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

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)

ClinicalTrials.gov Identifier: NCT03938454

Novartis Reference Number: CSEG101AUS05

Last Update: Nov 18, 2021

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Priapism
Phase 
Phase 2
Overall status 
Recruiting
Start date 
Oct 16, 2019
Completion date 
Nov 03, 2023
Gender 
Male
Age(s)
16 Years and older (Child, Adult, Older Adult)

Interventions

Drug
crizanlizumab
Crizanlizumab is a concentrate for solution for infusion, i.v. use. Supplied in single use 10 mL vials at a concentration of 10 mg/mL. One vial contains 100 mg of crizanlizumab

Eligibility Criteria

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

Study Locations

United States
University of Alabama
Recruiting
Birmingham, 35294 - Alabama
Contact: Julie Kanter Washko
United States
University of Connecticut Health Center
Recruiting
Farmington, 06030 - Connecticut
Contact: Biree Andemariam
United States
Children s National Hospital SC
Recruiting
Washington, 20010 - District of Columbia
Contact: (202-476-5546) Robert Nickel
United States
Foundation for Sickle Cell Disease Research
Recruiting
Hollywood, 33021 - Florida
Contact: (954-397-3251) Gershwin Blyden
United States
Emory University School of Medicine/Winship Cancer Institute
Recruiting
Atlanta, 30303 - Georgia
Contact: Morgan L McLemore
United States
Childrens Healthcare of Atlanta
Recruiting
Atlanta, 30342 - Georgia
Contact: Robert Clark Brown
United States
Georgia Health Sciences University
Recruiting
Augusta, 30912 - Georgia
Contact: Abdullah Kutlar
United States
LSU Medical Center
Recruiting
Shreveport, 71130 - Louisiana
Contact: (318-675-5661) Richard Mansour
United States
Childrens Hospital Boston
Recruiting
Boston, 02115 - Massachusetts
Contact: (617-355-7700) Matthew M Heeney
United States
Jacobi Medical Center
Recruiting
Bronx, 10461 - New York
Contact: (718-918-5642) Kenneth Rivlin
United States
Montefiore Medical Center
Recruiting
Bronx, 10461 - New York
Contact: Caterina Minniti
United States
NYC H Hospital Queens Cancer Center
Recruiting
New York, 11432 - New York
Contact: Debra Ferman
United States
Levine Cancer Insitute Carolinas Healthcare System
Recruiting
Charlotte, 28204 - North Carolina
Contact: (980-442-2000) Ifeyinwa Osunkwo
United States
Duke University Medical Center
Recruiting
Durham, 27710 - North Carolina
Contact: Soheir Adam
United States
Brody School of Medicine
Recruiting
Greenville, 27834 - North Carolina
Contact: Darla Liles
United States
University of Pittsburgh
Recruiting
Pittsburgh, 15213-2548 - Pennsylvania
Contact: Laura DeCastro
United States
Medical University of South Carolina
Recruiting
Charleston, 29425 - South Carolina
Contact: (843-792-1815) Shayla Bergmann
United States
University of Texas Medical School CFTY720D2399E1
Recruiting
Houston, 77030 - Texas
Contact: (713-500-7107) Modupe Idowu
United States

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

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