Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04269551 · ClinicalTrials.gov registry record · Phase 1
A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease
A Phase 1 study, sponsored by Bioverativ, a Sanofi company.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT04269551 is a Phase 1 study that has completed, run by Bioverativ, a Sanofi company. The registered enrollment target is 12 participants.
The verdict
NCT04269551, a Phase 1 study, has completed, sponsored by Bioverativ, a Sanofi company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Primary Objective: To assess the safety and tolerability in participants with cold agglutinin disease (CAD), after a single dose of intravenous (IV) BIVV020 Secondary Objectives: To assess, in participants with cold agglutinin disease, after a single dose of intravenous (IV) BIVV020: * The effect of BIVV020 on complement mediated hemolysis * The pharmacodynamics (PD) of BIVV020 relating to complement inhibition * The pharmacokinetics (PK) of BIVV020 * The immunogenicity of BIVV020
Interventions
- DRUG BIVV020
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-06-15 |
| Est. Completion | 2022-01-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04269551
The ClinicalTrials.gov registry entry for NCT04269551 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bioverativ, a Sanofi company, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BIVV020 is the first listed.
NCT04269551 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04269551 about?
NCT04269551 is a clinical study titled "A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease". Primary Objective: To assess the safety and tolerability in participants with cold agglutinin disease (CAD), after a single dose of intravenous (IV) BIVV020 Secondary Objectives: To assess, in participants with cold agglutinin disease, after a single dose of intravenous (IV) BIVV020: * The effec...
What is the current status of trial NCT04269551?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2020-06-15. Estimated completion is 2022-01-06.
What interventions are being tested in trial NCT04269551?
The interventions under investigation include: BIVV020 (DRUG).
Who is sponsoring clinical trial NCT04269551?
This trial is sponsored by Bioverativ, a Sanofi company, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.