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A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD)
NCT05096403 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of the study is to determine the efficacy of pegcetacoplan administration compared to placebo in increasing hemoglobin (Hgb) level from baseline and avoiding transfusion in participants with primary cold agglutinin disease (CAD).
Conditions Studied
Interventions
- DRUG Pegcetacoplan
- DRUG Placebo matching Pegcetacoplan
Study Locations (20)
Other
- Medical University — Vienna
- Algemeen Ziekenhuis Klina — Brasschaat
- UZ Gasthuisberg — Leuven
- CHU de Liège — Liège
- St. Michael's Hospital — Toronto
- Helsinki University Hospital - Comprehensive Cancer Center — Helsinki
- "LTD Medinvest Institute of Hematology and Transfusiology " — Tbilisi
- Ltd M. Zodelava Hematology Centre — Tbilisi
- Universitätsklinikum Essen Klinik f. Hämatologie - Westdeutsches Tumorzentrum — Essen
- Institut f. Transfusionsmedizin - Universität Ulm — Ulm
- Semmelweis Egyetem — Budapest
- A.O.R.N. S.G. Moscati di Avellino — Avellino
- ASST degli Spedali Civili di Brescia_Presidio Ospedaliero di Brescia_U.O. Ematologia — Brescia
- "FOND IRCCS Cà Granda Ospedale Maggiore Policlinico — Milan
- AOU Maggiore della Carità SCDU Ematologia — Novara
California
- The Oncology Institute of Hope and Innovation — Whittier
Florida
- Lakes Research — Miami Lakes
Iowa
- University of Iowa Hospitals & Clinics - The Hemophilia Treatment Center (HTC) — Iowa City
New York
- Weill Cornell Medicine / NewYork Presbyterian Hospital — New York
North Carolina
- East Carolina University Division of Hematology/ Oncology — Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-10-20 |
| Est. Completion | 2024-09-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05096403
The ClinicalTrials.gov registry entry for NCT05096403 describes a study currently listed as completed. It is categorized as Phase 3, 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 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Swedish Orphan Biovitrum, which has 38 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Cold Agglutinin Disease appearing as the primary indexed condition, and to 2 interventions — of which Pegcetacoplan 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: NCT05096403 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Other, California, Florida. 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 NCT05096403 about?
NCT05096403 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD)". The purpose of the study is to determine the efficacy of pegcetacoplan administration compared to placebo in increasing hemoglobin (Hgb) level from baseline and avoiding transfusion in participants with primary cold agglutinin disease (CAD).
What is the current status of trial NCT05096403?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2022-10-20. Estimated completion is 2024-09-11.
What conditions does trial NCT05096403 study?
This clinical trial studies the following conditions: Cold Agglutinin Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05096403?
The interventions under investigation include: Pegcetacoplan (DRUG), Placebo matching Pegcetacoplan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05096403?
This trial is sponsored by Swedish Orphan Biovitrum, which has 38 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05096403 being conducted?
This trial has 20 study locations across California, Florida, Iowa, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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