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Anemia, Sickle Cell clinical trials

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NCT ID: NCT04091737 Terminated - Anemia, Sickle Cell Clinical Trials

CSL200 Gene Therapy in Adults With Severe Sickle Cell Disease

Start date: October 2, 2019
Phase: Phase 1
Study type: Interventional

This is a phase 1 pilot study of CSL200 in adult subjects with severe sickle cell disease. The primary objectives of this study are to evaluate the safety of the following: collection of CD34+ hematopoietic stem / progenitor cells by apheresis after mobilization with plerixafor, reduced intensity conditioning with melphalan, and administration of CSL200.

NCT ID: NCT03978156 Terminated - Sickle Cell Disease Clinical Trials

Dronabinol for Pain and Inflammation in Adults Living With Sickle Cell Disease

Start date: July 26, 2019
Phase: Phase 1
Study type: Interventional

This study is designed to address the feasibility of a randomized, double masked, cross-over study of dronabinol as a palliative agent in the treatment of pain, inflammation, and other complications of sickle cell disease (SCD).

NCT ID: NCT03933397 Terminated - Sickle Cell Disease Clinical Trials

Comparing Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease

COMPARE-VOE
Start date: August 13, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to compare two different ways to give opioid pain medicine to treat sickle cell disease pain that is bad enough to go to the emergency department for treatment. One way uses your weight to decide how much pain medicine to give you while in the emergency department. This is called weight based treatment. The other way uses how much pain medicine you take at home and how much medicine you needed during past emergency department visits to decide how much medicine to give you. This is called patient specific treatment.

NCT ID: NCT03886753 Terminated - Cancer Clinical Trials

Pharmacokinetic (PK) and Pharmacodynamics (PD) Study of Ilera Specific Products

Ilera
Start date: May 15, 2019
Phase:
Study type: Observational

This is an observational study of medical marijuana manufactured and dispensed by Ilera and given as standard treatment for a variety of approved serious medical conditions as defined by individual state law. All patients who are receiving one of the four formulations (Dream, Soothe, Shine and Ease) of medical marijuana will be provided a study flyer and asked to contact the study team via phone or email. Once the study team confirms eligibility, the study team will meet the subject face-to-face most likely at their dispensary (or other mutually agreeable location) and obtain informed consent, and assent when appropriate. Initial baseline demographic information, medical history and medication inventory will be completed. Also, since it is possible that the Investigators will enroll subjects across the region, Investigators anticipate the need to seek consent over the phone for many patients. This will be done via Skype, Go to Meeting, Facetime or similar platforms so that the Investigators can have a face to face interaction with the potential subjects. Regardless of where this discussion takes place (i.e., in person or via the web), all reasonable safeguards to ensure patient privacy will be taken. Patients or their legally authorized representative (LAR) will be given sufficient (i.e., up to several hours/days) to make a decision to participate in this study. Study staff will fax or email the consent form for their signature and no study procedures will begin until the signed consent form is received by the study team. The subjects or their LARs will be instructed on obtaining the blood samples. Blood draws will be completed in the subjects' home after one of their standard doses is taken.

NCT ID: NCT03825341 Terminated - Sickle Cell Disease Clinical Trials

Hydroxyurea Therapy: Optimizing Access in Pediatric Populations Everywhere

Start date: June 10, 2019
Phase: Phase 2
Study type: Interventional

Primary Objective 1. Define the pharmacokinetics of liquid-formulated HU in infants (9 months to <2 years) 2. Assess the relative bioavailability of HU "sprinkles" compared to capsules in children and adolescents (≥2 to 18 years). Secondary Objective: Compare PK parameters in infants versus older children on this study and those from our previous "Pharmacokinetics and Bioavailability of a Liquid Formulation of Hydroxyurea in Pediatric Patients with Sickle Cell Anemia" (NCT01506544) trial. Exploratory Objectives: Capture information regarding the taste of HU sprinkles using palatability questionnaire. This trial is an open label, single center assessment of the pharmacokinetics of two formulations of hydroxyurea (HU) designed to (1) determine the pharmacokinetic profile of a liquid formulation in infants and to (2) determine the bioavailability of "sprinkles", a novel method of administration for older children. The study aims to generate data to facilitate FDA approval for HU in children and potentially validate a new mode of administration ("sprinkles") that will optimize access and adherence for children in the US and globally.

NCT ID: NCT03753854 Terminated - Sickle Cell Disease Clinical Trials

Sleep Apnea in Sickle Cell Disease

DREPAPNEE
Start date: May 28, 2018
Phase: N/A
Study type: Interventional

Despite the fact that obstructive sleep apnoea (OSA) is highly prevalent in the sickle cell population, studies focusing on the associations of the two diseases and their common pathophysiological mechanisms are scarce. OSA is one of the most common conditions responsible for hemoglobin desaturation. The nocturnal hemoglobin desaturation occurring in some sickle cell disease (SCD) patients with OSA could trigger hemoglobin S polymerization and red blood cell (RBC) sickling, leading to further blood rheological alterations, hence increasing the risks for VOC. Moreover, OSA has been demonstrated to increase oxidative stress and inflammation in non Sickle Cell Disease (SCD) patients, which, in SCD patients, could increase the risk for complications. Finally, OSA is accompanied by impaired vascular function and autonomic nervous system dysfunction in the general population. Indeed, the presence of OSA in SCD could increase the clinical severity of patients and the frequency of VOC.

NCT ID: NCT03733249 Terminated - Clinical trials for Myelodysplastic Syndromes

Long Term Follow-up Study for Patients Enrolled on the BP-004 Clinical Study

Start date: January 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a long-term follow up study evaluating the safety of BPX-501 T cells (rivogenlecleucel) and infused in pediatric patients previously enrolled on the BP-004 study.

NCT ID: NCT03694548 Terminated - Sickle Cell Disease Clinical Trials

Acceptability, Feasibility and Safety of a Yoga Program for Chronic Pain in Sickle Cell Disease

Start date: November 8, 2018
Phase: N/A
Study type: Interventional

Chronic Pain is associated with morbidity and poor quality of life in patients with Sickle Cell Disease (SCD). Complementary therapies, such as yoga are beneficial in patients with non-SCD chronic pain conditions. Yoga was shown to be acceptable, feasible and helpful in one study in acute SCD pain. The purpose of the study is to assess the acceptability, feasibility, and safety of yoga for chronic pain in SCD.

NCT ID: NCT03615924 Terminated - Sickle Cell Disease Clinical Trials

Effect of Ticagrelor vs. Placebo in the Reduction of Vaso-occlusive Crises in Pediatric Patients With Sickle Cell Disease

HESTIA3
Start date: September 26, 2018
Phase: Phase 3
Study type: Interventional

The purpose of the study is to Evaluate the Effect of Ticagrelor versus Placebo in Reducing the Rate of Vaso-Occlusive Crises in Paediatric Patients with Sickle Cell Disease

NCT ID: NCT03577691 Terminated - Sickle Cell Disease Clinical Trials

Efficacy of a Decision Aid for Hydroxyurea in Sickle Cell Disease

Start date: August 3, 2018
Phase: N/A
Study type: Interventional

The trial is a prospective, randomized study to determine the efficacy of training for use of a web based Decision Aid for Hydroxyurea(HU) usage among subjects with Sickle Cell Disease(SCD). Subjects are randomized primarily either to using a web based decision aid with training versus without training. Subjects in each group will be further randomized to 1) subjects receiving pretest surveys; and 2) subjects that do not receive pretest surveys.