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Tests treatment safety and results for Sickle Cell Disease Vaso-occlusive Crisis
Official title Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis
ClinicalTrials.gov ID: NCT06699849
What this study is testing
What is CSL889?
CSL889 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sickle cell disease vaso-occlusive crisis.
Also referred to as Hemopexin, human.
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
- This is a phase 2, randomized, multiple-dose, placebo-controlled study designed to evaluate the safety, efficacy, and pharmacokinetics (PK) of CSL889 (human hemopexin) when given intravenously (IV) to adults and adolescents with sickle cell disease (SCD) experiencing vaso-occlusive crises (VOC). The main objectives of the study are to evaluate the safety and tolerability of CSL889 in study participants, and to assess how CSL889 affects the time it takes for VOC to resolve in participants with SCD.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- At the time of informed consent:
- 18 years of age (adults); or
- 12 to less than (\<) 18 years of age (adolescents, where approved and when enrollment for adolescents has been opened by the sponsor, with the...
- Diagnosed with SCD (any genotype).
- Presented at the study site with a new acute VOC necessitating treatment with parenteral opioids.
You likely can't join if
- VOC pain onset greater than (\>) 72 hours before administration of first parenteral opioid.
- Must not have a history of \> 5 VOCs requiring hospital admission in the past 6 months; or signs and / or symptoms of ACS; or new neurological...
- Serum hemoglobin \< 6 g/dL, serum ferritin ≥ 2000 ng/mL, receiving an approved medication for SCD that has not been on a stable, well-tolerated...
The study team makes the final eligibility decision.
Where it's taking place
- Oakland, California, United States
- Orange, California, United States
- Fort Myers, Florida, United States
- Hollywood, Florida, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Detroit, Michigan, United States
- New York, New York, United States
- The Bronx, New York, United States
- Greenville, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Richmond, Virginia, United States
- Ankara, Turkey (Türkiye)
- Istanbul, Turkey (Türkiye)
- Seyhan, Turkey (Türkiye)
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oakland, California, United States; Orange, California, United States; Fort Myers, Florida, United States; Hollywood, Florida, United States; Louisville, Kentucky, United States; Baltimore, Maryland, United States and 11 more location(s). 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.