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Anemia, Sickle Cell clinical trials

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NCT ID: NCT02516579 Completed - Sickle Cell Disease Clinical Trials

European Sickle Cell Disease Cohort - Hydroxyurea

ESCORT-HU
Start date: January 2009
Phase:
Study type: Observational

In the context of the Risk Management Plan (RMP), as requested from Addmedica by the EMEA, to collect information about long-term safety of Siklos® (hydroxycarbamide) when used in patients with Sickle Cell Disease.

NCT ID: NCT02515838 Completed - Sickle-Cell Disease Clinical Trials

Sevuparin Infusion for the Management of Acute VOC in Subjects With SCD

Start date: July 2015
Phase: Phase 2
Study type: Interventional

A Multi-Centre, Phase II, Randomized, Double-Blind, Placebo-Controlled Study to investigate Efficacy and Safety of Sevuparin Infusion for the Management of Acute Vaso-Occlusive Crisis (VOC) in Subjects with Sickle-Cell Disease (SCD).

NCT ID: NCT02511769 Completed - Sickle Cell Disease Clinical Trials

Web-MAP Intervention for Youth With Sickle Cell Disease

Web-MAP
Start date: September 2013
Phase: N/A
Study type: Interventional

The proposed study will determine whether the efficacy of WebMAP cognitive behavioral therapy (CBT) treatment study generalizes to pediatric sickle cell disease (SCD), and explore whether the intervention is feasible and acceptable to this population. Feasibility of multi-institutional recruitment from sickle cell centers will also be determined. The short-term goal is to produce preliminary data to apply for an R01 proposal to carry out a multi-institutional randomized controlled trial (RCT) of internet-delivered behavioral intervention in a large population of youth with SCD. The long-term goal of this research is to develop effective, easily accessible, behavioral pain interventions for youth with SCD to reduce the long-term impact of pain on function, quality of life, and health service use in this population. The design of this study is an experimental 2 (group) x 3 (time of measurement) randomized controlled trial design to test the acceptability and efficacy of the Web-MAP intervention in reducing pain and functional impairment in youth with sickle cell disease. (Figure 1) Subjects will be randomized to either the behavioral intervention or the online patient education control group. The treatment protocol will be implemented over 8 weeks in Internet-based treatment modules. The primary study outcome is pain and functional impairment measured at baseline, immediately post-treatment, and at 3-month follow-up.

NCT ID: NCT02501447 Completed - Stress Clinical Trials

Feasibility of a Stress Reduction Intervention Study in Sickle Cell Disease

Start date: November 2013
Phase: N/A
Study type: Interventional

Stress is known to trigger acute pain crisis of sickle cell disease (SCD). SCD is an inherited blood disorder that afflicts about 100,000 people in the United States, and is among the most common lethal genetic diseases in the United States. Though worldwide in distribution, in the US it is most commonly found in African Americans. Its best known complication is severe, recurrent relentless pain, often known as pain crisis. Non-drug treatment for SCD pain such as cognitive coping interventions have been shown to be effective for reducing SCD pain intensity, but they are complicated, multifaceted, and time-consuming. A simple and cost-effective alternative such as guided imagery (GI) could reduce the effect of stress on SCD pain. GI is an intervention where patients listen to and view audio-visual recordings while being directed to visualize themselves being immersed in that scene or scenario. There are no published studies on the use of GI as a simple stress coping intervention or tracking stress in a systematic manner as a trigger for SCD pain.

NCT ID: NCT02497924 Completed - Anemia, Sickle Cell Clinical Trials

A Study of the Absorption, Metabolism, and Excretion of GBT440 in Healthy Male Subjects

Start date: June 2015
Phase: Phase 1
Study type: Interventional

This study will provide information regarding the metabolic pathway of GBT440, the need for evaluation of potential drug-drug interactions, and the need for studies in special populations. The administration of radiolabeled drug is necessary to fully characterize the rates and routes of elimination of GBT440, providing further quantitative information on the disposition of GBT440. The results from this study will permit a comprehensive comparison between animal and human routes of elimination and metabolic profiles of GBT440.

NCT ID: NCT02482298 Completed - Sickle Cell Disease Clinical Trials

A Study to Assess the Effect of Ticagrelor in Reducing the Number of Days With Pain in Patients With Sickle Cell Disease

Hestia2
Start date: July 9, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether ticagrelor is effective in reducing the number of days of pain, intensity of pain, and reducing the use of analgesics due to sickle cell disease

NCT ID: NCT02475993 Completed - Sickle Cell Disease Clinical Trials

SMART Mobile Application Technology Utilization in the Treatment of Sickle Cell Disease Post Day Hospital Discharge

Start date: July 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to test a web-aided, mobile-based PHR (Personal Health Reporting) service to enhance SCD outpatient treatment after discharge from an acute care setting, such as Duke University Medical Center's Day Hospital. SMART is a new mobile application created by SickleSoft to increase patient involvement in their treatment and improve patient to doctor communication. SMART is a self-monitoring and management service for SCD patients and their treatment doctors. This study will test whether or not use of the SMART mobile application will help develop the type of patient-doctor relationships that lead to better health outcomes and a decrease in readmission to an acute care facility.

NCT ID: NCT02467257 Completed - Sickle Cell Anemia Clinical Trials

Gum Arabic as Fetal Hemoglobin Agent in Sickle Cell Anemia

Start date: April 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether Gum Arabic is effective as fetal hemoglobin inducing agent for sickle cell anemia patients.

NCT ID: NCT02466555 Completed - Sickle Cell Disease Clinical Trials

Music Therapy in Sickle Cell Transition Study

Start date: June 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effects of the BEATS Music Therapy Program on the self-efficacy, trust, knowledge, and adherence of young adult patients with sickle cell disease during transition. Primary Hypotheses: Compared to baseline, young adult patients with sickle cell disease who receive the music therapy interventions will report: 1. Higher sickle cell self-efficacy as measured by the Sickle Cell Self Efficacy Scale (SCSES), 2. Higher trust in health care providers as measured by the Wake Forest Trust in the Medical Profession Scale, and 3. Higher sickle cell disease knowledge as measured by the Seidman Sickle Cell Knowledge Quiz. Secondary Hypotheses 1. Compared to the one year prior to the study period, young adults with sickle cell disease who receive the music therapy interventions will have a higher rate of adherence to clinic appointments during the one-year study period. Additional Questions 1. Do music therapy interventions influence attendance to scheduled blood transfusions? 2. Do music therapy interventions influence the rate of hospital utilization as measured by Emergency Department visits, Acute Care Clinic visits, and admissions during the study period compared to the previous year? 3. Do music therapy interventions influence adherence to hydroxyurea therapy for patients receiving hydroxyurea as measured by change in mean corpuscular volume (MCV) during the study period? 4. Do music therapy interventions influence adherence to iron chelation therapy for patients receiving iron chelation therapy as measured by ferritin count during the study period?

NCT ID: NCT02449616 Completed - Sickle Cell Disease Clinical Trials

Evaluation of Repeat Administration of Purified Poloxamer 188

EPIC-E
Start date: June 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety of repeat administration of MST-188 during vaso-occlusive crisis of sickle cell disease. Additionally, this study will evaluate the development of acute chest syndrome during VOC and re-hospitalization for recurrence of VOC.