Trial studying safety and effects for Sickle Cell Disease
Official title Efficacy and Safety of SIL-8301 for Control of Hemolysis in a Uniform Sickle Cell Disease Endotype
ClinicalTrials.gov ID: NCT07282210
What this study is testing
What is Senicapoc?
Senicapoc is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for sickle cell disease.
Also referred to as SIL-8301.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 35
You may be able to join if
- Documented diagnosis of sickle cell disease
- 16-35 years of age
- Hb ≤ 9.0 g/dL
- History of no more than 1 acute SCD-related painful crises requiring a visit to a medical facility per year within the preceding 2 years
- History of at least one hemolytic complication
You likely can't join if
- Receipt of senicapoc in a previous investigational study
- Current Red Blood Cell (RBC) transfusion or exchange transfusion program
- History of pulmonary hypertension
- Active cardiovascular, neurologic, endocrine, hepatic, or renal disorders
- Diagnosis of cancer (except non-melanoma skin cancer in situ, cervical cancer in situ, or breast cancer in situ) within the last 5 years
- History of liver disease
See the full eligibility criteria
- Documented diagnosis of sickle cell disease
- 16-35 years of age
- Hb ≤ 9.0 g/dL
- History of no more than 1 acute SCD-related painful crises requiring a visit to a medical facility per year within the preceding 2 years
- History of at least one hemolytic complication
- Current treatment with hydroxyurea
- Receipt of senicapoc in a previous investigational study
- Current Red Blood Cell (RBC) transfusion or exchange transfusion program
- History of pulmonary hypertension
- Active cardiovascular, neurologic, endocrine, hepatic, or renal disorders
- Diagnosis of cancer (except non-melanoma skin cancer in situ, cervical cancer in situ, or breast cancer in situ) within the last 5 years
- History of liver disease
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 35 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.