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NCT04935879 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises
A Phase 3 study of Sickle Cell Disease and Vaso-occlusive Crisis, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 241
- Enrollment target
- 20
- Study locations
NCT04935879: Completed Phase 3 study of Sickle Cell Disease and Vaso-occlusive Crisis, sponsored by Pfizer.
NCT04935879 is a Phase 3 study of Sickle Cell Disease and Vaso-occlusive Crisis that has completed, run by Pfizer. The registered enrollment target is 241 participants, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (17% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04935879, a Phase 3 study of Sickle Cell Disease and Vaso-occlusive Crisis, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 241 participants
- Enrollment target
- 20
- Study locations
Study Summary
This Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs) in approximately 240 adult and adolescent participants (≥ 12 years of age) with sickle cell disease (SCD). Participants will be randomized to receive inclacumab or placebo.
Primary Outcome
A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral nonsteroidal anti-inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics. The rate of VOC was defined as
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Inclacumab
Study Locations (20)
Illinois
- Hospital Pharmacy Services- Investigational Drug Services - Chicago
- Rush University Medical Center Investigator Pharmacy - Chicago
- Rush University Medical Center - Chicago
- University of Illinois Clinical Research Center (CRC) - Chicago
- University of Illinois Hospital and Health Sciences System(UI Health) - Chicago
Alabama
- University of South Alabama Children's and Women's Hospital - Mobile
- University of South Alabama Mitchell Cancer Institute - Mobile
- University of South Alabama Strada Patient Care Center - Mobile
California
- UC Irvine Health - Orange
- UCI Center for clinical research - Orange
Massachusetts
- Dana-Farber Cancer Institute IDS Pharmacy - Boston
- Dana-Farber Cancer Institute - Boston
North Carolina
- Duke University Medical Center - Durham
- DUMC Investigational Drug Services Pharmacy - Durham
Texas
- McGovern Medical School/Health Science Center Houston - Houston
- Memorial Hermann - TMC Investigational Drugs, IDS Pharmacy - Houston
Arkansas
- Arkansas Children's Hospital - Little Rock
Connecticut
- Uconn Health/Uconn John Dempsey Hospital/Neag Comprehensive Cancer Center/New England Sickle Cell - Farmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2021-10-04 |
| Est. Completion | 2024-06-06 |
| Phase | Phase 3 |
What the finished NCT04935879 record still lists
NCT04935879 is an interventional study that assigns participants to a tested intervention. The registered 241 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 (17% lower).
The record links to 3 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04935879 names 20 study sites across 10 states, led by Illinois, Alabama, California.
Frequently Asked Questions
What is clinical trial NCT04935879 about?
NCT04935879 is a clinical study titled "A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises". This Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs) in approximately 240 adult and adolescent participants (≥ 12 years of age) with sickle cell disease (SCD). Participants will be randomized to receiv...
What is the current status of trial NCT04935879?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 241 participants. The study started on 2021-10-04. Estimated completion is 2024-06-06.
What conditions does trial NCT04935879 study?
This clinical trial studies the following conditions: Sickle Cell Disease, Vaso-occlusive Crisis, Vaso-Occlusive Pain Episode in Sickle Cell Disease.
What interventions are being tested in trial NCT04935879?
The interventions under investigation include: Placebo (DRUG), Inclacumab (DRUG).
Who is sponsoring clinical trial NCT04935879?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04935879 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Connecticut, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04935879's enrollment target sits among peer trials
241 30th of 213 higher than 184 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.
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