Pharmacokinetics, Pharmacodynamics and Safety of Epeleuton in Patients With Sickle Cell Disease
NCT ID: NCT05861453
Last Updated: 2025-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2024-01-10
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Dose-Finding Study of AG-348 in Sickle Cell Disease
NCT04000165
A Study of the Effect of IW-1701 (Olinciguat), a Stimulator of Soluble Guanylate Cyclase (sGC), on Patients With Sickle Cell Disease (SCD)
NCT03285178
A Phase 2/3 Study in Adult and Pediatric Participants With SCD
NCT05431088
A Study to Evaluate GBT021601-012 Single Dose and Multiple Dose in Participants With Sickle Cell Disease (SCD)
NCT04983264
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
NCT04610866
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Epeleuton 4g/day
Epeleuton
Participants will receive 2000mg Epeleuton (DS102) capsules twice daily.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Epeleuton
Participants will receive 2000mg Epeleuton (DS102) capsules twice daily.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Afimmune
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
New England Sickle Cell Institute, UConn Health
Farmington, Connecticut, United States
Medstar Health
Washington D.C., District of Columbia, United States
Aflac Cancer and Blood Disorders Center, Children's Healthcare of Atlanta at Hughes Spalding
Atlanta, Georgia, United States
Emory University - Georgia Comprehensive Sickle Cell Center
Atlanta, Georgia, United States
Aflac Cancer and Blood Disorders Center, Children's Healthcare of Atlanta at Arthur M. Blank Hospital
Atlanta, Georgia, United States
UI Health Sickle Cell Center
Chicago, Illinois, United States
The Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
The Center for Cancer and Blood Disorders, A Division of American Oncology Partners, PA
Bethesda, Maryland, United States
Kaiser Permanente Mid-Atlantic States
Largo, Maryland, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Robert Wood Johnson Medical School Rutgers
New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Jacobi Medical Center
The Bronx, New York, United States
UNC Health
Chapel Hill, North Carolina, United States
Science 37
Morrisville, North Carolina, United States
St Paul's Hospital Hematology/Oncology Research
Vancouver, British Columbia, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DS102A-10-RD2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.