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Sickle Cell Disease clinical trials

View clinical trials related to Sickle Cell Disease.

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NCT ID: NCT03528434 Not yet recruiting - Sickle Cell Disease Clinical Trials

Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS)

ZIPS
Start date: June 1, 2018
Phase: Phase 3
Study type: Interventional

A randomized double-blinded placebo-controlled trial of zinc to reduce the incidence of severe or invasive infections in Ugandan children with sickle cell anemia (SCA).

NCT ID: NCT03513328 Not yet recruiting - Sickle Cell Disease Clinical Trials

Busulfan, Fludarabine, and Thiotepa Conditioning Regimen for Non Malignant Disease

Start date: June 2018
Phase: Phase 1/Phase 2
Study type: Interventional

In this study, the investigators test 2 dose levels of thiotepa (5 mg/kg and 10 mg/kg) added to the backbone of targeted reduced dose IV busulfan, fludarabine and rabbit anti-thymocyte globulin (rATG) to determine the minimum effective dose required for reliable engraftment for subjects undergoing hematopoietic stem cell transplantation for non-malignant disease.

NCT ID: NCT03492931 Recruiting - Sickle Cell Disease Clinical Trials

PK Study of Ticagrelor in Children Aged Less Than 24 Months, With Sickle Cell Disease (HESTIA4)

HESTIA4
Start date: March 28, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this Phase I study is to investigate the pharmacokinetic properties of ticagrelor in pediatric patients from 0 to less than 24 months with sickle cell disease. Ticagrelor dose level adjustment will require a Protocol amendment and regulatory approval

NCT ID: NCT03492099 Not yet recruiting - Sickle Cell Disease Clinical Trials

Assessing the Safety of Buprenorphine in People With Sickle Cell Disease

Start date: May 2018
Phase: Phase 2
Study type: Interventional

This study will assess the safety of changing pain medications (opioids) adult sickle cell patients take to another type of medication therapy (buprenorphine). Patients will be asked questions about their quality of life. Other tools for assessment will also be administered.

NCT ID: NCT03488264 Recruiting - Quality of Life Clinical Trials

Stigma, Self-management, & Quality of Life in SCD

SSQ
Start date: February 12, 2018
Phase:
Study type: Observational

Many individuals with sickle cell disease experience both a poor quality of life and stigma. Individuals with SCD often experience high levels of stigma which can be a barrier to good self-management and hinder quality of life. The purpose of this research is to improve understanding of the relationships between stigma, self-management, and quality of life in SCD in the United States and Jamaica. The findings from this project will contribute to the development of a tool to measure self-management strategies and will also guide the development of interventions to improve SCD self-management.

NCT ID: NCT03478917 Enrolling by invitation - Sickle Cell Disease Clinical Trials

Early Diagnosis of Sickle Acute Chest Syndrome Using a Combination of Plasma Bimarkers and Chest Imaging

Start date: May 25, 2018
Phase:
Study type: Observational

Background: Painful vasoocclusive crisis (VOC) occurs in people with sickle cell disease (SCD). People with VOC have many visits to the hospital. About 10 30 percent of these people will go on to develop acute chest syndrome (ACS). ACS can cause further ill health. It can also cause death. Researchers want to find ways to diagnose ACS more quickly. To do this, they want to use stored blood samples and scans from a study (the DeNOVO trial) that was closed in 2015. They want to see if scans and samples taken of people with VOC who later developed ACS could help diagnose ACS faster. The data of people in the DeNOVO study who did not develop ACS will serve as controls. Objectives: To look at data from the DeNOVO trial to find a way to diagnose ACS more quickly. Eligibility: People 10 85 years old who took part in NHLBI Protocol number 05-H-0019 (the DeNOVO trial). The trial lasted from 2004 to 2008. The study was closed in November 2015. Design: Scans and intact, frozen samples from a study that was closed in 2015 will be studied. No new participants will be enrolled.

NCT ID: NCT03474965 Not yet recruiting - Sickle Cell Disease Clinical Trials

Study of Dose Confirmation and Safety of Crizanlizumab in Pediatric Sickle Cell Disease Patients

Start date: August 30, 2018
Phase: Phase 2
Study type: Interventional

The purpose of the Phase 2 CSEG101B2201 study is to confirm and to establish appropriate dosing and to evaluate the safety in pediatric patients ages 6 months to <18 years with a history of VOC with or without HU/HC, receiving crizanlizumab for 2 years. The efficacy and safety of crizanlizumab was already demonstrated in adults with sickle cell disease. The approach is to extrapolate from the PK/pharmacodynamics (PD) already established in the adult population. The study is designed as a Phase II, multicenter, open-label study.

NCT ID: NCT03462511 Not yet recruiting - Sickle Cell Disease Clinical Trials

Hydroxyurea Adherence for Personal Best in Sickle Cell Disease (HABIT): Efficacy Trial

Start date: May 2018
Phase: N/A
Study type: Interventional

Many youth with chronic disease have difficulty taking medication every day and therefore do not receive full benefit from treatment. Sickle Cell Disease (SCD) is an inherited blood disease that affects African Americans and other underserved communities. Hydroxyurea (HU) is the sole FDA-approved drug therapy for SCD and is highly effective and improves quality of life. The proposed study, a 5-site four-year randomized control trial (RCT), builds upon the investigators' recent feasibility study of the same title. Overall goals are reducing barriers to HU use and improving adherence for youth 10-18 years through creation of a daily medication habit. The goal of the proposed multi-site study is to test the efficacy of the HABIT intervention at 6 months and sustainability of the effect at 12 months.

NCT ID: NCT03458897 Recruiting - Sickle Cell Disease Clinical Trials

Quantitative MRI for Patients With Sickle Cell Disease Undergoing Hematopoietic Cell Transplant

Start date: May 3, 2018
Phase: N/A
Study type: Interventional

The primary purpose of this research is to determine if it is feasible to perform serial magnetic resonance imaging (MRI) to evaluate the amount of bone marrow cells (also called cellularity) and iron stores before and after bone marrow transplantation for severe sickle cell disease.

NCT ID: NCT03431935 Recruiting - Sickle Cell Disease Clinical Trials

Predictors and Outcomes in Patients With Sickle Cell Disease

Start date: May 2018
Phase:
Study type: Observational

Children with sickle cell disease (SCD) are living longer with the advent of medical advances such as prophylactic penicillin, chronic transfusion, and hydroxyurea. Despite greater longevity in SCD, the period following the transition from pediatric to adult care is critical; youth aged 18-30 years are at high risk for mortality and have high rates of healthcare utilization, leading to high healthcare costs. As such, health care transition (HCT) programs have been created to prepare patients for adult-centered care and subsequently, improve health outcomes. However, very few programs have been evaluated for effectiveness in achieving optimal health outcomes in SCD. This paucity of program evaluation is attributed to a lack of identifiable predictors and outcomes. Researchers at St. Jude Children's Research Hospital want to identify factors and patterns of successful HCT. This information will be used to develop approaches to best evaluate HCT interventions and identify areas of improvement of HCT programming. PRIMARY OBJECTIVE: Describe hospital utilization, treatment adherence, and health-related quality of life in a cohort of patients with sickle cell disease (SCD) who will transfer to adult care during the study period. SECONDARY OBJECTIVE: Examine the associations between various factors and health care transition (HCT) outcomes.