Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT04269551
Brief 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
Detailed Description:
Up to 23 weeks (screening period up to 8 weeks, treatment period 15 weeks)
Study:
NCT04269551
Study Brief:
Protocol Section:
NCT04269551