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NCT03814746 · ClinicalTrials.gov registry record · Phase 3
Study of Two Doses of Crizanlizumab Versus Placebo in Adolescent and Adult Sickle Cell Disease Patients
A Phase 3 study of Sickle Cell Disease (SCD), sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 255
- Enrollment target
- 20
- Study locations
NCT03814746: Active Phase 3 study of Sickle Cell Disease (SCD), sponsored by Novartis Pharmaceuticals.
NCT03814746 is a Phase 3 study of Sickle Cell Disease (SCD) that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 255 participants, below the 351-participant average among 4 other Sickle Cell Disease (SCD) trials with a reported enrollment target (27% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03814746, a Phase 3 study of Sickle Cell Disease (SCD), is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 255 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult sickle cell disease (SCD) patients with history of vaso-occlusive crisis (VOC) leading to healthcare visit.
Primary Outcome
VOC is defined as pain crisis (defined as an acute onset of pain for which there is no other medically determined explanation other than vaso-occlusion) which requires therapy with oral or parenteral opioids or parenteral NSAID as well as other complicated crisis such as acute chest syndrome (ACS), priapism and hepatic or splenic sequestration. Healthcare visit is defined as any visit to a medical facility such as emergency room (ER), hospital and/or office visit, which includes pain management
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Crizanlizumab (SEG101)
Study Locations (20)
São Paulo
- Novartis Investigative Site - Ribeirão Preto
- Novartis Investigative Site - São Paulo
- Novartis Investigative Site - São Paulo
- Novartis Investigative Site - São Paulo
Other
- Novartis Investigative Site - Brussels
- Novartis Investigative Site - Edegem
Georgia
- Childrens Healthcare of Atlanta - Atlanta
Massachusetts
- Boston Medical Center - Boston
North Carolina
- Levine Cancer Insitute Carolinas Healthcare System - Charlotte
Tennessee
- Univ of Tenn Health Sciences Ctr - Memphis
Texas
- U of TX Health Science Ct - Houston
Brussels Capital
- Novartis Investigative Site - Brussels
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 255 participants |
| Start Date | 2019-07-26 |
| Est. Completion | 2026-11-23 |
| Phase | Phase 3 |
What the registry record for NCT03814746 still lists
NCT03814746 is an interventional study that assigns participants to a tested intervention. The registered 255 participants enrollment target is mid-sized for trials with a published cap, below the 351-participant average among 4 other Sickle Cell Disease (SCD) trials with a reported enrollment target (27% lower).
The record links to 1 condition, with Sickle Cell Disease (SCD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03814746 names 20 study sites across 16 states, led by São Paulo, Other, Georgia.
Frequently Asked Questions
What is clinical trial NCT03814746 about?
NCT03814746 is a clinical study titled "Study of Two Doses of Crizanlizumab Versus Placebo in Adolescent and Adult Sickle Cell Disease Patients". The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult sickle cell disease (SCD) patients with history of vaso-occlusive crisis (VOC) leading to healthcare visit.
What is the current status of trial NCT03814746?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 255 participants. The study started on 2019-07-26. Estimated completion is 2026-11-23.
What conditions does trial NCT03814746 study?
This clinical trial studies the following conditions: Sickle Cell Disease (SCD).
What interventions are being tested in trial NCT03814746?
The interventions under investigation include: Placebo (DRUG), Crizanlizumab (SEG101) (DRUG).
Who is sponsoring clinical trial NCT03814746?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03814746 being conducted?
This trial has 20 study locations across Georgia, Massachusetts, North Carolina, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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