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Anemia, Hemolytic clinical trials

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NCT ID: NCT04814394 Not yet recruiting - Clinical trials for Autoimmune Hemolytic Anemia

The Significance of Release of T-follicular Helper and T-follicular Regulatory Cells in Autoimmune Haemolytic Anemia Before and After Tratment

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Start date: April 1, 2022
Phase:
Study type: Observational

we study the circulating T-follicular regulatory and T-follicular regulatory cells in autoimmune hemolytic anemia.

NCT ID: NCT04802057 Active, not recruiting - Clinical trials for Autoimmune Haemolytic Anaemia

Safety and Tolerability Study in Adults With Cold Agglutinin Disease Previously Treated With SAR445088 or Never Treated With SAR445088

Start date: March 22, 2021
Phase: Phase 1
Study type: Interventional

Primary Objective: To assess the long-term safety and tolerability in patients with cold agglutinin disease (CAD), after multiple doses of SAR445088 Secondary Objective: To assess, in patients with cold agglutinin disease (CAD), after multiple doses of SAR445088: - The long-term effect of SAR445088 on complement mediated hemolysis - The long-term pharmacodynamics (PD) effect of SAR445088 relating to complement inhibition - The long-term pharmacokinetic (PK) profile of SAR445088 - The long-term immunogenicity of SAR445088

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: NCT04661033 Terminated - Clinical trials for Warm Autoimmune Hemolytic Anemia (wAIHA)

Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia (wAIHA)

Start date: September 9, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Primary Objectives: - Part A: To evaluate the safety and tolerability of subcutaneous injections of isatuximab in adults with wAIHA - Part B: To evaluate the efficacy of the selected dose in adults with wAIHA Secondary Objectives: - Part A (Cohorts 2 and 3 only) - To evaluate the efficacy of isatuximab in adults with wAIHA - To evaluate the durability of response to isatuximab and time to response - To evaluate the impact of isatuximab treatment on fatigue Part B - To evaluate the safety and tolerability of isatuximab in adults with wAIHA - To evaluate the durability of response to isatuximab and time to response - To evaluate the impact of isatuximab treatment on fatigue Parts A (all Cohorts) and B - To evaluate the effect of isatuximab on markers of hemolysis - To characterize the pharmacokinetic profile of isatuximab in adults with wAIHA - To evaluate the immunogenicity of isatuximab

NCT ID: NCT04657094 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia

Start date: March 16, 2021
Phase: Phase 2
Study type: Interventional

This phase II trial studies the effect of acalabrutinib in treating autoimmune hemolytic anemia that has come back (relapsed) or has not responded to previous treatment (refractory) in patients with chronic lymphocytic leukemia. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT04610866 Active, not recruiting - Sickle Cell Disease Clinical Trials

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat

Start date: December 9, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Sickle cell disease (SCD) is a disorder that causes episodes of acute pain and progressive organ damage. Ways to manage SCD have evolved slowly. Treatments do not always work. Researchers want to see if a drug called mitapivat can help people with SCD. Objective: To test the long-term tolerability and safety of mitapivat (or AG-348) in people with SCD. Eligibility: Adults age 18-70 with SCD who took part in and benefited from NIH study #19H0097. Design: Participants will be screened with a medical history and physical exam. They will give a blood sample. They will have an electrocardiogram to test heart function. Participants will repeat some of the screening tests during the study. Participants will complete 6-minute walk tests to measure mobility and function. They will have transthoracic echocardiograms to measure heart and lung function. They will have dual-energy X-ray absorptiometry scans to measure bone health. They will complete online questionnaires that measure their overall health and well-being. Participants will take the study drug in the form of a tablet twice a day. Participants will keep a study diary. They will record any symptoms they may have. Participation will last for about 54 weeks. After 48 weeks, participants can either keep taking the study drug for 48 more weeks or be tapered off of the study drug to complete the study. Those who are on the study for 1 year will have 10 study visits. Those who are on the study for 2 years will have 14 study visits.

NCT ID: NCT04398459 Recruiting - Clinical trials for Refractory/Relapsed Autoimmune Hemolytic Anemia

The Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia

Start date: May 1, 2020
Phase: Phase 2
Study type: Interventional

This is an open-label, single-arm study to evaluate the safety and efficacy of Ibrutinib in subjects with refractory/relapsed autoimmune hemolytic anemia.

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: NCT04256148 Withdrawn - Clinical trials for Warm Autoimmune Hemolytic Anemia

ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia

Start date: July 2021
Phase: Phase 2
Study type: Interventional

The main objective of the study is to evaluate the safety and efficacy of ALXN1830 compared to placebo in adult participants with warm autoimmune hemolytic anemia (WAIHA).