A Study of Nicotinamide With Oral Tetrahydrouridine and Decitabine to Treat High Risk Sickle Cell Disease

ConditionSickle Cell Disease

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorEpiDestiny, Inc.

About this trial

A randomized control trial in 20 subjects with sickle cell disease comparing oral THU-decitabine to nicotinamide and in combination (THU, decitabine and nicotinamide).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Inability to give informed consent.

Experienced severe sepsis or septic shock within the previous 12 weeks.

Last HU dose was ingested within the previous 4 weeks.

Currently pregnant or breast-feeding.

Trial design

Design model

Parallel

Treatments tested in this trial

Nicotinamide
Drug
Oral nicotinamide (Vitamin B3) alone compared to THU Decitabine combination

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: NicotinamideExperimental treatment 1 intervention

Group B: THU DecitabineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Blood Hemoglobin

Measure hemoglobin function

Time frame

12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EpiDestiny, Inc.

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

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