Condition or disease | Intervention/treatment | Phase |
---|---|---|
Recurrent Miscarriage | Drug: low-dose IL-2 | Phase 1 Phase 2 |
About 1 to 3% of women of childbearing age have repeated early spontaneous miscarriages that may be related to parental chromosomal abnormalities, uterine abnormalities, hormonal causes, infectious etiology, thrombophilia ... When one of these known causes is excluded, it is unexplained miscarriages of which half would be due to an immunological deregulation of the mother causing a decrease of the tolerance to the fetus.
In this context, the stimulation of regulatory T cells (Tregs) by low dose IL-2 is a therapeutic option with a rational, preclinical and clinical data very favorable.
In humans, low dose IL-2 allows preferential activation of Tregs and is very well tolerated. Several therapeutic trials have shown its efficiencies.
These elements make it possible to envisage the development of a therapeutic to prevent fetal rejection by IL2-fd on the women with spontaneous miscarriages by an immunological deregulation.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Regulatory T-cell Induction by Low-dose Interleukin-2 in Women With Unexplained Repeated Spontaneous Early Miscarriages |
Actual Study Start Date : | January 5, 2021 |
Estimated Primary Completion Date : | February 5, 2024 |
Estimated Study Completion Date : | February 5, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
Low-dose IL-2
|
Drug: low-dose IL-2
Subcutaneous injection of low dose of IL-2 for induction course of 5 days, the 10th day after the beginning of periods. At most 5 courses of low dose of IL-2.
Other Name: interleukin-2
|
Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David Klatzmann, Pr | +331 42 16 74 61 | david.klatzmann@upmc.fr | |
Contact: Arsène Mékinian, Dr | +33 1 48 02 63 96 | arsene.mekinian@aphp.fr |
France | |
Mekinian | Recruiting |
Paris, Hopital Saint Antoine, France, 75012 | |
Contact: Arsene Mekinian, Dr | |
Sub-Investigator: Olivier Fain, Pr | |
Sub-Investigator: roberta Lorenzon, Dr | |
Principal Investigator: Arsene Mekinian, DR | |
Bornes | Not yet recruiting |
Paris, Hopital Tenon, France, 75020 | |
Contact: Marie Bornes, Pr | |
Principal Investigator: Marie Bornes, Pr | |
Sub-Investigator: Audrey rosefort, Pr | |
Kayem | Not yet recruiting |
Paris, Hopital Trousseau, France, 75012 | |
Contact: Gilles Kayem, Pr | |
Principal Investigator: Gilles Kayem, Pr | |
Sub-Investigator: lucille cedille, Dr |
Principal Investigator: | David Klatzmann, Pr | Pitié Salpètrière APHP Paris | |
Study Director: | Arsene Mékinian, Dr | Saint Antoine APHP Paris | |
Study Director: | Gilles Kayem, Pr | Trousseau APHP Paris |
Tracking Information | ||||||||||
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First Submitted Date ICMJE | March 14, 2019 | |||||||||
First Posted Date ICMJE | June 3, 2019 | |||||||||
Last Update Posted Date | March 9, 2021 | |||||||||
Actual Study Start Date ICMJE | January 5, 2021 | |||||||||
Estimated Primary Completion Date | February 5, 2024 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||||||||
Change History | ||||||||||
Current Secondary Outcome Measures ICMJE |
|
|||||||||
Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | Low-dose Interleukin-2 in Women With Unexplained Miscarriages | |||||||||
Official Title ICMJE | Regulatory T-cell Induction by Low-dose Interleukin-2 in Women With Unexplained Repeated Spontaneous Early Miscarriages | |||||||||
Brief Summary | The purpose of this study is to demonstrate the ability of low dose IL-2 to stimulate peripheral blood Tregs of women with unexplained repeated early spontaneous miscarriages for development of a therapy to prevent fetal rejection by low dose IL-2. | |||||||||
Detailed Description |
About 1 to 3% of women of childbearing age have repeated early spontaneous miscarriages that may be related to parental chromosomal abnormalities, uterine abnormalities, hormonal causes, infectious etiology, thrombophilia ... When one of these known causes is excluded, it is unexplained miscarriages of which half would be due to an immunological deregulation of the mother causing a decrease of the tolerance to the fetus. In this context, the stimulation of regulatory T cells (Tregs) by low dose IL-2 is a therapeutic option with a rational, preclinical and clinical data very favorable. In humans, low dose IL-2 allows preferential activation of Tregs and is very well tolerated. Several therapeutic trials have shown its efficiencies. These elements make it possible to envisage the development of a therapeutic to prevent fetal rejection by IL2-fd on the women with spontaneous miscarriages by an immunological deregulation. |
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Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Phase 1 Phase 2 |
|||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||||||||
Condition ICMJE | Recurrent Miscarriage | |||||||||
Intervention ICMJE | Drug: low-dose IL-2
Subcutaneous injection of low dose of IL-2 for induction course of 5 days, the 10th day after the beginning of periods. At most 5 courses of low dose of IL-2.
Other Name: interleukin-2
|
|||||||||
Study Arms ICMJE | Experimental: 1
Low-dose IL-2
Intervention: Drug: low-dose IL-2
|
|||||||||
Publications * | Not Provided | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||
Recruitment Status ICMJE | Recruiting | |||||||||
Estimated Enrollment ICMJE |
10 | |||||||||
Original Estimated Enrollment ICMJE | Same as current | |||||||||
Estimated Study Completion Date ICMJE | February 5, 2025 | |||||||||
Estimated Primary Completion Date | February 5, 2024 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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Sex/Gender ICMJE |
|
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Ages ICMJE | 18 Years to 40 Years (Adult) | |||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT03970954 | |||||||||
Other Study ID Numbers ICMJE | APHP 180256 | |||||||||
Has Data Monitoring Committee | No | |||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Assistance Publique - Hôpitaux de Paris | |||||||||
Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | |||||||||
Collaborators ICMJE | Iltoo Pharma | |||||||||
Investigators ICMJE |
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PRS Account | Assistance Publique - Hôpitaux de Paris | |||||||||
Verification Date | March 2021 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |