Senicapoc for Sickle Cell Disease with Hemolytic Phenotype

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial evaluates senicapoc versus placebo added to standard hydroxyurea therapy in adults and adolescents with sickle cell disease and a predominantly hemolytic profile. Participants must have Hb ≤ 9.5 g/dL and few prior painful crises to participate. The study uses a randomized design with daily oral dosing for up to 24 weeks, followed by an optional open-label extension for up to 2 years. The goal is to see if senicapoc can reduce hemolysis and improve hemoglobin levels while maintaining safety. Lead sponsor is Biossil Inc., with sites in Toronto and Montreal.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Documented diagnosis of sickle cell disease (SCD)
* 16-50 years of age
* Hemoglobin (Hb) ≤ 9.5 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
* Steady-state hemolysis
* Current treatment with hydroxyurea

Exclusion Criteria:

* 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

Where it's running

• The Hospital for Sick Children
  Toronto, Ontario, Canada Recruiting
• University Health Network, Toronto General Hospital
  Toronto, Ontario, Canada Recruiting
• Centre Hospitalier de l'Université de Montréal (CHUM)
  Montreal, Quebec, Canada Recruiting
• McGill University Health Centre
  Montreal, Quebec, Canada Recruiting

Study contacts

• Study coordinator: Head of Clinical Operations
• Email: trials@biossil.ai
• Phone: (978) 245-7397

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.