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NCT04817670 · ClinicalTrials.gov registry record · Phase 2
Study to Assess Efficacy and Safety of VIT-2763 (Vamifeport) in Subjects With Sickle Cell Disease
A Phase 2 study of Sickle Cell Disease, sponsored by Vifor (International).
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 20
- Study locations
NCT04817670: Completed Phase 2 study of Sickle Cell Disease, sponsored by Vifor (International).
NCT04817670 is a Phase 2 study of Sickle Cell Disease that has completed, run by Vifor (International). The registered enrollment target is 25 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04817670, a Phase 2 study of Sickle Cell Disease, has completed, sponsored by Vifor (International).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to investigate the effect of VIT-2763 on markers of hemolysis (breakdown in red blood cells) in sickle cell disease (SCD). The safety, tolerability and clinical beneficial effects of VIT-2763 for the treatment of SCD are also explored.
Primary Outcome
Mean change from baseline in haemolysis markers was measured by reduction of indirect bilirubin.
Conditions Studied
Interventions
- DRUG Placebo BID
- DRUG VIT-2763 120 mg
- DRUG VIT-2763 360 mg
- DRUG VIT-2763 240 mg
- DRUG Placebo TID
Study Locations (20)
Other
- Investigator Site 801 - Colombes
- Investigator Site 802 - Lyon
- Investigator Site 305 - Athens
- Investigator site 301 - Athens
- Investigator Site 302 - Pátrai
- Investigator Site 101 - Baabda
- Investigator Site 102 - Beirut
- Investigator Site 103 - Tripoli
- Investigator Site 606 - Liverpool
- Investigator Site 603 - London
- Investigator Site 608 - London
- Investigator Site 601 - London
Alabama
- Investigator Site 709 - Birmingham
California
- Investigator Site 708 - Los Angeles
Colorado
- Investigator Site 713 - Aurora
Florida
- Investigator Site 706 - Hollywood
Illinois
- Investigator Site 703 - Chicago
North Carolina
- Investigator Site 701 - Greenville
South Carolina
- Investigator Site 711 - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2021-11-18 |
| Est. Completion | 2024-03-07 |
| Phase | Phase 2 |
What the finished NCT04817670 record still lists
NCT04817670 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 5 interventions - of which Placebo BID is the first listed.
NCT04817670 names 20 study sites across 9 states, led by Other, Alabama, California.
Frequently Asked Questions
What is clinical trial NCT04817670 about?
NCT04817670 is a clinical study titled "Study to Assess Efficacy and Safety of VIT-2763 (Vamifeport) in Subjects With Sickle Cell Disease". The purpose of this study is to investigate the effect of VIT-2763 on markers of hemolysis (breakdown in red blood cells) in sickle cell disease (SCD). The safety, tolerability and clinical beneficial effects of VIT-2763 for the treatment of SCD are also explored.
What is the current status of trial NCT04817670?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2021-11-18. Estimated completion is 2024-03-07.
What conditions does trial NCT04817670 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT04817670?
The interventions under investigation include: Placebo BID (DRUG), VIT-2763 120 mg (DRUG), VIT-2763 360 mg (DRUG), VIT-2763 240 mg (DRUG), Placebo TID (DRUG).
Who is sponsoring clinical trial NCT04817670?
This trial is sponsored by Vifor (International), which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04817670 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04817670's enrollment target sits among peer trials
25 153rd of 213 higher than 55 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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