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Anemia, Sickle Cell clinical trials

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NCT ID: NCT05139992 Completed - COVID-19 Clinical Trials

COVID-19 Vaccine Response in Sickle Cell Disease

Start date: December 1, 2021
Phase:
Study type: Observational

The purpose of this study is to assess the antibody response to COVID-19 vaccination in a cohort of patients with sickle cell disease (SCD) and to assess vaccine and SCD related complications around the time of vaccination.

NCT ID: NCT05098028 Completed - Sickle Cell Disease Clinical Trials

Pharmacokinetics and Pharmacodynamics of Rifaximin Novel Formulations in Patients With Sickle Cell Disease

Start date: March 22, 2022
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled study in sickle cell disease participants with a history of Vaso-occlusive Crises (VOCs). Approximately 60 participants with sickle cell disease will be enrolled and randomized: 12 participants in each of four active novel formulation rifaximin groups and 6 participants in each of 2 placebo groups.

NCT ID: NCT05081349 Completed - Sickle Cell Disease Clinical Trials

Hydoxycarbamide and L-Carnitine Therapy in Sickle Cell Anemia

Start date: January 10, 2017
Phase: Phase 4
Study type: Interventional

The role of the combination therapy of hydroxyurea and L-Carnitine was studied in thalassemic patients. nevertheless its role in sickle cell anemia patients was not investigated

NCT ID: NCT05036512 Completed - Sickle Cell Disease Clinical Trials

A Study to Evaluate GBT021601 in Single and Multiple Doses in Healthy Participants

Start date: December 9, 2020
Phase: Phase 1
Study type: Interventional

This first in human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and food effect of GBT021601, a hemoglobin S (HbS) polymerization inhibitor, in healthy participants.

NCT ID: NCT04983654 Completed - Anemia Clinical Trials

Functional and Mechanistic Characterization of Limb Ulcers in Patients With Sickle Cell Disease

DrepanO2
Start date: February 9, 2022
Phase: N/A
Study type: Interventional

Sickle Cell Disease is the most frequent genetic disease in the world (representing one birth over 1900, in France). The polymerization of the abnormal hemoglobin (i.e., HbS) when deoxygenated is at the origin of a mechanical distortion of red blood cells (RBC) into a crescent-like shape. Sickled RBCs are very fragile and rigid, which lead patients to have severe anemia and to develop frequent and repeated painful vaso-occlusive crises. Furthermore, the repetition of sickling-unsickling cycles causes irreversible damages to the RBCs, which shorten their half-life. Accumulation of free hemoglobin and heme in the plasma is involved in blood vessels lesions in both the macro- and micro- circulation. The resulting vascular dysfunction could explain why limb ulcers are 10 fold more frequent in patients with sickle cell disease compared to the general population and may happen at a younger age. Limb ulcers induce significant morbidity (delay of healing between 9 and 26 weeks in the french cohort), and are associated to significant pain (needing opioid pain-killer) and increase the risk of infection. Cost of care is also increased. Moreover, ulcers induce missed school and work days. Data on cutaneous microcirculation and ulcers physiopathology in patients with sickle cell disease are scarce. We want to realise a microcirculatory and neurological functional study of patients with with and without ulcers and a characterization of biomarkers present in the blood or in the wound fluid which can participate to ulcers physiopathology. To ensure healing, adapted therapeutics are essential. Several strategies are proposed such as: lifestyle measures (venous compression, lower limb elevation, rest), dressings, hyperbaric oxygenotherapy (also used in diabetic ulcers). The project is devoted to study the mechanisms involved in leg ulcers and the effects of therapeutical/behavioral strategies.

NCT ID: NCT04983264 Completed - Sickle Cell Disease Clinical Trials

A Study to Evaluate GBT021601-012 Single Dose and Multiple Dose in Participants With Sickle Cell Disease (SCD)

Start date: May 21, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK), and pharmacodynamics (i.e., how the body absorbs, distributes, breaks down, and excretes) of GBT021601, a hemoglobin S (HbS) polymerization inhibitor, in participants with SCD, following single and multiple ascending doses.

NCT ID: NCT04930328 Completed - Sickle Cell Disease Clinical Trials

Retrospective Real World Oxbryta® Data Collection and Analysis Study

RETRO
Start date: March 20, 2021
Phase:
Study type: Observational

The aim of this study is to collect and analyze retrospective data on Oxbryta in a real-world setting. This is a multicenter, retrospective data collection and analysis study to characterize health outcomes in approximately 300 patients with SCD who have been treated with Oxbryta as part of their usual care. Any patient with SCD who received Oxbryta treatment for at least 2 weeks as part of their usual care according to the Oxbryta US Prescribing Information (USPI) is eligible to participate. Study data from 1 year before and up to 1 year after the first dose of Oxbryta will be entered in case report forms (CRFs) via an electronic data capture (EDC) system by the study staff.

NCT ID: NCT04917783 Completed - Sickle Cell Disease Clinical Trials

Health Literacy - Neurocognitive Screening in Pediatric SCD

Start date: September 25, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to determine feasibility and potential benefits of providing a passport card with a summary of neurocognitive feedback results to families of patients with sickle cell disease. Given recent literature suggesting the need to be conscious of health literacy in populations with low socioeconomic status, this project is intended to provide a more health-literate appropriate format of neurocognitive evaluation feedback in the context of a routine screening program offered as a standard of care in the CHW pediatric sickle cell disease clinic. The specific aims is (1) to evaluate differences in caregiver understanding of neurocognitive report findings when provided with a health-literate passport card compared to control group and (2) to evaluate differences in follow-through on neurocognitive report recommendations when provided with a health-literate passport card compared to control group.

NCT ID: NCT04906707 Completed - Sickle Cell Disease Clinical Trials

Home-Based Intervention for Chronic Pain in Adults With Sickle Cell Disease

Start date: October 27, 2021
Phase: N/A
Study type: Interventional

This project will evaluate AppliedVR's EaseVRx - a multi-modal, skills-based, 8-week, virtual reality, home intervention - in an exploratory randomized controlled trial for self-management of chronic pain among Black, young adults (ages 18-50) with sickle cell disease.

NCT ID: NCT04892160 Completed - Sickle Cell Disease Clinical Trials

Distracting Through Procedural Pain and Distress

Start date: February 15, 2018
Phase: N/A
Study type: Interventional

Children with acute and chronic illness undergo frequent, painful, and distressing procedures. This randomized control trial was used to evaluate the effectiveness of guided imagery (GI) vs virtual reality (VR) on the procedural pain and state anxiety of children and young adults undergoing un-sedated procedures. We explored the role of trait anxiety and pain catastrophizing in intervention response.