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Anemia, Hemolytic, Autoimmune clinical trials

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NCT ID: NCT03764618 Completed - Clinical trials for Warm Antibody Autoimmune Hemolytic Anemia

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA

Start date: April 24, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the efficacy of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).

NCT ID: NCT03576742 Active, not recruiting - Clinical trials for Immune Thrombocytopenia

Severe Immune Cytopenia Registry Www.Sic-reg.Org

sic-reg
Start date: March 9, 2018
Phase:
Study type: Observational [Patient Registry]

Prospective registry study for children and young adults with severe immune cytopenias (persisting/chronic immune thrombocytopenia, autoimmune hemolytic anemia, and Evans syndrome) to improve the management, facilitate the differential diagnostic work-up, and document the clinical course under various treatments. Time points: at inclusion, after 6 months, after 12 months, then yearly up to 4 years after inclusion. No intervention, mere observation and documentation. Guided pre-inclusion (differential) diagnostic work-up.

NCT ID: NCT03538041 Completed - Clinical trials for Autoimmune Hemolytic Anemia

A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia

Start date: November 21, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of parsaclisib administered orally to participants with autoimmune hemolytic anemia (AIHA) who have decreased hemoglobin and evidence of ongoing hemolysis that requires treatment intervention.

NCT ID: NCT03347422 Completed - Clinical trials for Cold Agglutinin Disease

A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion

Cadenza
Start date: March 17, 2018
Phase: Phase 3
Study type: Interventional

The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (>=)1.5 grams per deciliter (g/dL) increase in hemoglobin (Hgb) level and avoidance of transfusion in participants with primary cold agglutinin disease (CAD) without a recent history of blood transfusion. The purpose of Part B was to evaluate the long-term safety and tolerability of sutimlimab in participants with primary CAD.

NCT ID: NCT03347396 Completed - Clinical trials for Agglutinin Disease, Cold

A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)

Start date: March 5, 2018
Phase: Phase 3
Study type: Interventional

The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (>=) 2 grams per deciliter (g/dL) increase in hemoglobin (Hgb) levels or increased Hgb to >= 12 g/dL and obviated the need for blood transfusion during treatment in participants with primary cold agglutinin disease (CAD) who had a recent history of blood transfusion. The purpose of Part B was to evaluate the long-term safety and tolerability of sutimlimab in participants with CAD.

NCT ID: NCT03269292 Completed - Clinical trials for Autoimmune Hemolytic Anemia

Clinical Characteristics and Treatment Outcomes of Patients With Autoimmune Hemolytic Anemia

Start date: October 1, 2017
Phase:
Study type: Observational

Autoimmune hemolytic anemia is characterized by shortened red blood cell survival and a positive Coombs test. The responsible autoantibodies may be either warm reactive or cold reactive. The rate of hemolysis and the severity of the anemia may vary from mild to severe and life-threatening. Diagnosis is made in the laboratory by the findings of anemia, reticulocytosis, a positive Coombs test, and specific serologic tests. The prognosis is generally good but renal failure and death sometimes occur, especially in cases mediated by drugs.

NCT ID: NCT03226678 Completed - Clinical trials for Warm Autoimmune Hemolytic Anemia

Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)

Start date: August 31, 2017
Phase: Phase 2
Study type: Interventional

This study is to assess the safety, tolerability, preliminary efficacy, and pharmacokinetics of APL-2 in subjects with warm Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD).

NCT ID: NCT03075878 Terminated - Clinical trials for Warm Autoimmune Hemolytic Anemia

A Safety Study of SYNT001 in Participants With Warm Autoimmune Hemolytic Anemia (WAIHA)

Start date: January 10, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This main study objective was to evaluate the safety and tolerability of intravenous (IV) SYNT001 (ALXN1830) in participants with WAIHA.

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: NCT02828670 Recruiting - Clinical trials for Autoimmune Hemolytic Anemia

Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)

TFH and AIHA
Start date: June 7, 2016
Phase:
Study type: Observational

T follicular helper (TFH) cells represent a T cell subset dedicated to the activation of B cells. They have been involved in the pathogenesis of autoimmune diseases in humans such as lupus and Sjögren disease. We recently showed that TFH are implicated in the activation of autoreactive B lymphocytes during ITP. Autoimmune hemolytic anemia (AIHA) is an autoimmune disease due to antibodies targeting red blood cells. To date, the role of TFH in the pathogenesis of AIHA is not known. We hypothesize that AIHA is associated with an increase in the number and/or function of TFH, that could participate in the activation of autoreactive B lymphocytes.