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Thrombocytopenia clinical trials

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NCT ID: NCT02899598 Withdrawn - Clinical trials for Neonatal Thrombocytopenia Isoimmunization Maternal-fetal

Genotyping of Human Platelet Alloantigens : Non-invasive Prenatal Diagnosis

Start date: July 27, 2023
Phase: N/A
Study type: Interventional

Neonatal thrombocytopenia isoimmunization maternal-fetal is related to maternal immunization against fetal platelet antigens with paternal origin not present in the mother. It is considered the equivalent of hemolytic disease of the newborn. The incidence of this disease is about 1 in 800-1000 births. The most severe forms associated petechiae, purpura or cephalhematoma at birth with a major risk of cerebral hemorrhages (20% to 25% of cases) can cause the death of the child (15%) or severe neurological troubles (15-30%) Biologic diagnosis requires the detection of anti-platelet antibodies with maternal determination of platelet phenotypes and genotypes of the two parents. The objective of this work is to develop specific molecular tools to fetal platelet genotyping from maternal blood. We are particularly interested to antigens HPA-1, HPA-5 , HPA-3 and HPA-4. We evaluate the sensitivity and specificity of this test by comparing these results with those obtained from an invasive sampling of amniotic fluid. This is a prospective study to assess the technical and diagnostic performance of a new molecular method noninvasive prenatal diagnosis of platelet genotyping.

NCT ID: NCT02892630 Recruiting - Pregnancy Clinical Trials

Immune Thrombocytopenia in Pregnancy

TIGRO
Start date: February 3, 2014
Phase: N/A
Study type: Observational

The pregnancy may activate flares of certain autoimmune diseases such as lupus. The influence of pregnancy on the evolution of ITP was never studied while this pathology affects firstly women old enough to procreate. Also, the influence of ITP on pregnancy (risk of obstetric complications) and on newborns (risk of neonatal thrombocytopenia) is rather unknown and never studied in a prospective study. The realization of a prospective study to answer these questions is necessary to allow us to inform better the patients affected by ITP and to define better in this context the strategy of supervision of the mother, the foetus and the newborn. The highlighting of risk factors of ITP flare or obstetric or neonatal complications will indeed allow the implementation of prevention measures. The conclusions of this study will allow us to adapt national guidelines for ITP during pregnancy.

NCT ID: NCT02891109 Completed - Clinical trials for Purpura, Thrombocytopenic, Idiopathic

Regulatory B Cells and Chronic Immune Thrombocytopenia

PTIREG
Start date: January 2015
Phase: N/A
Study type: Observational

The chronic immune thrombopenia is an autoimmune disease caused by B cells. These cells produce anti platelets and megakaryocytes antibodies. Some B cells, named regulatory B cells, are known to control other cells. Their action in chronic immune thrombopenia is actually unknown.

NCT ID: NCT02877706 Recruiting - Clinical trials for Immune Thrombocytopenia

French Registry of Adult Patients With Immune Thrombocytopenia and Autoimmune Hemolytic Anemia

CARMEN
Start date: June 2013
Phase:
Study type: Observational [Patient Registry]

CARMEN is a national, real-world clinical registry of all adult patients with incident diagnosis of Immune thrombocytopenia (ITP) or Autoimmune Hemolytic anemia (AIHA) patients in France. It is aimed at describing ITP and AIHA clinical features, assessing the real-world risk-benefit ratio of treatments and adherence to guidelines for ITP and AIHA management.

NCT ID: NCT02868099 Completed - Clinical trials for Immune Thrombocytopenia

Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP)

Start date: September 2015
Phase: Phase 3
Study type: Interventional

The objective is to evaluate the efficacy and safety of romiplostim for injection in adlut subjects with persistent or chronic primary immune thrombocytopenia (ITP).

NCT ID: NCT02868060 Completed - Clinical trials for Immune Thrombocytopenia (ITP)

Evaluating the Pharmacokinetics and Pharmacodynamics of Romiplostim in Patients With Immune Thrombocytopenia (ITP)

Start date: September 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of evaluating the pharmacokinetics and pharmacodynamics of romiplostim in patients with immune thrombocytopenia.

NCT ID: NCT02862353 Completed - Thrombocytopenia Clinical Trials

Thrombocytopenia Drug Immune Validation of New Biological Test Diagnostic

TITIM
Start date: October 25, 2017
Phase:
Study type: Observational

The drug immune thrombocytopenia (TIM) are the most common drug cytopenias. They result from a peripheral destruction of platelets in the presence of the drug only. They usually involve immunoglobulin G (IgG) directed against either the drug molecule bound to a carrier protein or, by autoimmunity, against a hidden epitope newly exposed as a result of treatment. The most common drugs involved are quinine, some antibiotics, nonsteroidal anti-inflammatory drugs or anticonvulsants but the list is not exhaustive. in the case of new-onset thrombocytopenia and after eliminating other possible causes, a TIM is suspected but the offending drug is difficult to identify in generally poly-medicated patients. Several drugs may be suspected and the clinician uses biology for rapid assistance to the "de-prescription" and reduces unnecessary therapeutic substitutions in an always difficult clinical situation. The Immunology Laboratory of the University Hospital of Saint-Etienne has developed a biological test of thrombocytopenia induction in the presence of the drug and the patient's serum that is to say its antibodies and complement fractions with cytometry reading flow. This Induction Test in vitro TIM (TITIM) is simple, fast, inexpensive, easy to transfer in hospital laboratories. But this test must be validated on well-documented clinical cases. The purpose of this pilot project is to validate the technical and assess the clinical specificity of the test TITIM for hard imputability drugs validated by a committee of experts combining a posteriori of clinical and biological criteria of routine.

NCT ID: NCT02859909 Completed - Clinical trials for Immune Thrombocytopenia

This Clinical Study is to Test Efficacy and Safety of BT595 in Chronic Primary Immune Thrombocytopenia (ITP)

Start date: November 2016
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to assess the efficacy and safety of BT595 in adult subjects with chronic ITP. The primary objective of this study is to determine the rate of subjects with a response. A response is defined as a platelet count of ≥30×10^9/L and at least a 2 fold increase of the baseline count, confirmed on at least 2 separate occasions at least 7 days apart, and the absence of bleeding. The secondary objectives of this study, in addition to further efficacy assessments, are to evaluate the safety of BT595.

NCT ID: NCT02858323 Completed - Thrombocytopenia Clinical Trials

Complement (C1q) Binding to HLA Antibodies in a Solid-phase Immunoassay and Clinical Effect on Platelet Transfusion

Start date: July 27, 2016
Phase:
Study type: Observational

Background: Platelets are blood cells that help blood clot. Some people have what is called thrombocytopenia. This means they have a low blood platelet count. They need platelet transfusions very often. Human leukocyte antigen (HLA) alloimmunization occurs for a lot of these people. They become refractory. This means their platelet levels no longer increase after transfusions. Researchers want to study a procedure that detects HLA antibodies. They want to test how well it predicts how a person will respond to a transfusion. They want to see if it does this better than the procedure that is usually used. Objective: To study the effect of C1q-binding of Class I HLA antibodies on platelet refractoriness in people who get platelet transfusions. To test if this method better predicts response to platelet transfusion than the IgG solid phase immunoassay method. Eligibility: People enrolled on protocols 11-C-0136, 08-H-0156, 03-C-0277, 01-C-0157, or 01-C-0129 who: Agreed to have their specimens and data used for future research Had Class I HLA antibodies detected by the IgG method Had one or more platelet transfusions at NIH after the first positive HLA IgG antibody result Design: For each participant, researchers will look at a small portion of their archived plasma sample. The samples were left over from prior HLA antibody tests. Participants samples will be analyzed. They will be tested to see if C1q-binding HLA antibodies are present. This will be done by solid phase immunoassay. Results will be compared with the past results of the IgG method. Participants data will be stored in database that s protected by password.

NCT ID: NCT02845609 Completed - Thrombocytopenia Clinical Trials

Efficacy of Sialic Acid GNE Related Thrombocytopenia

SA-thrombo
Start date: September 2016
Phase: Phase 2
Study type: Interventional

Sialic Acid-Extended Release (SA-ER, aceneuramic acid, UX001) is an extended release formulation of sialic acid (SA, also known as N-acetylneuraminic acid or NANA). The SA-ER is currently studied as a substrate replacement therapy for patients with GNE myopathy. The investigators plan to study the SA-ER compound in a cohort of five patients with GNE-related thrombocytopenia.