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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
EpiDestiny, Inc.
Study ID
NCT04055818
Phase
PHASE1
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nicotinamide — DRUG
    Oral nicotinamide (Vitamin B3) alone compared to THU Decitabine combination

Study Details

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

Key Dates

Start date
Jan 24, 2020
Status verified
May 2025
Primary completion
Oct 30, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nicotinamide
    Oral Nicotinamide 1000 mg twice daily
  • Experimental: THU Decitabine
    Oral 250 mg THU and 5 mg decitabine Once per week

Primary Outcome Measure

Blood Hemoglobin [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois at Chicago College of MedicineChicagoIllinois60612
Lani Krauz
312-413-0242

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