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NCT05791708 · ClinicalTrials.gov registry record

Cold Agglutinin Disease Real World Evidence Registry

A clinical trial of Cold Agglutinin Disease (CAD) and Cold Agglutinin Syndrome (CAS), sponsored by Recordati Group.

Recruiting
Registry status
400
Enrollment target
20
Study locations

NCT05791708 is a study of Cold Agglutinin Disease (CAD) and Cold Agglutinin Syndrome (CAS) that is actively recruiting participants, run by Recordati Group. The registered enrollment target is 400 participants. The trial reports 20 study locations across 16 states.

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The verdict

NCT05791708, a study of Cold Agglutinin Disease (CAD) and Cold Agglutinin Syndrome (CAS), is actively recruiting participants, sponsored by Recordati Group.

RECRUITING
Registry status
400 participants
Enrollment target
20
Study locations

Study Summary

This is a multinational, multi-center, observational, prospective, longitudinal disease registry designed to collect data on participants with cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS). Among them, a minimum of 30 patients with CAD treated with sutimlimab are expected to take part in the sutimlimab cohort study. Patients with CAD who have been enrolled in previous sutimlimab clinical trials (e.g., BIVV009-01/LTS16214 \[NCT02502903,CAD patients\], BIVV009-03/EFC16215 \[NCT03347396\], and BIVV009-04/EFC16216 \[NCT03347422\]) and who either completed or discontinued the corresponding clinical trial are eligible to participate in the registry.

Interventions

  • DRUG Sutimlimab

Study Locations (20)

New York

  • Northwell Health-Monter Cancer Center-North Shore University Hospital and Steven and Alexandra Cohen Children's Medical Center of New York (Schneider Children's Hospital)-North Shore Long Island Jewis Site Number : 1231 - Lake Success
  • Center for Blood Disorders Site Number : 1214 - New York
  • SUNY Upstate Medical University Site Number : 1221 - Syracuse

California

  • SLO Oncology and Hematology Site Number : 1235 - San Luis Obispo
  • Mission Hope Medical Oncology Site Number : 1241 - Santa Maria

Ohio

  • Cleveland Clinic Foundation Site Number : 1207 - Cleveland
  • The Ohio State University Site Number : 1236 - Columbus

Alabama

  • University of Alabama at Birmingham Site Number : 1230 - Birmingham

District of Columbia

  • MedStar Georgetown University Hospital / Lombardi Comprehensive Cancer Center Site Number : 1208 - Washington D.C.

Georgia

  • Piedmont Cancer Institute, P.C Site Number : 1226 - Atlanta

Illinois

  • Orchard Heathcare Research Inc. Site Number : 1202 - Skokie

Iowa

  • Siouxland Regional Cancer Center dba June E. Nylen Cancer Center Site Number : 1220 - Sioux City

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2019-12-12
Est. Completion 2028-11-02

Sponsor

Recordati Group

11 total trials

What the Registry Record Tells You About NCT05791708

The ClinicalTrials.gov registry entry for NCT05791708 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Recordati Group, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Cold Agglutinin Disease (CAD) appearing as the primary indexed condition, and to 1 intervention - of which Sutimlimab is the first listed.

NCT05791708 reports 20 study locations spanning 16 distinct geographic areas - top geographies include New York, California, Ohio.

Frequently Asked Questions

What is clinical trial NCT05791708 about?

NCT05791708 is a clinical study titled "Cold Agglutinin Disease Real World Evidence Registry". This is a multinational, multi-center, observational, prospective, longitudinal disease registry designed to collect data on participants with cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS). Among them, a minimum of 30 patients with CAD treated with sutimlimab are expected to take p...

What is the current status of trial NCT05791708?

This trial is currently recruiting. The enrollment target is 400 participants. The study started on 2019-12-12. Estimated completion is 2028-11-02.

What conditions does trial NCT05791708 study?

This clinical trial studies the following conditions: Cold Agglutinin Disease (CAD), Cold Agglutinin Syndrome (CAS).

What interventions are being tested in trial NCT05791708?

The interventions under investigation include: Sutimlimab (DRUG).

Who is sponsoring clinical trial NCT05791708?

This trial is sponsored by Recordati Group, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05791708 being conducted?

This trial has 20 study locations across Alabama, California, District of Columbia, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.