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Sickle Cell Disease clinical trials

View clinical trials related to Sickle Cell Disease.

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NCT ID: NCT04053803 Active, not recruiting - Sickle Cell Disease Clinical Trials

An Extension Study of IMR-687 in Adult Patients With Sickle Cell Anemia

Start date: May 22, 2019
Phase: Phase 2
Study type: Interventional

This is an open-label extension study of IMR-687 in adult patients who completed Imara's blinded Phase 2a study (IMR-SCD-102). The open-label extension study will evaluate long-term safety and tolerability.

NCT ID: NCT03989986 Active, not recruiting - Sickle Cell Disease Clinical Trials

iPeer2Peer Program for Youth With Sickle Cell Disease

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

The iPeer2Peer Sickle Cell Disease (SCD) study matches youth (12-18 years of age) with SCD to a mentor (trained young adult) who has learned to manage their SCD well, transitioned to adult care, and can support youth participants emotionally and socially. Participants will be randomly assigned one of two groups, either (1) The intervention group: Study group participants are matched with a mentor for 15 weeks, and are expected to have up to ten calls with one another; (2) The control group: This study group will be on a 15 week waitlist to receive a mentor. This study will first assess the feasibility of conducting this research with youth with SCD. Also, this study will assess the preliminary effectiveness of peer mentorship by comparing various health outcomes of the two study groups post-intervention.

NCT ID: NCT03964792 Active, not recruiting - Sickle Cell Disease Clinical Trials

Safety and Efficacy of Gene Therapy of the Sickle Cell Disease by Transplantation of an Autologous CD34+ Enriched Cell Fraction That Contains CD34+ Cells Transduced ex Vivo With the GLOBE1 Lentiviral Vector Expressing the βAS3 Globin Gene in Patients With Sickle Cell Disease (DREPAGLOBE)

DREPAGLOBE
Start date: November 12, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the Safety and Efficacy of Gene Therapy of the Sickle Cell disease by Transplantation of an Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced ex vivo with the GLOBE1 lentiviral vector expressing the βAS3 globin gene (GLOBE1 βAS3 Modified Autologous CD34+ Cells) in Patients with Sickle Cell Disease (SCD)

NCT ID: NCT03938324 Active, not recruiting - Cystic Fibrosis Clinical Trials

Peer i-Coaching for Activated Self-Management Optimization in Adolescents and Young Adults With Chronic Conditions

PiCASO
Start date: October 29, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to test the efficacy of a peer support coaching intervention to improve activated chronic illness self-management versus an attention control group in 225 adolescents and young adults with childhood onset chronic conditions.

NCT ID: NCT03904134 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation (BMT CTN 1702)

BMT CTN 1702
Start date: June 14, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if a search strategy of searching for an HLA-matched unrelated donor for allogeneic transplantation if possible then an alternative donor if an HLA-matched unrelated donor is not available versus proceeding directly to an alternative donor transplant will result in better survival for allogeneic transplant recipients within 2 years after study enrollment.

NCT ID: NCT03745287 Active, not recruiting - Sickle Cell Disease Clinical Trials

A Safety and Efficacy Study Evaluating CTX001 in Subjects With Severe Sickle Cell Disease

Start date: November 27, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This is a single-arm, open-label, multi-site, single-dose Phase 1/2/3 study in subjects with severe 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) using CTX001.

NCT ID: NCT03708731 Active, not recruiting - Sickle Cell Disease Clinical Trials

Exploring Adherence Monitoring in Sickle Cell Disease

Start date: March 12, 2019
Phase:
Study type: Observational

Despite the well-documented benefits of hydroxyurea (HU) therapy in decreasing morbidity and mortality in youth with Sickle cell disease (SCD), pediatric HU adherence rates range as low as 49% and lead to discontinuation of HU regimens in 8-20%. In addition, treatment non-adherence may lead to unnecessary increases in medication dosage resulting from erroneous assumption that a patient is non-responsive to treatment (versus non-adherent to the regimen as prescribed). Given the detrimental effects of non-adherence, assessment of and intervention for HU non-adherence is essential to improving health outcomes in the pediatric SCD population. Electronic adherence monitoring is widely considered the "gold standard" in objective adherence measurement. These monitors provide continuous, real- time records of medication adherence and reveal problematic behavior patterns, including underdosing, overdosing, delayed dosing, "drug holidays," and "white coat" adherence. Overall, electronic adherence measures are considered valid, reliable, and accurate, with clear advantages over pharmacy refill records, physician estimates and self-report measures. The primary purpose of this pilot study is to determine the use of the AdhereTech as a feasible and valid measure of HU adherence in pediatric SCD. Primary Objective Estimate the association between HU adherence as measured by the AdhereTech device to a) caregiver-report, b) youth-report, c) lab values, d) pill- count, and e) Medication Possession Ratio (MPR) adherence measures Secondary Objectives Estimate the rate of consent to the study, the rate of AdhereTech device use, the rate of AdhereTech device failure, and the perceived acceptability of using the AdhereTech device, as reported by caregivers and youth

NCT ID: NCT03653247 Active, not recruiting - Sickle Cell Disease Clinical Trials

A Study to Assess the Safety, Tolerability, and Efficacy of BIVV003 for Autologous Hematopoietic Stem Cell Transplantation in Patients With Severe Sickle Cell Disease

Start date: March 6, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open label, multicenter, Phase 1/2 study in approximately eight adults with severe Sickle Cell Disease (SCD). The study will evaluate the safety, tolerability, and efficacy of autologous hematopoietic stem cell transplantation using BIVV003.

NCT ID: NCT03648710 Active, not recruiting - Sickle Cell Disease Clinical Trials

Community Health Workers and mHealth for Sickle Cell Disease Care

Start date: January 15, 2019
Phase: N/A
Study type: Interventional

This study will compare the effectiveness of two self-management support interventions-Community Health Workers (CHW) and mobile health (mHealth)-versus enhanced usual care to improve health-related quality of life and acute care use for transitioning youth with sickle cell disease (SCD), and identify and quantify mediators and moderators of intervention treatment effects.

NCT ID: NCT03629678 Active, not recruiting - Sickle Cell Disease Clinical Trials

Using Patient-Centered Guidelines in a Technology Platform to Improve Health Care in Adults With Sickle Cell Disease

Start date: July 1, 2018
Phase: N/A
Study type: Interventional

SCD is an inherited disorder of hemoglobin that affects over 100,000 Americans, most of whom live in low-resourced neighborhoods. Acute SCD complications result in 230,000 emergency department visits and $1.5 billion annually in acute-care expenditures. Prior research indicates that increased disease-specific knowledge correlates with improved clinical outcomes in SCD. Thus, targeting strategies to improve disease-specific knowledge is a high priority in the care of individuals with SCD. Significant evidence describes how educational materials, including online educational programs, can be used to increase disease-specific knowledge. In this study, the investigators will evaluate a mobile phone technology intervention based on the prior evidence that technologies can improve SCD-specific knowledge.