Primary Immune Thrombocytopenia (ITP)PTI PARINCT02042560
Study of Immune Thrombocytopenia Pathogenesis:
An observational study of Primary Immune Thrombocytopenia (ITP), run by Centre Hospitalier Universitaire Dijon at 3 sites in France.
Trial summary
Immune thrombocytopenia (ITP) is an autoimmune disease characterized by a low platelet count responsible for bleedings. The disease is mostly mediated by antiplatelet antibodies produced by specific B cells. However, T cells are also involved but their role is not completely understood. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Immune Thrombocytopenia (ITP)
- What is being tested?
- Blood samples and Spleen samples
- How many people
- 89 participants
- Where
- 3 sitesFrance
- Study dates
- 4 May 2011to 12 Mar 2015
- Phase
- Observational
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with ITP
Who may be able to join
- Patients with ITP, defined as thrombocytopenia < 30 G/L, once causes related to infection, medication, systemic auto-immune disease or malignant hemopathy have been ruled out
- persons who have provided written informed consent
Who cannot join
- persons without national health insurance
- persons under 18 years old
- patients under guardianship
- pregnancy
- subjects suffering from a systemic auto-immune disease, cancer, a progressive infection, or treated with steroids or immunosuppressants.
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Besançon
Besançon, 25000
CHU de Dijon
Dijon, 21079
CHU de METZ
Metz, 57000
About this study
Official title: Study of Immune Thrombocytopenia Pathogenesis: a Multicenter, Open and Controlled Study.
Immune thrombocytopenia (ITP) is an autoimmune disease characterized by a low platelet count responsible for bleedings. The disease is mostly mediated by antiplatelet antibodies produced by specific B cells. However, T cells are also involved but their role is not completely understood.
The aim of this study is to determine the implication of T cells in the pathogenesis of ITP, notably regulatory T cells (Treg, CD4+CD25highFoxp3+), cytotoxic T cells (CD3+CD8+) and T follicular helper cells (TFH, CD3+CD4+CXCR5+PD-1+ICOS+), in blood and in the spleen of primary ITP patients, compared to healthy controls.
- Conditions
- Primary Immune Thrombocytopenia (ITP)
- Being tested
- Blood samples, Spleen samples
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
Spleen samplesOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with ITP | Not described Receives: Other: Blood samples; Other: Spleen samples | |
| Controls | Not described Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood level T cell in ITP patients and in healthy controls
Measured: baseline
blood level T cell in ITP patients after treatments
Measured: change from baseline at 4 to 8 weeks
Secondary outcomes (3)
blood level splenic T cell in ITP patients and in healthy controls
Measured: baseline
frequency of innate immune cells (dendritic cells, monocytes, NK cells…) and their functions in blood and spleens, in patients and in controls
Measured: through study completion, an average of 3 years
level of T follicular helper cell
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study start4 May 2011
- Primary completion12 Mar 2015
- Study completion12 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune Thrombocytopenia (ITP)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042560
- Sponsor's protocol ID
- LORCERIE PARI 2010
- Acronym
- PTI PARI
- Status last verified
- Mar 2018
- First submitted
- 17 Jan 2014
- Last updated
- 15 Mar 2018
- Results posted
- No