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Purpose

To assess the pharmacokinetics, pharmacodynamics and safety of Epeleuton capsules in adult SCD patients who are aged ≥18 years.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Epeleuton 4g/day
  • Drug: Epeleuton
    Participants will receive 2000mg Epeleuton (DS102) capsules twice daily.
    Other names:
    • DS102 Capsules

Recruiting Locations

University of Alabama at Birmingham (UAB)
Birmingham, Alabama 35294
Contact:
Study Coordinator
205-975-6215
info@afimmune.com

More Details

Status
Recruiting
Sponsor
Afimmune

Study Contact

Detailed Description

The trial will consist of a 28-day screening period, 16 weeks of active treatment and a 30-day post-treatment follow-up period.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.