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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: Completed Phase 3 study of Cold Agglutinin Disease, sponsored by Swedish Orphan Biovitrum.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
A participant was considered to have a response if the Hgb level increased greater than or equal to (\>=) 1.5 gram per deciliter (g/dL) from baseline and this increase was maintained from Week 16 through Week 24 in absence of blood transfusion from Week 5 through Week 24.
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 |
What the finished NCT05096403 record still lists
NCT05096403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
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 names 20 study sites across 6 states, led by 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.
Learn More About Clinical Trials
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Where NCT05096403's enrollment target sits among peer trials
24 1943rd of 2000 higher than 49 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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