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

  • STATUS
    Recruiting
  • End date
    Nov 3, 2023
  • participants needed
    56
  • sponsor
    Novartis Pharmaceuticals
Updated on 15 February 2022

Summary

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

Details
Condition Priapism
Treatment crizanlizumab
Clinical Study IdentifierNCT03938454
SponsorNovartis Pharmaceuticals
Last Modified on15 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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