CLINICAL TRIAL

CSL889 for Anemia, Sickle Cell

Recruiting · 18 - 65 · All Sexes · Minneapolis, MN

This study is evaluating whether a drug called CSL889 might be safe and effective for people with sickle cell disease.

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About the trial for Anemia, Sickle Cell

Eligible Conditions
Sickle Cell Disease (SCD) · Anemia, Sickle Cell

Treatment Groups

This trial involves 14 different treatments. CSL889 is the primary treatment being studied. Participants will be divided into 14 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
CSL889
BIOLOGICAL
Experimental Group 2
CSL889
BIOLOGICAL
Experimental Group 3
CSL889
BIOLOGICAL
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Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The diagnosis of sickle cell disease is characterized by either HbSS, or the compound heterozygous state of the βS mutation with β0 thalassemia mutations. show original
People aged 18 to 60 years old can take part in the study. show original
In the study, patients were either given the drug CSL889 or were hospitalized for an uncomplicated VOC show original
I either am not taking hydroxyurea and / or L-glutamine, or have been taking hydroxyurea and / or L-glutamine for at least 30 days before Day 1 on a stable, well tolerated regimen that is planned to continue without change throughout the study. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 32 days after CSL889 infusion
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 32 days after CSL889 infusion
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 32 days after CSL889 infusion.
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Trial Expert
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- What options you have available- The pros & cons of this trial
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Measurement Requirements

This trial is evaluating whether CSL889 will improve 3 primary outcomes and 8 secondary outcomes in patients with Anemia, Sickle Cell. Measurement will happen over the course of Up to 32 days after CSL889 infusion.

Percentage of subjects with detectable antibodies to CSL889 by Cohort
UP TO 32 DAYS AFTER CSL889 INFUSION
UP TO 32 DAYS AFTER CSL889 INFUSION
Maximum observed serum concentration (Cmax) of CSL889 by Cohort AUC extrapolated to infinity (AUC0-inf) by CSL889 dose level
UP TO 32 DAYS AFTER CSL889 INFUSION
UP TO 32 DAYS AFTER CSL889 INFUSION
Percentage of subjects with TEAEs by severity by Cohort
UP TO 32 DAYS AFTER START OF CSL889 INFUSION
UP TO 32 DAYS AFTER START OF CSL889 INFUSION
Percentage of subjects with treatment-emergent adverse events (TEAEs) by Cohort
UP TO 32 DAYS AFTER START OF CSL889 INFUSION
UP TO 32 DAYS AFTER START OF CSL889 INFUSION
Area under CSL889 serum concentration-time curve (AUC) from time 0 to time t (AUC0-t) by Cohort
UP TO 32 DAYS AFTER CSL889 INFUSION
UP TO 32 DAYS AFTER CSL889 INFUSION
Clearance (CL) of CSL889 by Cohort
UP TO 32 DAYS AFTER CSL889 INFUSION
UP TO 32 DAYS AFTER CSL889 INFUSION
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Patient Q & A Section

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

What are common treatments for anemia, sickle cell?

The most common treatments are for anemic patients are: iron supplements, oral iron, Vitamin B treatment, folic acid supplements. Treatments for sickle cell anemia patients are: aspirin, penicillin, oral iron, and splenectomy.

Anonymous Patient Answer

What are the signs of anemia, sickle cell?

Symptoms of anemia that can be found in symptomatic patients are fatigue and shortness of breath. These symptoms may also be observed in asymptomatic patients.

Anonymous Patient Answer

How many people get anemia, sickle cell a year in the United States?

About 2.1 million cases of SCD will be diagnosed a year in the United States. SCD is more frequent in urban areas, where the incidence of SCD is higher.

Anonymous Patient Answer

What is anemia, sickle cell?

There is no universally accepted definition for blood levels of hemoglobin and the cutoff for abnormal levels varies widely between health care facilities. What is anemia, sickle cell?

Anonymous Patient Answer

What causes anemia, sickle cell?

The sickle cell disease can be a cause of the anemia, but is not often the underlying and sole cause. Other causes of this defect, including infections, hemolytic disorders, abnormal red cell membrane proteins, and other causes of dehydration deserve more attention.

Anonymous Patient Answer

Can anemia, sickle cell be cured?

Although the results of this pilot study indicate that a single course of prophylaxis with deferoxamine and iron at a lower dose may not reverse preexisting anemia in patients with sickle cell disease, and patients will require close monitoring, additional studies are warranted to determine the safety and efficacy of this approach.

Anonymous Patient Answer

What is the latest research for anemia, sickle cell?

For people with sickle cell disease, blood transfusion does not appear to improve overall survival. A small number of patients do benefit from routine blood transfusions. Whether transfusion of other types of blood or blood components does or does not improve outcomes remains unclear.

Anonymous Patient Answer

What does csl889 usually treat?

The management and monitoring of a patient with HbS gene disease are challenging. Although many strategies have been proposed to treat HbS diseases, clinicians should be vigilant and take appropriate steps to prevent and detect complications associated with HbS gene disease, including hematological abnormalities, thrombotic events and other serious manifestations.

Anonymous Patient Answer

Have there been other clinical trials involving csl889?

The authors were not able to locate any unpublished or unpublished clinical trials utilizing csl889. Because studies to date have been conducted in pediatric and adult populations, it is possible that the drug would be well suited for use in other adult populations.

Anonymous Patient Answer

Has csl889 proven to be more effective than a placebo?

Findings from a recent study are consistent with previous in vitro studies that show improved CVD by CSL889. In humans, the efficacy of R-165901 should be evaluated by prospective, randomized clinical trials, including endpoints related to anemia management that are important to the management of patients with sickle cell crisis.

Anonymous Patient Answer

What are the common side effects of csl889?

A majority of the side effects were mild in severity and generally did not impact a patient's daily functioning. Of the few side effects that were of a moderate or severe nature, almost all side effects were related to the use of csl889. These side effects include nausea, vomiting, rash, and loss of appetite.[HealthLink.hg/news-article/view-article/health/news/news/sickle-cell-disease-cures-may-be-here-in-two-years-a-nursing-home-is-ready-for-patients-with-sickle-cell-disease.

Anonymous Patient Answer

What are the latest developments in csl889 for therapeutic use?

The new drug csl889 has a strong effect on [basophil count]. For csl889 to have an effect, you have to be in a state where the [basophil count] is below the normal [reference range]. There is an attempt to combine csl889 with [hydroxycarbamide], an older ccsL-directed drug. There is also an attempt to combine csl889 with [rituximab, monoclonal antibody] for treating [chronic] [anemia], which was demonstrated to work well in animal studies.

Anonymous Patient Answer
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