Sickle Cell Disease Vaso-occlusive Crisis study: CSL889
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 IV infusion (through 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
- The study aims to find out whether CSL889 is safe and well‑tolerated, and whether it shortens the time it takes for a sickle cell pain crisis to resolve.
- Who it's for
- Adults and adolescents who have sickle cell disease and are currently experiencing a vaso‑occlusive (pain) crisis.
- What's involved
- Participants are randomly assigned to receive either CSL889 or a placebo through an IV, given in several doses, with regular safety checks and blood tests to measure the drug’s behavior in the body.
- Time commitment
- The trial runs for the duration of the crisis with multiple dosing visits and follow‑up appointments over a few weeks.
- 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
- 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
- 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 is enrolling
- Oakland, California, United States
- Orange, California, United States
- Washington D.C., District of Columbia, United States
- Fort Myers, Florida, United States
- Hollywood, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Detroit, Michigan, United States
- St Louis, Missouri, 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
- Adana, Turkey (Türkiye)
- Ankara, Turkey (Türkiye)
- Mezitli-Mersin, Turkey (Türkiye)
+ 5 more site(s).
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, but 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?
This study is enrolling now at Oakland, California, United States; Orange, California, United States; Washington D.C., District of Columbia, United States; Fort Myers, Florida, United States; Hollywood, Florida, United States; Atlanta, Georgia, United States and 19 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.