Immune Thrombocytopenic PurpuraPhase 3IMMUNOTINCT04070599
Initial Hemato-immunological Profile on the Evolution of Immunological Thrombopenic Purpura.
A Phase 3 study testing Collection of biological samples in people with Immune Thrombocytopenic Purpura and Autoimmune Thrombocytopenia, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
This study aims to determine the hemato-immunological parameters predictive of the evolution of a Immune thrombocytopenic purpura (ITP) towards chronicity, and to identify possible differences between the child and the adult. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Immune Thrombocytopenic Purpura, Autoimmune Thrombocytopenia, Thrombopenia
- What is being tested?
- Collection of biological samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2011to 5 Mar 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Minor patients aged 2 to 18 recruited at the Children's Hospital, in the service of Prof. Y. PEREL, Dr. N. ALADJIDI, CEREVANCE,
- Adult patients (> 18 years old) recruited at the Haut-Lévêque hospital, Pr JL PELLEGRIN, Pr JF VIALLARD, GECAI,
- Patient with acute Immune thrombocytopenic purpura, seen at initial diagnosis or within 8 days (defined as thrombocytopenia <100 G / L, after an infectious cause, drug or related to autoimmune disease, hematological malignancy or deficit Immune have been eliminated, Rodeghiero criteria, 2009).
- Patient who received immunoglobulins more than 4 weeks before inclusion
- Written consent given by the patient, if he is of age, or by the person (s) having parental authority
- Patient affiliated or beneficiary of a social security scheme
Who cannot join
- Patient who has received specific treatment from an Immune thrombocytopenic purpura
- Patient with secondary Immune thrombocytopenic purpura (hematological malignancy, autoimmune disease, immunodeficiency, pregnancy)
- Patient placed under the protection of justice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Value of the Initial Hemato-immunological Profile on the Evolution of Immunological Thrombopenic Purpura of Children and Adults.
This study aims to determine the hemato-immunological parameters predictive of the evolution of a Immune thrombocytopenic purpura (ITP) towards chronicity, and to identify possible differences between the child and the adult.
Read the detailed description
Immune thrombocytopenic purpura (ITP) is a rare autoimmune thrombocytopenia whose incidence is 2 to 5 cases / 100,000 inhabitants / year. The potentially serious haemorrhagic risk is the major issue of management. A recent international consensus conference classifies PTI according to the duration of thrombocytopenia: acute ITP (<3 months), persistent ITP (3-12 months) and chronic ITP (> 12 months) (Rodeghiero 2009). In the acute or persistent phase, polyvalent immunoglobulins (IVIG) and / or corticosteroids are proposed. In the chronic phase, splenectomy is a possible cure for 70% of patients. No predictor of treatment response is known.
The pathophysiology of ITP is multifactorial: platelet phagocytosis, mediated by autoantibody, macrophages of the reticuloendothelial system, and destruction in the spleen, genetic background and / or environmental factor favoring the role of certain lymphocyte subpopulations, cytotoxic or regulatory T, via their cytokine environment, abnormalities of thrombopoiesis.
ITP affects children as well as adults, but the evolutionary profile is very different. In children, ITP, which is often post-infectious, is acute in 80% of cases, whereas ITP in adults has a chronic evolution in 80% of cases. The primary diagnostic and therapeutic practices are similar. The reasons for these evolutionary differences are not known and little studied.
Is the orientation of the hemato-immunological response observed during the first episode of ITP different in children and adults? Do these differences explain the evolutionary specificities of the two age groups? Are there hematologic parameters predictive of a response to initial treatments?
- Being tested
- Collection of biological samples
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of biological samplesBiological
A collection of biological samples will be carried out, with the remainders of the immunological samples taken on dry tube: the serum of the patients, taken at the initial diagnosis, will be kept frozen at -20 ° C.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Study of lymphocyte subpopulations, cytokine assays, identification of autoantibodies, study of CD40 platelet ligand, thrombopoietin assay Receives: Biological: Collection of biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission yes/no
The status of Immune thrombocytopenic purpura in adult and pediatric patients will be determined at 12 months of initial diagnosis according to the Rodeghiero criteria: complete remission if the platelet count is> 100 G / L. A non-complete remission patient at 12 months will be considered to have a chronic Immune thrombocytopenic purpura.
Measured: At 12 months of initial diagnosis
Secondary outcomes (2)
Response to the first course of first-line treatments (Immunoglobulin IV or corticosteroid)
Defined by the Rodeghiero criteria: complete response (platelet count> 100 G / L and no bleeding), response (platelet count> 30 G / L and increase> 2 times the basal rate and no bleeding), no response (platelet count <30 G / L or increase <2 times the basal rate or bleeding).
Measured: At Day14
Response to the first course of first-line treatments (Immunoglobulin IV or corticosteroid)
Defined by the Rodeghiero criteria: complete response (platelet count> 100 G / L and no bleeding), response (platelet count> 30 G / L and increase> 2 times the basal rate and no bleeding), no response (platelet count <30 G / L or increase <2 times the basal rate or bleeding).
Measured: At Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start12 Apr 2011
- Primary completion5 Mar 2014
- Study completion5 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Immune Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carine GRIEB, Dr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070599
- Sponsor's protocol ID
- CHUBX 2010/30
- Other IDs
- 2010-A01367-32
- Acronym
- IMMUNOTI
- Status last verified
- Aug 2019
- First submitted
- 22 Aug 2019
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arveiler B, Lasseaux E, Morice-Picard F. [Clinical and genetic aspects of albinism]. Presse Med. 2017 Jul-Aug;46(7-8 Pt 1):648-654. doi: 10.1016/j.lpm.2017.05.020. Epub 2017 Jul 19. French.
PubMed 28734636Michaud V, Lasseaux E, Plaisant C, Verloes A, Perdomo-Trujillo Y, Hamel C, Elcioglu NH, Leroy B, Kaplan J, Jouk PS, Lacombe D, Fergelot P, Morice-Picard F, Arveiler B. Clinico-molecular analysis of eleven patients with Hermansky-Pudlak type 5 syndrome, a mild form of HPS. Pigment Cell Melanoma Res. 2017 Jan;30(6):563-570. doi: 10.1111/pcmr.12608. Epub 2017 Oct 20.
PubMed 28640947
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of the Initial Hemato-immunological Profile on the Evolution of Immunological Thrombopenic Purpura of Children and Adults.
- ClinicalTrials.gov ID
- NCT04070599
- Acronym / sponsor ID
- IMMUNOTI / CHUBX 2010/30
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 12 Apr 2011 (actual)
- Primary completion
- 5 Mar 2014 (actual)
- Study completion
- 5 Mar 2014 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the hemato-immunological parameters predictive of the evolution of a Immune thrombocytopenic purpura (ITP) towards chronicity, and to identify possible differences between the child and the adult.
Detailed description
Immune thrombocytopenic purpura (ITP) is a rare autoimmune thrombocytopenia whose incidence is 2 to 5 cases / 100,000 inhabitants / year. The potentially serious haemorrhagic risk is the major issue of management. A recent international consensus conference classifies PTI according to the duration of thrombocytopenia: acute ITP (<3 months), persistent ITP (3-12 months) and chronic ITP (> 12 months) (Rodeghiero 2009). In the acute or persistent phase, polyvalent immunoglobulins (IVIG) and / or corticosteroids are proposed. In the chronic phase, splenectomy is a possible cure for 70% of patients. No predictor of treatment response is known.
The pathophysiology of ITP is multifactorial: platelet phagocytosis, mediated by autoantibody, macrophages of the reticuloendothelial system, and destruction in the spleen, genetic background and / or environmental factor favoring the role of certain lymphocyte subpopulations, cytotoxic or regulatory T, via their cytokine environment, abnormalities of thrombopoiesis.
ITP affects children as well as adults, but the evolutionary profile is very different. In children, ITP, which is often post-infectious, is acute in 80% of cases, whereas ITP in adults has a chronic evolution in 80% of cases. The primary diagnostic and therapeutic practices are similar. The reasons for these evolutionary differences are not known and little studied.
Is the orientation of the hemato-immunological response observed during the first episode of ITP different in children and adults? Do these differences explain the evolutionary specificities of the two age groups? Are there hematologic parameters predictive of a response to initial treatments?
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Biological: Collection of biological samplesStudy of lymphocyte subpopulations, cytokine assays, identification of autoantibodies, study of CD40 platelet ligand, thrombopoietin assay |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Minor patients aged 2 to 18 recruited at the Children's Hospital, in the service of Prof. Y. PEREL, Dr. N. ALADJIDI, CEREVANCE,
- Adult patients (> 18 years old) recruited at the Haut-Lévêque hospital, Pr JL PELLEGRIN, Pr JF VIALLARD, GECAI,
- Patient with acute Immune thrombocytopenic purpura, seen at initial diagnosis or within 8 days (defined as thrombocytopenia <100 G / L, after an infectious cause, drug or related to autoimmune disease, hematological malignancy or deficit Immune have been eliminated, Rodeghiero criteria, 2009).
- Patient who received immunoglobulins more than 4 weeks before inclusion
- Written consent given by the patient, if he is of age, or by the person (s) having parental authority
Key exclusion criteria (3 listed)
- Patient who has received specific treatment from an Immune thrombocytopenic purpura
- Patient with secondary Immune thrombocytopenic purpura (hematological malignancy, autoimmune disease, immunodeficiency, pregnancy)
- Patient placed under the protection of justice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of biological samplesA collection of biological samples will be carried out, with the remainders of the immunological samples taken on dry tube: the serum of the patients, taken at the initial diagnosis, will be kept frozen at -20 ° C. | Biological | Single arm |
Primary outcome
Complete remission yes/no
Time frame: At 12 months of initial diagnosis
The status of Immune thrombocytopenic purpura in adult and pediatric patients will be determined at 12 months of initial diagnosis according to the Rodeghiero criteria: complete remission if the platelet count is> 100 G / L. A non-complete remission patient at 12 months will be considered to have a chronic Immune thrombocytopenic purpura.
2 secondary outcomes
Response to the first course of first-line treatments (Immunoglobulin IV or corticosteroid)
Time frame: At Day14
Response to the first course of first-line treatments (Immunoglobulin IV or corticosteroid)
Time frame: At Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Results publication: PubMed 28734636Arveiler B, Lasseaux E, Morice-Picard F. [Clinical and genetic aspects of albinism]. Presse Med. 2017 Jul-Aug;46(7-8 Pt 1):648-654. doi: 10.1016/j.lpm.2017.05.020. Epub 2017 Jul 19. French.
- Results publication: PubMed 28640947Michaud V, Lasseaux E, Plaisant C, Verloes A, Perdomo-Trujillo Y, Hamel C, Elcioglu NH, Leroy B, Kaplan J, Jouk PS, Lacombe D, Fergelot P, Morice-Picard F, Arveiler B. Clinico-molecular analysis of eleven patients with Hermansky-Pudlak type 5 syndrome, a mild form of HPS. Pigment Cell Melanoma Res. 2017 Jan;30(6):563-570. doi: 10.1111/pcmr.12608. Epub 2017 Oct 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carine GRIEB, Dr principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Collection of biological samples in people with Immune Thrombocytopenic Purpura and Autoimmune Thrombocytopenia, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission yes/no (time frame: At 12 months of initial diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04070599, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.