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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03938454
Other study ID # CSEG101AUS05
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 16, 2019
Est. completion date November 29, 2023

Study information

Verified date April 2024
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date November 29, 2023
Est. primary completion date March 28, 2023
Accepts healthy volunteers No
Gender Male
Age group 16 Years and older
Eligibility 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, HbSß0, HbSC, HbSß+, 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 or voxelotor, 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 performed within 12 months prior to consenting are not allowed - 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Emory University School of Medicine . Atlanta Georgia
United States University Of Alabama . Birmingham Alabama
United States Childrens Hospital Boston Boston Massachusetts
United States Montefiore Medical Center . Bronx New York
United States Duke University Medical Center . Durham North Carolina
United States University of Connecticut Health Center . Farmington Connecticut
United States Brody School of Medicine . Greenville North Carolina
United States Prisma Health Upstate . Greenville South Carolina
United States Foundation for Sickle Cell Disease Research Hollywood Florida
United States University of Texas Medical School CFTY720D2399E1 Houston Texas
United States University of Pittsburgh . Pittsburgh Pennsylvania
United States LSU Medical Center Shreveport Louisiana
United States Childrens National Hospital SC Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent change in priapic events from baseline to 26 weeks Priapism is defined as an unwanted or painful penile erection lasting at least 60 minutes. The end of the priapic event will be the duration when the unwanted erection has resolved. This event will be self-reported via an electronic reporting system, and this data should be collected throughout the study period. Baseline up to 26 weeks
Secondary Rate of priapic events The rate of priapic events is defined as the total number of priapic events for a subject occurring from the date of initial infusion to the last contact date of the Treatment Phase Baseline up to 26 and 52 weeks
Secondary Percent change in acute priapic events from baseline to 26 weeks An acute priapic event is defined as an unwanted, painful erection that lasts more than 4 hours and need a visit to emergency room. Baseline up to 26 and 52 weeks
Secondary Rate of uncomplicated vaso-occlusive crises The number of uncomplicated VOC events (defined as an acute event of pain with no known cause for pain other than a vaso occlusive event; and requiring treatment with a parenteral or oral opioids or other parenteral analgesic; but is NOT classified as an acute chest syndrome, hepatic sequestration, splenic sequestration or priapism). Events include both healthcare and self-reported events. Baseline up to 26 and 52 weeks
Secondary Rate of complicated vaso-occlusive crises The number of complicated VOCs (defined as acute chest syndrome, hepatic sequestration, splenic sequestration, and acute priapism) recorded by healthcare visit. Baseline up to 26 and 52 weeks
See also
  Status Clinical Trial Phase
Withdrawn NCT00538564 - Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia Phase 2
Withdrawn NCT01940718 - Androgen Regulation of Priapism in Sickle Cell Disease N/A
Terminated NCT00940901 - Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia Phase 2
Enrolling by invitation NCT04932902 - ManAgement of pRiapiSm and Its Impact on Outcomes
Completed NCT00300235 - Priapism in Boys and Men With Sickle Cell Disease - Demographics, Characteristics and Prevalence