Evaluating CSL889 for treating vaso-occlusive crises in sickle cell disease

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 clinical trial is designed to assess the safety, efficacy, and pharmacokinetics of CSL889, a human hemopexin, administered intravenously to adults and adolescents with sickle cell disease experiencing vaso-occlusive crises. The study consists of two parts: a phase 2 component focusing on initial safety and efficacy, followed by a phase 3 component to further evaluate these aspects in a larger population. Participants will be monitored for the resolution time of vaso-occlusive crises and the overall tolerability of the treatment. The trial aims to provide valuable insights into a potential new therapeutic option for managing this painful condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 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.

Where it's running

• Univ. of California, San Francisco Health Care
  Oakland, California, United States Recruiting
• University of California Irvine
  Orange, California, United States Recruiting
• Medstar Washington Hospital Center
  Washington D.C., District of Columbia, United States Recruiting
• Golisano Children's Hospital
  Fort Myers, Florida, United States Recruiting
• The Foundation for Sickle Cell Disease
  Hollywood, Florida, United States Recruiting
• Arthur M. Blank Hospital-Children's Healthcare of Atlanta
  Atlanta, Georgia, United States Recruiting

Study contacts

• Study coordinator: Trial Registration Coordinator
• Email: clinicaltrials@cslbehring.com
• Phone: +1 610-878-4697

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• IgPro20 in adults with immune deficiencies after CAR T-cell or T-cell redirecting therapies

  This study tests IgPro20 in adults with secondary immune deficiency after CAR T-cell or T-cell redirecting therapies to see if it lowers serious bacterial infections.

  Recruiting at 2 sites Phase 3 CSL Behring · Orange, California and 59 other locations · NCT07648264

• CSL300 in Chinese adults with End Stage Kidney Disease on dialysis

  This study tests how CSL300 behaves in the body after single and multiple doses in Chinese adults with end stage kidney disease on dialysis, compared with placebo.

  Recruiting Phase 1 CSL Behring · Beijing · NCT07619820

• Testing CE1226 doses to slow lung disease in adults with alpha-1 antitrypsin deficiency

  This trial tests two active doses of CE1226 to see if they slow lung density decline in adults with AAT deficiency and emphysema over 3 years compared with the standard 60 mg/kg dose.

  Recruiting at 2 sites Phase 4 CSL Behring · Aalborg and 1 other locations · NCT07326592

• Testing Anumigilimab (CSL324) safety in adults with sickle cell disease

  This study will test whether subcutaneous Anumigilimab is safe for adults with sickle cell disease who had 1–12 painful vaso-occlusive crises in the past year.

  Recruiting at 38 sites Phase 2 CSL Behring · Little Rock, Arkansas and 37 other locations · NCT07224360

• Comparing 4F‑PCC (BE1116) and fresh frozen plasma to treat bleeding during complex heart surgery with cardiopulmonary bypass

  This trial tests whether BE1116 (a 4‑factor prothrombin complex concentrate) works better than fresh frozen plasma to correct clotting problems in adults who bleed during complex heart surgery with cardiopulmonary bypass.

  Recruiting at 15 sites Phase 3 CSL Behring · Los Angeles, California and 23 other locations · NCT07094087

• Single-dose CSL222 gene therapy for adolescent males (12–17) with severe or moderately severe hemophilia B.

  This will give a single dose of CSL222 gene therapy to adolescent males with severe or moderately severe hemophilia B to see if it raises factor IX activity and reduces bleeding.

  Recruiting at 17 sites Phase 3 CSL Behring · Orange, California and 16 other locations · NCT07080905

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.