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DISC-3405-102 - Clinical Trial

¿Cuál es el Propósito de este estudio?

This study starts with a screening visit to see if a person can join. After that, there are thirteen study visits over about twenty weeks. During this time, participants will receive three shots of the study medicine called DISC 3045 given under the skin. All study visits include blood tests, and one visit will include two blood draws. People may also choose to stay in the study longer for another twelve weeks. If they continue, they will receive three more shots of the study medicine and have seven more study visits with blood tests.

¿Cuál es la Condición que se está estudiando?

Enfermedad de células falciformes

¿Quién puede participar en el Estudio?

People can join this study if they are 18 years old or older and have sickle cell disease. This includes two types called HbSS and HbSC. Their hemoglobin level must be at least 9. They must have had between one and ten sickle cell pain crises in the past year, or have had health problems linked to sickle cell disease such as eye damage, small strokes that do not cause symptoms, bone damage, or hearing loss. Their iron levels must also be within a certain range based on their type of sickle cell disease.

Grupo etario
Adultos

¿Qué Implica?

This study is testing a new medicine called DISC 3405 to see if it is safe. The medicine lowers iron levels in the body and is being studied for people with sickle cell disease. Lower iron levels may help reduce sickle hemoglobin in red blood cells. This can help keep the cells from becoming sickle shaped. It may also help stop red blood cells from breaking apart, which can lead to pain and trouble breathing.

Detalles del Estudio

Título Completo
A Phase 1b Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DISC-3405 in Participants with Sickle Cell Disease
Investigador Principal
John J. Strouse, MD, PhD
Especialista en hematología
Número de Protocolo
IRB: PRO00118958
NCT: NCT07187973
Fase
Fase I
ClinicalTrials.gov
Estado de inscripción
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Contribuya a Duke Health