October, 10 2019

A Prospective Phase II, Open-Label, Single-arm, Multicenter, Study to Assess Efficacy and Safety of SEG101 (Crizanlizumab), in Sickle Cell Disease Patients With Priapism (SPARTAN)

Locations

2 United States sites

Age

> 16 Years

Phase

Phase 2

About the study

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

Study Type

Interventional

Phase

Phase 2

Age

> 16 Years

Gender

Male

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, HbSβ0, HbSC, HbSβ+, 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

Interventions

  • Drug

Outcome measures

  • Percent change in priapic events from baseline to 26 weeks

Location

  • University of Alabama, Birmingham, Alabama, United States, 35294 [Recruiting]
  • Greenville Health System, Greenville, South Carolina, United States, 29615 [Recruiting]

Contact Research Team

  • Novartis Pharmaceuticals
  • Novartis Pharmaceuticals
    1-888-669-6682

More info

View on ClinicalTrials
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