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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: NCT06274203 Completed - Sickle Cell Disease Clinical Trials

High Dose Vitamin D Supplementation in Children With Sickle Cell Disease

Start date: May 3, 2023
Phase: N/A
Study type: Interventional

Suboptimal vitamin D status is well reported in sickle cell disease (SCD) patients and associated with a negative impact on health-related quality of life (HRQL). The investigators enrolled 42 SCD patients and 42 healthy controls, subjects within each group received monthly oral vitamin D3 dose according to the baseline status of vitamin D as follows: sufficient: 100,000 IU, insufficient: 150,000 IU, and deficient: 200,000 IU. The investigators assessed safety and efficacy on normalization of vitamin D level, bone mineral density (BMD), hand grip strength (HGS), and HRQL.

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: NCT06213402 Recruiting - Sickle Cell Disease Clinical Trials

RADeep Multicenter European Epidemiological Platform for Patients Diagnosed With Rare Anemia Disorders (RADs)

RADeep
Start date: November 30, 2021
Phase:
Study type: Observational [Patient Registry]

Rare Anaemia Disorders (RADs) is a group of rare diseases characterized for presenting anaemia as the main clinical manifestation. Different medical entities classified as RADs by ORPHA classification are most of them chronic life threating disorders with many unmet needs for their proper clinical management creating an impact on European health systems. RADs present diagnostic challenges and their appropriate management requires from specialised multidisciplinary teams in Centers of expertise. Although there are some examples of well-established national registries on RADs in EU, the lack of recommendations for Rare disease registries implementation and the lack of standards for interoperability has led to the fragmentation or unavailability of data on prevalence, survival, main clinical manifestations or treatments in most of the European countries.

NCT ID: NCT06198712 Recruiting - Sickle Cell Disease Clinical Trials

A Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease

Start date: February 7, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This study is being done to learn about etavopivat, a once a day medicine taken by mouth in adolescents with sickle cell disease. The main goals are to study safety and how long etavopivat stays in the bloodstream, while also studying if there are benefits from taking etavopivat. Eligible participants who enter the study will start a 96-week treatment period. At the end of the 96 weeks, participants will have an end of study visit that occurs 4 weeks later. The participants will receive etavopivat every day throughout the treatment period.

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: NCT06171217 Recruiting - Sickle Cell Disease Clinical Trials

Realizing Effectiveness Across Continents With Hydroxyurea

REACH
Start date: October 27, 2023
Phase: Phase 2
Study type: Interventional

REACH is a prospective, phase I/II open-label dose escalation trial of hydroxyurea for children with confirmed SCA between 3 and 10 years of age. The short-term goal is to obtain critical pilot data regarding the feasibility, safety, and benefit of hydroxyurea for children with SCA in multiple distinct research settings in Africa. Based on that information, the longer-term goal is to make hydroxyurea more widely available for children with SCA in Africa, particularly those identified with SCA through expanded newborn screening programs.