The study was conducted in accordance with International Conference on Harmonization-Good Clinical Practice guidelines.
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Background therapy |
The enrolled subjects were treated with either one daily dose of 0.03 mg/kg ZOMACTON (10 mg/mL) or one daily dose of 0.03 mg/kg GENOTROPIN (12 mg/mL) for 12 months prior to participation in this follow-up study. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 Oct 2014
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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 |
Poland: 6
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Country: Number of subjects enrolled |
Romania: 1
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Country: Number of subjects enrolled |
Hungary: 1
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Country: Number of subjects enrolled |
Israel: 7
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Country: Number of subjects enrolled |
Ukraine: 8
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Worldwide total number of subjects |
23
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EEA total number of subjects |
8
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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) |
13
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Adolescents (12-17 years) |
10
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The study 000134 was a follow-up of subjects treated with one daily dose of 0.03 mg/kg ZOMACTON (10 mg/mL) or one daily dose of 0.03 mg/kg GENOTROPIN (12 mg) in the previously completed study FE 999905 CS07 who had confirmed positive formation of anti-hGH antibodies in at least one post-dose visit during the 12-month treatment period. | |||||||||
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Pre-assignment
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Screening details |
The study was conducted to follow subjects who were anti-hGH antibody positive in at least one post-dosing sample in the study FE 999905 CS07. | |||||||||
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Period 1
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Period 1 title |
Visit 1 (Follow-up) (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Not applicable
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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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ZOMACTON | |||||||||
Arm description |
One daily dose of 0.03 mg/kg ZOMACTON (10 mg/mL) administered for 12 months to subjects during their participation in the previous study FE 999905 CS07. No investigational medicinal product (IMP) was administered in the present follow-up study. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Somatropin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
No IMP was administered in the present follow-up study.
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Arm title
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GENOTROPIN | |||||||||
Arm description |
One daily dose of 0.03 mg/kg GENOTROPIN (12 mg/mL) administered for 12 months to subjects during their participation in the previous study FE 999905 CS07. No IMP was administered in the present follow-up study. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Somatropin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
No IMP was administered in the present follow-up study.
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Baseline characteristics reporting groups
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Reporting group title |
ZOMACTON
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Reporting group description |
One daily dose of 0.03 mg/kg ZOMACTON (10 mg/mL) administered for 12 months to subjects during their participation in the previous study FE 999905 CS07. No investigational medicinal product (IMP) was administered in the present follow-up study. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
GENOTROPIN
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Reporting group description |
One daily dose of 0.03 mg/kg GENOTROPIN (12 mg/mL) administered for 12 months to subjects during their participation in the previous study FE 999905 CS07. No IMP was administered in the present follow-up study. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Full Analysis Set (FAS)
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The FAS comprised all enrolled subjects with an anti-hGH antibody measurement (and who were included in the FAS of the previous study FE 999905 CS07).
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End points reporting groups
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Reporting group title |
ZOMACTON
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Reporting group description |
One daily dose of 0.03 mg/kg ZOMACTON (10 mg/mL) administered for 12 months to subjects during their participation in the previous study FE 999905 CS07. No investigational medicinal product (IMP) was administered in the present follow-up study. | ||
Reporting group title |
GENOTROPIN
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Reporting group description |
One daily dose of 0.03 mg/kg GENOTROPIN (12 mg/mL) administered for 12 months to subjects during their participation in the previous study FE 999905 CS07. No IMP was administered in the present follow-up study. | ||
Subject analysis set title |
Full Analysis Set (FAS)
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The FAS comprised all enrolled subjects with an anti-hGH antibody measurement (and who were included in the FAS of the previous study FE 999905 CS07).
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End point title |
Prevalence of anti-hGH antibodies [1] | ||||||||||||||||
End point description |
The prevalence of anti-hGH antibodies were estimated in the FAS by the percentage of subjects with positive anti-hGH antibodies and the exact 95% confidence interval (CI) (Clopper-Pearson) was provided.
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End point type |
Primary
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End point timeframe |
At Visit 1
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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: No hypothesis testing was conducted, and all statistics reported was descriptive. The data for immunogenicity was analysed and reported only for FAS, as FAS and Per Protocol analysis sets were identical. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Prevalence of neutralising antibodies in confirmed positive anti-hGH antibody samples | ||||||||||||||||
End point description |
The prevalence of neutralising antibodies in confirmed anti-hGH antibody positive samples were estimated in the FAS by the percentage of subjects with neutralising antibodies in the subgroup of subjects with confirmed anti-hGH antibodies positive samples and the associated exact 95% CI (Clopper-Pearson) was provided.
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End point type |
Secondary
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End point timeframe |
At Visit 1
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| Notes [2] - No subject in this group was confirmed anti-hGH antibody positive. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Binding capacity levels in confirmed anti-hGH antibody positive samples | ||||||||||||||||
End point description |
The binding capacity in confirmed anti-hGH antibody positive samples were described using descriptive summary statistics. The percentage of subjects with binding capacity ≤2 mg/L (i.e. below the threshold of clinical significance) in subjects with confirmed anti-hGH antibody positive samples were provided (including the exact 95% CI [Clopper-Pearson]).
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End point type |
Secondary
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End point timeframe |
At Visit 1
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| Notes [3] - No subject in this group was confirmed anti-hGH antibody positive. |
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| No statistical analyses for this end point | |||||||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
No treatment-emergent adverse events were collected during the study period. Any adverse events that occurred were reported under medical history.
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
Unknown | ||
Dictionary version |
0.0
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| Frequency threshold for reporting non-serious adverse events: 0% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Since no IMP was administered in this follow-up study, no adverse event data were collected. However, the investigator monitored the condition of the subject throughout the study from the time of obtaining informed consent until completion of the study. Any adverse events that occurred during this period were to be recorded under medical history. |
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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. | |||
| None reported | |||
