A Study to Evaluate the Safety and Efficacy of Crizanlizumab in Sickle Cell Disease Related Priapism

  • STATUS
    Recruiting
  • End date
    Mar 4, 2022
  • participants needed
    56
  • sponsor
    Novartis Pharmaceuticals
Updated on 28 October 2020
Investigator
Novartis Pharmaceuticals
Primary Contact
Children s National Hospital SC (5.3 mi away) Contact
+16 other location

Summary

The goal of the study is to evaluate the efficacy and safety of crizanlizumab in SCD patients with priapism.

Details
Treatment crizanlizumab
Clinical Study IdentifierNCT03938454
SponsorNovartis Pharmaceuticals
Last Modified on28 October 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 16 yrs?
Are you male?
Do you have Priapism?
Male patients aged 16 years and above
Confirmed diagnosis of SCD by hemoglobin electrophoresis or high performance liquid chromatography. All SCD genotypes are eligible (HbSS, HbS0, HbSC, HbS+, and others)
Experienced 4 or more priapic events (unwanted erection lasting at least 60 minutes) over the 14 weeks preceding study participation
Experienced at least 3 priapic events (unwanted erection lasting at least 60 minutes) during the 12 week screening period with at least 1 event occurring within 4 weeks prior to the first treatment
If receiving hydroxyurea/hydroxycarbamide or L-glutamine or erythropoietin stimulating agent, must have been receiving the drug for at least 14 weeks prior to screening and plan to continue taking the drug at the same dose and schedule during the trial
If receiving prophylactic treatment for priapism, must have been receiving the drug for at least 14 weeks prior to screening and plan to continue taking the drug at the same dose and schedule during the trial
Written informed consent (or assent/ parental consent for minor subjects) prior to any screening procedures

Exclusion Criteria

Had penile prosthetic implants or shunts or any other surgical procedure on the penis
Took drugs/medications that may induce priapism over the 14 weeks preceding study entry
Received leuprolide acetate (Lupron) within 3 months before pre-screening
Had an erection lasting more than 12 hours over the 14 week preceding study entry
Had an erection lasting more than 12 hours during the 12 weeks of the screening period
Other protocol-defined inclusion/exclusion criteria may apply
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Step 3 Enroll in the clinical study

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Step 4 Get your study results

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