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Sickle Cell Disease clinical trials

View clinical trials related to Sickle Cell Disease.

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NCT ID: NCT06287086 Not yet recruiting - Sickle Cell Disease Clinical Trials

Clinical Study on the Safety and Efficacy of BRL-101 in the Treatment of Sickle Cell Disease

Start date: June 14, 2024
Phase: N/A
Study type: Interventional

This is a single center, non-randomized, open label, single-dose study in subjects with Sickle Cell Disease (SCD). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (BRL-101)

NCT ID: NCT06286046 Not yet recruiting - Sickle Cell Disease Clinical Trials

A Study of Mitapivat in Participants With Sickle Cell Disease and Nephropathy

Start date: June 2024
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to evaluate the effect of mitapivat on albumin creatinine ratio (ACR) response in participants with sickle cell disease (SCD) and nephropathy.

NCT ID: NCT06264700 Not yet recruiting - Sickle Cell Disease Clinical Trials

Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness

ADHERE
Start date: March 2024
Phase: N/A
Study type: Interventional

This study is for caregivers of young children with sickle cell disease and adolescents with sickle cell disease who are currently prescribed hydroxyurea and are receiving care at one of the study sites. The study will assess retention and engagement during a pilot randomized control trial comparing video directly observed therapy (VDOT) to attention control. We also hope to understand more about patient and family preferences longer-term adherence monitoring and intervention. Participants will use an electronic adherence monitor (provided by the study team) to measure how often they are taking their hydroxyurea. Participants will also be asked to complete questionnaires throughout the study period to provide information about their expectations for, experience with, and satisfaction with the study materials.

NCT ID: NCT06260891 Not yet recruiting - Sickle Cell Disease Clinical Trials

Zinc Supplementation in Sickle Cell Disease

ZnSCD
Start date: April 1, 2025
Phase: Phase 2
Study type: Interventional

The goal of this short term prospective Phase II study is to compare the effects of two alternate daily doses of zinc (25 and 40 mg/day) in 34 randomly assigned homozygous Sickle Cell Disease (SCD-SS) patients aged 15-35 years old. The main question it aims to answer is: Which biomarkers are most responsive to zinc supplementation, and what is the maximum tolerated zinc dose that induces the desired changes in biomarkers of bone turnover? Participants will be recruited from 7 American Society Hematology Research Collaborative SCD Centers. Eligible SCD subjects will be invited to participate in the 16-week study, involving 2 baseline blood draws 4 weeks apart, followed by a 12-week zinc intervention. The findings from this study will be used to determine the dosage of zinc to be used in a larger, future study on the long term impact of zinc supplementation on bone health in SCD-SS.

NCT ID: NCT06251843 Not yet recruiting - Sickle Cell Disease Clinical Trials

Support Strategies for Parents During the First Year Following Their Child's Diagnosis of Sickle Cell Disorder

Start date: May 2024
Phase:
Study type: Observational

Background: Sickle cell disorder (SCD), the commonest genetic (faulty gene inherited from both parents) condition in the UK, affects mainly underserved groups. Babies with SCD must start treatments soon after birth to prevent them becoming unwell. Stigma, fear and inequalities can make it difficult for parents to accept their child's diagnosis and access appropriate treatment and support. Aim: Develop strategies to improve support for parents during their child's first year of life following a SCD diagnosis to encourage early engagement with health services. Method: Comprises two stages: (i) Determine why parents choose to engage with support or not (ii) Use this information to co-design strategies to ensure greater accessibility of support for parents during their child's first year of life. Patient and Public Involvement: We are working with Sickle Cell Society and parents of children with SCD. Dissemination: Findings will be shared with support groups, charities, health professionals and academics.

NCT ID: NCT06184126 Not yet recruiting - Sickle Cell Disease Clinical Trials

Virtual Reality Devices as an Adjunct to Usual Care for Patients With Sickle Cell Disease Experiencing Vaso-Occlusive Crises

Start date: June 2024
Phase: N/A
Study type: Interventional

This study aims to evaluate the use of virtual reality as an adjunct to standard care for patients with sickle cell disease experiencing vaso-occlusive crises.

NCT ID: NCT06147414 Not yet recruiting - Cystic Fibrosis Clinical Trials

Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders

DANNIgene
Start date: April 2024
Phase:
Study type: Observational

Cell-free fetal DNA (cffDNA) is present in the maternal blood from the early first trimester of gestation and makes up 5%-20% of the total circulating cell-free DNA (cfDNA) in maternal plasma. Its presence in maternal plasma has allowed development of noninvasive prenatal diagnosis for single-gene disorders (SGD-NIPD). This can be performed from 9 weeks of amenorrhea and offers an early, safe and accurate definitive diagnosis without the miscarriage risk associated with invasive procedures. One of the major difficulties is distinguishing fetal genotype in the high background of maternal cfDNA, which leads to several technical and analytical challenges. Besides, unlike noninvasive prenatal testing for aneuploidy, NIPD for monogenic diseases represent a smaller market opportunity, and many cases must be provided on a bespoke, patient- or disease-specific basis. As a result, implementation of SGD-NIPD remained sparse, with most testing being delivered in a research setting. The present project aims to take advantage of the unique French collaborative network to make SGD-NIPD possible for theoretically any monogenic disorder and any family.

NCT ID: NCT06139510 Not yet recruiting - Chronic Pain Clinical Trials

Predictors of Pain in Sickle Cell Disease

Start date: April 2024
Phase: N/A
Study type: Interventional

Sickle cell disease is a painful inherited disorder that affects approximately 100,000 people in the United States, and more than half of these individuals develop chronic or persistent pain that is often severe and disabling. The factors that predict whether an individual with sickle cell disease will develop severe, disabling pain are unclear. The goal of this project is to identify the factors that predict severe pain outcomes in individuals living with sickle cell disease in order to improve pain management strategies and guide future studies of non-opioid therapies for treatment of their pain. Participants who agree to enroll in this study will be asked to participate in a virtual and then an in-person study visit for their full initial study assessment. They will answer survey questions during the virtual visit, and will be asked to complete several types of standard testing to understand how their body handles pain during the in-person visit. After completing the virtual and in-person sessions, participants will receive text or electronic medical record messages with brief survey (will take less than 8 minutes to complete) on their pain experiences every three months until the study is completed (or up to 48 months for people who are enrolled at the beginning of the study).

NCT ID: NCT06016634 Not yet recruiting - Sickle Cell Disease Clinical Trials

Alendronate for Osteonecrosis in Adults With Sickle Cell Disease

Start date: March 2024
Phase: Phase 2
Study type: Interventional

A prospective, single-arm, intervention study of oral alendronate in adults with sickle cell disease and osteonecrosis

NCT ID: NCT05951205 Not yet recruiting - Sickle Cell Disease Clinical Trials

Evaluation of Efficacy and Safety of a Single Dose of Exa-cel in Participants With Severe Sickle Cell Disease, βS/βC Genotype

Start date: April 2024
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy and safety of CTX001 (exa-cel) in adolescent and adult participants with severe sickle cell disease (SCD), βS/βC genotype (HbSC).