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Anemia, Sickle Cell clinical trials

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NCT ID: NCT06300723 Not yet recruiting - Sickle Cell Disease Clinical Trials

Clinical Study of BRL-101 in Severe SCD

Start date: September 25, 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: NCT06296654 Completed - Self-Efficacy Clinical Trials

Effect of Empowerment-Based Interventions on Self-Efficacy and Self-Care Capacity Among Adults With Sickle Cell Disease

Start date: March 20, 2022
Phase: N/A
Study type: Interventional

This study aimed to To investigate the effect of empowerment-based interventions (EBI) on self-efficacy and self-care capacity among adults with Sickle Cell Disease (SCD). The hypotheses of this study were: Adults with SCD who receive EBI exhibit higher self-efficacy, self- management capacity and HRQoL than those who do not.

NCT ID: NCT06293222 Active, not recruiting - Sickle Cell Disease Clinical Trials

Patient and Public Involvement and Engagement in Research With Children and Young People With Sickle Cell Disorder and Their Families

Start date: August 21, 2023
Phase:
Study type: Observational

Aim: To co-produce resources for inclusive and equitable Patient and Public Involvement and Engagement in research on life-limiting conditions, with children and young people with sickle cell disorder and their families. Methods: Workshops with a) members of a patient advocacy organisation (Sickle Cell Society n=5) b): i) Children and young people (10-18 years) with sickle cell disorder (n=15) and ii) their siblings (10-18 years, n=10) and iii) their parents (n=15), c) Researchers form the Cicely Saunders Institute Outputs: Resources that enable children and young people with sickle cell disorder and their families to engage in research

NCT ID: NCT06290401 Not yet recruiting - Anemia, Sickle Cell Clinical Trials

A Socio-ecological Approach for Improving Self-management in Adolescents With SCD

SC-Thrive
Start date: November 30, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the impact of SCThrive (a behavioral self-management intervention) on patient activation, self-management behaviors, daily functioning, and emergency room visits in 260 adolescents and young adults with sickle cell disease (SCD) ages 13-21 receiving care at 1 of 4 pediatric SCD clinics. The main question[s]it aims to answer are: - Does SCThrive improve patient activation? - Does SCThrive improve self-management behaviors, daily functioning, and decrease emergency room visits? - Are any improvements maintained 3 months after treatment? Participants will complete self-management related surveys before, after, and 3 months following their participation in an 8- week, virtual group intervention with an accompanying mobile app (SCThrive). Researchers will compare outcomes for participants who receive SCThrive and participants who receive uniform standard care (SCHealthED which = standard of care plus SCD educational text messages) to see if there are differences in patient activation, self-management behaviors, daily functioning, and emergency room visits.

NCT ID: NCT06287099 Not yet recruiting - Sickle Cell Disease Clinical Trials

Clinical Study of BRL-101 in the Treatment of Sickle Cell Disease

Start date: April 20, 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: 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.