Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Afimmune
The trial will consist of a 28-day screening period, 16 weeks of active treatment and a 30-day post-treatment follow-up period.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients with sickle cell disease (SCD) including:
* 2 sickle hemoglobin genes \[HbSS\]
* HbSβ0 thalassemia
* HbSβ+ thalassemia
* Heterozygous for hemoglobin S and hemoglobin C \[HbSC\]
Male or female patients aged 18 years and older on the day of signing the informed consent form (ICF)
Patients who have had between 2 and 15 episodes of vaso-occlusive crisis (VOC) in the past year (12 months)
For patients taking hydroxyurea (HU), the dose of HU must be stable for at least 3 months prior to signing the ICD and with no anticipated need for dose adjustment during the study.
Female patients and male patients with female partners of childbearing potential must use highly effective contraceptive methods for the duration of the study.
You may not be if
Patients who are receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion), have received an RBC transfusion for any reason within three months of the baseline visit
Patients who have received a hematopoietic stem cell transplant.
Patients with inadequate venous access as determined by the Investigator
Patients who are pregnant, planning pregnancy, breastfeeding and/or are unwilling to use adequate contraception during the trial.
Clareo Health | Pharmacokinetics, Pharmacodynamics and Safety of Epeleuton in Patients With Sickle Cell Disease
