A Study of Nicotinamide With Oral Tetrahydrouridine and Decitabine to Treat High Risk Sick
A randomized control trial in 20 subjects with sickle cell disease comparing oral THU-decitabine to nicotinamide and in combination (THU, decitabine and nicotinamide).
| Condition(s) | Sickle Cell Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | A randomized control trial in 20 subjects with sickle cell disease comparing oral THU-decitabine to nicotinamide and in combination (THU, decitabine and nicotinamide). |
| Who can participate | Inclusion Criteria: * Age 18 years or older. * Written informed consent provided by the subject before study entry. * Confirmed sickle cell disease (SCD) as determined by hemoglobin electrophoresis or liquid chromatography. * Subject is in his/her steady state and not having any acute complication due to SCD (i.e., hospitalization, acute pain, or acute chest syndrome in the past 14 days). * Weight at least 40kg * Regular compliance with comprehensive care and previous therapy. * Symptomatic SCD is defined as having one of following, despite at least 6 months of hydroxyurea therapy, or refuse to take hydroxyurea for personal reasons: fetal hemoglobin \<0.5 g/dL, or 3 or more pain episodes per year requiring parenteral narcotics, or 1 or more acute chest syndrome episodes, or Hemoglobin \<9 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | EpiDestiny, Inc. |
| Locations | Chicago, Illinois, United States |
| Start date | 2020-01-24 |
| NCT ID | NCT04055818 |
| Official listing | https://clinicaltrials.gov/study/NCT04055818 |