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Cold Agglutinin Disease Real World Evidence Registry
NCT05791708 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2019-12-12 |
| Est. Completion | 2028-11-02 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05791708
The ClinicalTrials.gov registry entry for NCT05791708 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05791708 reports 20 study locations spanning 16 distinct geographic areas — top geographies include New York, California, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05791708?
The interventions under investigation include: Sutimlimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05791708?
This trial is sponsored by RECORDATI GROUP, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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