Clinical Trial Results:
A randomized, double-blind, placebo-controlled clinical trial assessing the efficacy of combining pasireotide with aspiration sclerotherapy to improve volume reduction of dominant hepatic cysts
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Summary
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EudraCT number |
2013-003168-29 |
Trial protocol |
NL |
Global end of trial date |
01 Apr 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
11 Oct 2022
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First version publication date |
11 Oct 2022
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Other versions |
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Summary report(s) |
Publication study 2013-003168-29 |
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 |
JDTW45115
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02048319 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Radboud University Medical Center
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Sponsor organisation address |
Geert Grooteplein zuid 10, Nijmegen, Netherlands,
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Public contact |
Wijnands, TFM, Radboud University Nijmegen Medical Center, 0031 243614760, t.wijnands@mdl.umcn.nl
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Scientific contact |
Wijnands, TFM, Radboud University Nijmegen Medical Center, 0031 243614760, t.wijnands@mdl.umcn.nl
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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 |
01 Apr 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Apr 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Apr 2016
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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 |
The main objective is to minimize fluid reaccumulation in the hepatic cyst after aspiration sclerotherapy in order to reduce cyst size.
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Protection of trial subjects |
Ethical approval of the study protocol was given by the Central Committee on Research Involving Human Subjects and by the local accredited Medical Research Ethics Committee of the region Arnhem-Nijmegen, the Netherlands (reference number: 2013/354).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Oct 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Netherlands: 34
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Worldwide total number of subjects |
34
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EEA total number of subjects |
34
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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) |
30
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From 65 to 84 years |
4
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||
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Pre-assignment
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Screening details |
During a 4 week screening period patients were screened based on the inclusion and exclusion criteria | |||||||||
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Period 1
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Period 1 title |
Baseline period (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Data analyst, Assessor | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Pasireotide treatment | |||||||||
Arm description |
pasireotide treatment long-acting release, 60 mg injection | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
pasireotide (long-acting release, 60 mg injection)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Injection
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Dosage and administration details |
pasireotide (long-acting release, 60 mg injection) two weeks prior to and two weeks following aspiration sclerotherapy
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Arm title
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Placebo | |||||||||
Arm description |
- | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Injection
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Dosage and administration details |
placebo
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End points reporting groups
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Reporting group title |
Pasireotide treatment
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Reporting group description |
pasireotide treatment long-acting release, 60 mg injection | ||
Reporting group title |
Placebo
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Reporting group description |
- | ||
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End point title |
Mean proportional change (%) in cyst diameter | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
four weeks after AS
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Statistical analysis title |
Intention-to-treat (ITT) analyses | |||||||||
Comparison groups |
Pasireotide treatment v Placebo
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Number of subjects included in analysis |
34
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Parameter type |
Mean proportional change | |||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
Serious adverse events <24 hours
Adverse events
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
WHO-ART | ||||||||||||||||||||||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
Pasireotide treatment
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Reporting group description |
- | ||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||
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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 | |||
