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Anemia, Sickle Cell clinical trials

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NCT ID: NCT05045820 Recruiting - Pain Clinical Trials

Integrative Medicine in Pain Management in Sickle Cell Disease

Start date: June 29, 2021
Phase: N/A
Study type: Interventional

The proposed research is to determine the clinical efficacy and neurobiological mechanisms of acupuncture analgesia in patients with sickle cell disease.

NCT ID: NCT05033314 Recruiting - Sickle Cell Disease Clinical Trials

THromboprophylaxis In Sickle Cell Disease With Central Venous Catheters (THIS)

THIS
Start date: June 7, 2022
Phase: Phase 3
Study type: Interventional

Research Question: In adult SCD patients with CVC, is it feasible and safe to conduct an adequately powered RCT to evaluate the use of rivaroxaban as thromboprophylaxis in this population? Study Design: The study is a vanguard pilot double blind multi-centre randomized controlled trial. Participants with SCD and CVC will be randomized to either rivaroxaban 10mg PO daily or placebo for the duration of CVC in situ or for up to one year, whichever is less. After screening (day -7 to day -1), patients will be followed at day 1, months 3 (+/- 15 days), 6 (+/- 15 days), 9 (+/- 15 days), and 12 (+/- 15 days). Study Objectives: The primary objective is to estimate the proportion of eligible patients who will enroll into a trial of thromboprophylaxis. Secondary objectives include (a) document indications for central venous catheter (CVC), (b) summarize duration of CVC insertion prior to enrollment, (c) estimate adherence to the study drug, (d) estimate proportions of participants being compliant with study procedures, and lost to follow up. Exploratory objectives will assess thrombotic, bleeding, and quality of life outcomes.

NCT ID: NCT05031780 Recruiting - Sickle Cell Disease Clinical Trials

A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP)

Start date: February 11, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This clinical trial is a Phase 2/3 study that will determine the recommended dose of mitapivat and evaluate the efficacy and safety of mitapivat in sickle cell disease by testing how well mitapivat works compared to placebo to increase the amount of hemoglobin in the blood and to reduce or prevent the occurrence of sickle cell pain crises. In addition, the long-term effect of mitapivat on efficacy and safety will be explored in an open-label extension portion.

NCT ID: NCT05018728 Recruiting - Clinical trials for Sickle Cell Anemia in Children

The Effect of Voxelotor on Cerebral Hemodynamic Response in Children With Sickle Cell Anemia

VoxSCAN
Start date: March 28, 2022
Phase: Phase 2
Study type: Interventional

Voxelotor is a new drug for adolescents and adults with sickle cell disease that improves hemoglobin levels and reduces the incidence of worsening anemia. However, it is unclear whether this increase in hemoglobin is associated with a reduction in cerebral metabolic stress. This study will measure the effects of voxelotor on cerebral hemodynamics.

NCT ID: NCT05012631 Recruiting - Sickle Cell Disease Clinical Trials

Losartan for Diffuse Myocardial Fibrosis in Sickle Cell Disease

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

This study is a pilot, phase II, open-label study of the angiotensin II receptor blocker, losartan, in patients with Sickle Cell Disease (SCD) 6 years or older for 12 months. The investigators will enroll 24 patients with SCD over the course of 1 year with a goal to complete all study procedures in 2 years. The short-term goal is to obtain clinical pilot data regarding the safety and efficacy of losartan in stabilizing or decreasing extracellular volume fraction (ECV) after 12 months of therapy.

NCT ID: NCT04987489 Recruiting - Sickle Cell Disease Clinical Trials

A Study of Etavopivat in Patients With Thalassemia or Sickle Cell Disease

Start date: December 1, 2021
Phase: Phase 2
Study type: Interventional

This clinical trial is a Phase 2 study that will evaluate the safety and clinical activity of etavopivat in patients with thalassemia or sickle cell disease and test how well etavopivat works to lower the number of red blood cell transfusions required and increase hemoglobin.

NCT ID: NCT04930445 Recruiting - Sickle Cell Disease Clinical Trials

Oxbryta® Product Registry An Observational Study Designed to Evaluate the Effect of Oxbryta in Individuals With SCD

PROSPECT
Start date: November 12, 2021
Phase:
Study type: Observational [Patient Registry]

This registry is an observational study designed to evaluate the effect of Oxbryta in individuals with SCD in a real-world setting.

NCT ID: NCT04925492 Recruiting - Sickle Cell Disease Clinical Trials

PET Imaging of Vaso-Occlusive Crisis (VOC) in SCD

Start date: November 11, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to find objective biomarkers of vaso-occlusion (blood vessel blockage) in people with SCD. Using information from earlier studies and work being done, researchers have developed a strategy to image VOC, using positron emission tomography (PET). The ability to see and measure VOC in SCD patients can help patient care, by showing when and how a VOC is occurring or going to occur. Studying this method will also help in future drug research, as it will allow researchers to deliver promising new medications that target hyper-adhesion and sickling in people with SCD.

NCT ID: NCT04917120 Recruiting - Sickle Cell Disease Clinical Trials

Observational Prospective Study Measuring the Impact of the Use of a Hypnotic Script Associated With Virtual Reality on the Pain of the Child's Sickle Cell During a Vaso-occlusive Crisis

DREPAReV
Start date: July 13, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effect of Virtual Reality induced Hypnosis on patients' pain scores, anxiety and the use of analgesics during a vaso-occlusive crisis

NCT ID: NCT04912869 Recruiting - Sickle Cell Disease Clinical Trials

A Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOE) in Participants With Sickle Cell Disease (SCD).

CROSSWALK-a
Start date: March 26, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate crovalimab for the treatment of a sickle cell pain crisis (also known as a VOE) that requires hospitalisation in adult and adolescent participants with SCD. The primary objective of this study is safety and will additionally evaluate pharmacokinetics (how crovalimab is processed by your body), pharmacodynamics (how your body reacts to crovalimab) and the preliminary efficacy of crovalimab compared with placebo.