ClinicalTrials.gov record
Completed Phase 1 Interventional

A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease

ClinicalTrials.gov ID: NCT04269551

Public ClinicalTrials.gov record NCT04269551. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 16, 2026, 11:38 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Phase 1b, Open Label, Nonrandomized, Single Dose Study Evaluating the Safety, Tolerability and Activity of BIVV020 in Adults With Cold Agglutinin Disease

Study identification

NCT ID
NCT04269551
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Bioverativ, a Sanofi company
Industry
Enrollment
12 participants

Conditions and interventions

Interventions

  • BIVV020 Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 14, 2020
Primary completion
Jan 5, 2022
Completion
Jan 5, 2022
Last update posted
Sep 21, 2025

2020 – 2022

United States locations

U.S. sites
5
U.S. states
5
U.S. cities
5
Facility City State ZIP Site status
Investigational Site Number :8400002 Fayetteville Georgia 30214
Investigational Site Number :8400009 St Louis Missouri 63110
Investigational Site Number :8400006 The Bronx New York 10467
Investigational Site Number :8400008 Pittsburgh Pennsylvania 15232
Investigational Site Number :8400004 Seattle Washington 98108

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04269551, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 21, 2025 · Synced May 16, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04269551 live on ClinicalTrials.gov.

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