BridgeMD
Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents with Sickle Cell Disease during Vaso-Occlusive Crisis
EU CTIS ID: 2024-513440-29-00
What this study is testing
The main objectives of this study are to evaluate the safety and tolerability of CSL889 administered by intravenous (IV) infusion in study subjects, and to evaluate the effect of CSL889 (human hemopexin) on time to resolution of vaso-occlusive crisis (VOC) in participants with sickle cell disease (SCD).
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 endorsement of the Independent Data Monitoring Committee [IDMC]). •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 or equal to (>=) 72 hours before administration of first parenteral opioid (Part A; may be adjusted for Part B based on prespecified analysis). • Must not have a history of greater than (>) 5 VOCs requiring hospital admission in the past 6 months; or signs and / or symptoms of ACS; or new neurological symptoms suggestive of acute stroke or transient ischemic attack; or any stage (acute kidney injury) AKI; or been discharged from inpatient hospital admission for VOC or other vaso-occlusive event within 14 days before the current presentation. •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 regimen, currently taking methadone or buprenorphine."
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- United States
- United Kingdom
- Canada
- Saudi Arabia
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 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, 65+ years, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; United States; United Kingdom; Canada; Saudi Arabia. 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 EU CTIS; the study team decides eligibility.