Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04657822
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Months - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Crizanlizumab — DRUG
    Concentrate for solution for infusion for Intravenous use

Study Details

This is a multi-center multi-national rollover study to allow continued access to crizanlizumab for patients with sickle cell disease (SCD) who are on crizanlizumab treatment in a Novartis-sponsored study (parent study) and are benefiting from the treatment as judged by the investigator.

Key Dates

Start date
Jun 10, 2021
Status verified
Jun 2026
Primary completion
Jun 10, 2031
Completion
Jun 10, 2031

Study Design

Enrollment
130 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Crizanlizumab
    All participants will receive crizanlizumab (SEG101) at the same dose/schedule as in the parent study.

Primary Outcome Measure

Not Applicable as this protocol is to provide an option for continued access to crizanlizumab for patients with Sickle Cell Disease who have completed a prior Novartis-sponsored Crizanlizumab study [ Time Frame: Not Applicable - Study Completion ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

Locations (7)

FacilityCityStateZIPSite coordinators
University Of AlabamaBirminghamAlabama35233
Jeanine Dumas
[email protected]
+1 205 638 2792
Chibuzo Churchill Ilonze (PRINCIPAL_INVESTIGATOR)
Childrens National HospitalWashington D.C.District of Columbia20010-
Augusta University GeorgiaAugustaGeorgia30912
Latanya Bowman
[email protected]
706-721-2171
Abdullah Kutlar (PRINCIPAL_INVESTIGATOR)
East Carolina UniversityGreenvilleNorth Carolina27834-
East Carolina UniversityGreenvilleNorth Carolina27858-
Childrens Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-4399-
Cook Childrens Medical CenterFort WorthTexas76104-

Find similar trials in Birmingham, AL

By condition
Sickle cell disease
By research site
University Of Alabama· Birmingham, ALChildrens National Hospital· Washington D.C., DCAugusta University Georgia· Augusta, GAEast Carolina University· Greenville, NCChildrens Hospital of Philadelphia· Philadelphia, PACook Childrens Medical Center· Fort Worth, TX

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