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NCT04657822 · ClinicalTrials.gov registry record · Phase 4
Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
A Phase 4 study of Sickle Cell Disease, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 130
- Enrollment target
- 20
- Study locations
NCT04657822: Recruiting Phase 4 study of Sickle Cell Disease, sponsored by Novartis Pharmaceuticals.
NCT04657822 is a Phase 4 study of Sickle Cell Disease that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 130 participants, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04657822, a Phase 4 study of Sickle Cell Disease, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 130 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Protocol to provide an option for continued access to crizanlizumab for patients with Sickle Cell Disease who have completed a prior Novartis-sponsored Crizanlizumab study, benefited from the treatment and do not have access to reimbursed, commercially available crizanlizumab.
Conditions Studied
Interventions
- DRUG Crizanlizumab
Study Locations (20)
Other
- Novartis Investigative Site - Brussels
- Novartis Investigative Site - Laken
- Novartis Investigative Site - Liège
- Novartis Investigative Site - Montería
- Novartis Investigative Site - Créteil
- Novartis Investigative Site - Paris
- Novartis Investigative Site - Paris
- Novartis Investigative Site - Heidelberg
North Carolina
- East Carolina University - Greenville
- East Carolina University - Greenville
São Paulo
- Novartis Investigative Site - Ribeirão Preto
- Novartis Investigative Site - São Paulo
Alabama
- University Of Alabama - Birmingham
District of Columbia
- Childrens National Hospital - Washington D.C.
Georgia
- Augusta University Georgia - Augusta
Pennsylvania
- Childrens Hospital of Philadelphia - Philadelphia
Texas
- Cook Childrens Medical Center - Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2021-06-10 |
| Est. Completion | 2031-06-10 |
| Phase | Phase 4 |
What NCT04657822 shows while recruiting
NCT04657822 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 1 intervention - of which Crizanlizumab is the first listed.
NCT04657822 names 20 study sites across 11 states, led by Other, North Carolina, São Paulo.
Frequently Asked Questions
What is clinical trial NCT04657822 about?
NCT04657822 is a clinical study titled "Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study". 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.
What is the current status of trial NCT04657822?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 130 participants. The study started on 2021-06-10. Estimated completion is 2031-06-10.
What conditions does trial NCT04657822 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT04657822?
The interventions under investigation include: Crizanlizumab (DRUG).
Who is sponsoring clinical trial NCT04657822?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04657822 being conducted?
This trial has 20 study locations across Alabama, District of Columbia, Georgia, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04657822's enrollment target sits among peer trials
130 48th of 213 higher than 165 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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