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Anemia, Hemolytic clinical trials

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NCT ID: NCT04721262 Completed - Anemia, Hemolytic Clinical Trials

Ferumoxytol Enhanced Hyperfine Low Field Strength MRI

Start date: November 9, 2020
Phase:
Study type: Observational

The purpose of this pilot study is to evaluate the feasibility of using Ferumoxytol as a contrast agent on a low field strength, portable magnetic resonance imaging (MRI) system. Participants receiving Ferumoxytol as part of routine clinical care for iron deficiency anemia will be recruited and scanned on the Hyperfine MRI system before and after their clinically scheduled intravenous infusion. Resultant images will be compared to assess signal intensity changes generated by the presence of Feromoxytol.

NCT ID: NCT04691570 Completed - Clinical trials for Warm Autoimmune Hemolytic Anemia (wAIHA)

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANX005 in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)

Start date: November 10, 2021
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and tolerability of ANX005 in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).

NCT ID: NCT04269551 Completed - Clinical trials for Autoimmune Haemolytic Anaemia

A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease

Start date: June 15, 2020
Phase: Phase 1
Study type: Interventional

Primary Objective: To assess the safety and tolerability in participants with cold agglutinin disease (CAD), after a single dose of intravenous (IV) BIVV020 Secondary Objectives: To assess, in participants with cold agglutinin disease, after a single dose of intravenous (IV) BIVV020: - The effect of BIVV020 on complement mediated hemolysis - The pharmacodynamics (PD) of BIVV020 relating to complement inhibition - The pharmacokinetics (PK) of BIVV020 - The immunogenicity of BIVV020

NCT ID: NCT04083014 Completed - Clinical trials for Autoimmune Hemolytic Anemia

Single-dose Anti-CD20 Antibody With Bortezomib for Relapsed Refractory Autoimmune Hemolytic Anemia

RRAIHA01
Start date: August 20, 2019
Phase: Phase 2
Study type: Interventional

Patients of relapsed and refractory warm autoimmune hemolytic anemia or EVANS syndrome aged 18 to 80 will be included in this study. The treatment regimen is a single dose anti-CD20 antibody (500mg) combined with bortezomib (1.3mg/m2 twice a week for two weeks). The treatment course would be repeated three months later.

NCT ID: NCT04057703 Completed - Immunotherapy Clinical Trials

Balance Benefit / Risk of Immunomodulatory Treatments at the Child and Adolescent for Autoimmune Cytopenia.

VIGICAIRE
Start date: January 18, 2016
Phase:
Study type: Observational

In France, a national prospective cohort for monitoring children and adolescents with autoimmune cytopenia OBS'CEREVANCE is in place since 2004. It is coordinated in Bordeaux by the Center's team. Reference Rare Diseases CEREVANCE. It has been validated by the French Data Protection Authority in 2009 (information note and written consent). It had mid 2013 more of 900 patients, and the data collected make it possible to study intentionally to treat the therapeutic management of patients with Chronic Immune-Thrombocytopenic Purpura, from Autoimmune Hemolytic Anemia, or from EVANS syndrome. This study evaluates efficacy and tolerance at 6 months of treatment immunomodulators prescribed in France in real conditions of use, in children and adolescents under the age of 18, for a Chronic Immune-Thrombocytopenic Purpura, an Autoimmune Hemolytic Anemia or a simultaneous EVANS syndrome.

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: NCT03559699 Completed - Clinical trials for Pyruvate Kinase Deficiency

A Study Evaluating the Efficacy and Safety of AG-348 in Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD)

Start date: June 26, 2018
Phase: Phase 3
Study type: Interventional

Study AG348-C-007 was a multicenter study designed to evaluate the efficacy and safety of treatment with AG-348 in a minimum of 20, with up to 40, participants with pyruvate kinase (PK) deficiency, who were regularly receiving blood transfusions. The study was composed of two parts. During Part 1, Dose Optimization Period, participants started on a dose of 5 mg AG-348 administered twice daily. Over the course of Part 1 each participant's dose of AG-348 was sequentially increased to 20 mg twice a day, followed by 50 mg twice a day depending on their tolerance. During Part 2, Fixed-Dose Period, participants received AG-348 at their optimized dose from Part 1.

NCT ID: NCT03548220 Completed - Clinical trials for Pyruvate Kinase Deficiency

A Study to Evaluate Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD)

Start date: August 9, 2018
Phase: Phase 3
Study type: Interventional

Study AG348-C-006 evaluated the efficacy and safety of orally administered AG-348 as compared with placebo in participants with pyruvate kinase (PK) deficiency, who were not regularly receiving blood transfusions. Participants were randomized 1:1 to receive either AG-348 or a matching placebo.

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: 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.