Clinical Trial Results:
ARNS HC 21 VASCU IL-2, evaluation of the cellular immune response, clinical efficacy and tolerance after IL-2 therapy in HCV-related Vasculitis patients, resistant to conventional therapy
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Summary
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EudraCT number |
2006-004039-31 |
Trial protocol |
FR |
Global end of trial date |
16 Sep 2010
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Results information
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Results version number |
v1(current) |
This version publication date |
08 Mar 2024
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First version publication date |
08 Mar 2024
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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 |
ANRS HC 21 VASCU IL-2
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00574652 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Inserm-ANRS
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Sponsor organisation address |
101 rue de Tolbiac, Paris, France, 75013
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Public contact |
Pr. Pactrice CACOUB, Hôpital de la Pitié, +33 1 42 17 80 09, patrice.cacoub@aphp.fr
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Scientific contact |
Pr. Pactrice CACOUB, Hôpital de la Pitié, +33 1 42 17 80 09, patrice.cacoub@aphp.fr
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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 |
16 Sep 2010
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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 |
16 Sep 2010
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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 of this trial is to evaluate the cellular immune response after IL-2 therapy in HCV-MC Vasculitis patients, resistant to conventional therapy.
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Protection of trial subjects |
This study was conducted in accordance with the updated Declaration of Helsinki, in compliance with the approved protocol and its amendments, the International Council for Harmonisation guideline for Good Clinical Practice (ICH GCP), and French regulatory requirements.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
19 Mar 2008
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety, Efficacy | ||
Long term follow-up duration |
7 Months | ||
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 |
France: 10
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Worldwide total number of subjects |
10
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EEA total number of subjects |
10
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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) |
7
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From 65 to 84 years |
3
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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 |
Main criteria: Inclusion: at least 18 years old, Caucasian origin, chronic active HCV infection, patients with cryoglobulinemia vasculitis resistant to conventional therapy. Non-inclusion: HBs Ag+ and/or HBV+ PCR, HIV+ serology, Cirrhosis Child B or C. | ||||||
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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 |
Not applicable
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Blinding used |
Not blinded | ||||||
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Arms
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Arm title
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Vascu IL-2 arm | ||||||
Arm description |
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Arm type |
Experimental | ||||||
Investigational medicinal product name |
Interleukine-2
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Investigational medicinal product code |
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Other name |
IL-2, Proleukine
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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 |
IL-2 will be injected subcutaneaously from D1 to D5 every 3 weeks over 4 consecutive cycles (W1, W3, W6 and W9).
W1: dose of 1.5M IU/day by injection of 0.25mL.
W3, W6 and W9: 3M IU/day by injection of 0.5mL.
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Baseline characteristics reporting groups
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Reporting group title |
Vascu IL-2 arm
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Reporting group description |
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End points reporting groups
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Reporting group title |
Vascu IL-2 arm
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Reporting group description |
- | ||
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End point title |
Regulatory T cell [1] | ||||||||
End point description |
Follow-up of Treg and of HCV cellular immune response before, during and after IL-2 therapy.
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End point type |
Primary
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End point timeframe |
Difference between W9 and D0 and post IL-2 treatment.
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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: This endpoint concerns a single arm, adding statistical analyses create errors. |
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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 |
Participants reported adverse events during the entire trial.
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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 |
17.0
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Reporting groups
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Reporting group title |
Vascu IL-2 arm
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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16 Dec 2009 |
The substantial modifications included in the amendment 1 of the protocol are:
- the extension of the inclusion period for an additional 6 months
- the inclusion of 10 patients instead of the 15 initially planned. |
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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 | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/22129253 |
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