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NCT05096403 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD)
A Phase 3 study of Cold Agglutinin Disease, sponsored by Swedish Orphan Biovitrum.
- Completed
- Registry status
- Phase 3
- Development phase
- 24
- Enrollment target
- 20
- Study locations
NCT05096403 is a Phase 3 study of Cold Agglutinin Disease that has completed, run by Swedish Orphan Biovitrum. The registered enrollment target is 24 participants. The trial reports 20 study locations across 6 states.
The verdict
NCT05096403, a Phase 3 study of Cold Agglutinin Disease, has completed, sponsored by Swedish Orphan Biovitrum.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 24 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. 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 23 total studies on file at ClinicalTrials.gov.
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.
NCT05096403 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Other, California, Florida.
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.
What interventions are being tested in trial NCT05096403?
The interventions under investigation include: Pegcetacoplan (DRUG), Placebo matching Pegcetacoplan (DRUG).
Who is sponsoring clinical trial NCT05096403?
This trial is sponsored by Swedish Orphan Biovitrum, which has 23 total clinical trials registered on ClinicalTrials.gov.
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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