Hibiscus Study: An oral investigational medication for SCD

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The Sickle Cell 101 research team in collaboration with study investigator have reviewed this information to ensure it is patient-friendly and accurate.

About the Study

The Hibiscus Study is enrolling adults and adolescents 12 to 65 years old with a clinical diagnosis of SCD. The primary purpose of the study is to evaluate the safety and effectiveness of an oral investigational medication for SCD.

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The investigational medication is being tested to see how well it works compared to placebo (inactive substance) to improve anemia and reduce the number of pain crises per year. The investigational medication or placebo are given as two tablets taken one time per day. The study length is 52 weeks, followed by an optional additional 52 week extension study, where all participants will receive investigational medication. A separate consent form will need to be signed to take part in the extension study. Study-specific investigational medication, medical exams and laboratory tests are available to you at no cost. Reimbursement for time and travel, as well as transportation to and from your study visits, may also be available to you.

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Participation information

Age

12

- 65

Gender

All

Genotypes

All types of SCD

Study Information

Study type

Clinical

Interventions

Oral FT-4202

Phase

2/3

Compensation

Reimbursement for time and travel may also be available

Am I Eligible?

Requirements

You may be eligible to participate in this study if you:
  • Patient has a confirmed diagnosis of sickle cell disease
  • Have experienced at least 2 pain episodes (vaso-occlusive crises) within the past 12 months, but not more than 10
  • Be willing and able to follow all study requirements and study visit schedules
  • Additional eligibility criteria will apply, and a study doctor will explain this information to you

Restrictions

You can't participate in this study if you:
  • More than 10 vaso-occlusive crises within the past 12 months
  • Female who is breastfeeding or pregnant
  • Known HIV positive
  • Active hepatitis B or hepatitis C infection
  • Severe kidney dysfunction or on chronic dialysis
  • Additional eligibility criteria will apply, and a study doctor will explain this information to you

Study point of contact

Forma Therapeutics
844-608-0808
Study Brochure Enroll in this Study
Last updated September 23, 2022
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