105 Participants NeededMy employer runs this trial

Senicapoc for Sickle Cell Disease

(RESCUE Trial)

Recruiting at 3 trial locations
Ho
Ho
Overseen ByHead of Clinical Operations
Age: < 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Biossil Inc.
Prior Safety DataThis treatment has passed at least one previous human 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

I am between 16 and 35 years old.
I have had one or fewer sickle cell pain crises needing medical care each year in the last 2 years.
My hemoglobin level is 9.0 g/dL or lower.
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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

Group I: Senicapoc (SIL-8301)Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Biossil Inc.

Lead Sponsor

Trials
1
Recruited
350+