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CSL889 for Sickle Cell Disease

Phase 1
Waitlist Available
Research Sponsored by CSL Behring
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 32 days after csl889 infusion
Awards & highlights

Study Summary

This trial is testing a new drug for sickle cell disease. The drug will be given to people in increasing doses to see if it is safe and effective.

Eligible Conditions
  • Sickle Cell Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 32 days after csl889 infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 32 days after csl889 infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of subjects with TEAEs by causality by Cohort
Percentage of subjects with TEAEs by severity by Cohort
Percentage of subjects with treatment-emergent adverse events (TEAEs) by Cohort
Secondary outcome measures
Area under CSL889 serum concentration-time curve (AUC) from time 0 to time t (AUC0-t) by Cohort
Clearance (CL) of CSL889 by Cohort
Maximum observed serum concentration (Cmax) of CSL889 by Cohort
+5 more

Trial Design

8Treatment groups
Experimental Treatment
Group I: CSL889 Cohort B2 (high dose)Experimental Treatment1 Intervention
CSL889 administered as a single IV infusion
Group II: CSL889 Cohort B1 (low dose)Experimental Treatment1 Intervention
CSL889 administered as a single IV infusion
Group III: CSL889 Cohort A6 (Dose 6)Experimental Treatment1 Intervention
CSL889 administered as a single IV infusion
Group IV: CSL889 Cohort A5 (Dose 5)Experimental Treatment1 Intervention
CSL889 administered as a single IV infusion
Group V: CSL889 Cohort A4 (Dose 4)Experimental Treatment1 Intervention
CSL889 administered as a single IV infusion
Group VI: CSL889 Cohort A3 (Dose 3)Experimental Treatment1 Intervention
CSL889 administered as a single IV infusion
Group VII: CSL889 Cohort A2 (Dose 2)Experimental Treatment1 Intervention
CSL889 administered as a single IV infusion
Group VIII: CSL889 Cohort A1 (Dose 1)Experimental Treatment1 Intervention
CSL889 administered as a single IV infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CSL889
2021
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

CSL BehringLead Sponsor
194 Previous Clinical Trials
1,211,194 Total Patients Enrolled
Study DirectorStudy DirectorCSL Behring
1,206 Previous Clinical Trials
489,626 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the qualifications for this trial compatible with my profile?

"Qualified applicants for this medical study should have anemia, suffer from sickle cell disease, and be between 18 to 60 years old. Currently, there are 32 openings available."

Answered by AI

Does the age bracket for this clinical experiment extend beyond 20 years of age?

"This clinical trial is available to those aged 18 and over, but not exceeding 60 years old."

Answered by AI

How many participants are currently receiving treatment through this research?

"For successful completion of this research, 32 compliant participants must be recruited from two specified sites: University Of Illinois Hospital and Health Science Systems in Chicago, Illinois and Medical University of South carolina in Charleston, South Carolina."

Answered by AI

Are there multiple sites in the US conducting this research trial?

"Six medical sites are currently engaging in this clinical trial, such as the University of Illinois Hospital and Health Science Systems in Chicago, Medical University of South carolina at Charleston, and Ohio State University situated in Columbus. Additionally, there are 3 other places participating."

Answered by AI

Has CSL889 obtained regulatory confirmation from the Food and Drug Administration?

"The safety of CSL889 is tentatively rated at 1, considering that this trial is in its initial phase and there exists a limited amount of evidence confirming efficacy and security."

Answered by AI

Is there still capacity for participants in this trial?

"This investigation, which was registered on the 20th of May 2021 and updated last month, is presently looking for participants. According to clinicaltrials.gov, recruitment is underway."

Answered by AI
~7 spots leftby Apr 2025