Crizanlizumab for Sickle Cell Disease

Phase 4

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not have

SCD patients who do not meet parent study protocol criteria to continue with crizanlizumab

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day of first dose of study medication to 105 days after last dose of study medication

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will allow continued access to the drug crizanlizumab for patients with sickle cell disease who are benefiting from the treatment.

Who is the study for?

This trial is for patients with Sickle Cell Disease who are already participating in a Novartis-sponsored Crizanlizumab study and have seen benefits. They must have completed the previous study's treatment schedule, shown commitment to visit schedules, and be willing to continue visits. Pregnant or nursing women, those not using effective contraception, or anyone with unresolved severe side effects from prior treatments cannot join.

What is being tested?

The trial provides continued access to Crizanlizumab for individuals with Sickle Cell Disease who benefited from earlier trials. It's designed as a rollover study where participants receive ongoing Crizanlizumab therapy under the supervision of investigators at multiple centers internationally.

What are the potential side effects?

While specific side effects aren't listed here, participants will be monitored for any adverse events related to Crizanlizumab use. Those with Grade 3 (severe) or higher side effects from previous studies are excluded unless resolved.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have SCD and cannot continue with crizanlizumab as per the main study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ not applicable - study completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~not applicable - study completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and not applicable - study completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Not Applicable as this protocol is to provide an option for continued access to crizanlizumab for patients with Sickle Cell Disease who have completed a prior Novartis-sponsored Crizanlizumab study

Secondary study objectives

Number of participants with treatment emergent adverse events