Senicapoc for Sickle Cell Disease
(RESCUE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
SIL-8301 (senicapoc) is being developed for the chronic treatment of patients with sickle cell disease in both adults and children. The purpose of this study is to compare the effects of senicapoc to placebo in patients with sickle cell disease that have had fewer than 2 acute sickle-related painful crises per year over the preceding 2 years, and have a predominantly hemolytic phenotype, defined as presence or history of at least one hemolytic complication and a baseline Hb of 9 g/dL or less, despite receiving hydroxyurea (an oral drug used for treatment of sickle cell disease) as standard of care. Participants will take senicapoc or matching placebo daily and continue on hydroxyurea as prescribed for up to 24 weeks.
Are You a Good Fit for This Trial?
This trial is for people aged 16-35 with sickle cell disease, low hemoglobin (9 g/dL or less), who have had no more than one painful crisis per year in the last two years, at least one past complication from red blood cell breakdown, and are currently taking hydroxyurea.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Senicapoc
Trial Overview
The study compares a new daily medication called senicapoc to a placebo. All participants will keep taking their usual hydroxyurea treatment. The goal is to see if senicapoc helps control red blood cell breakdown over about 24 weeks.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
20 mg twice daily for 4 days, followed by 10 mg once daily for up to 24 weeks
Matching placebo tablets twice daily for 4 days, followed by once daily for up to 24 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
Biossil Inc.
Lead Sponsor
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