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NCT06831058 · ClinicalTrials.gov registry record · Phase 2
A Pilot Study of Efgartigimod for Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)
A Phase 2 study of Immune-mediated Thrombotic Thrombocytopenic Purpura, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT06831058 is a Phase 2 study of Immune-mediated Thrombotic Thrombocytopenic Purpura that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 15 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06831058, a Phase 2 study of Immune-mediated Thrombotic Thrombocytopenic Purpura, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Immune-mediated Thrombotic thrombocytopenic purpura (iTTP) is a rare, autoimmune disorder characterized by life-threatening episodes of thrombocytopenia, microangiopathic hemolytic anemia and organ damage. Patients have an unpredictable course punctuated by relapses associated with autoantibody-mediated (primarily IgG) depletion of ADAMTS13, a key regulator of coagulation. ADAMTS13 deficiency during remission has been associated with increased risk of relapse, but also, and potentially more devastating, ischemic stroke. Until recently, it was presumed that rituximab (a monoclonal antibody targeting B cells) improved relapse-free survival in most patients, but this was based on findings from very small studies. Given concern about stroke and relapse risk, preventive immunosuppression with rituximab has also recently come into practice for patients with falling ADAMTS13 activity (ADAMTS13-relapse). It is expected that following efgartigimod therapy, there will be a rise in ADAMTS13 activity to the normal range that will be sustained during the treatment period. Following withdrawal of therapy, it is expected that most participants will experience a fall in ADAMTS13 activity, demonstrating the safety and efficacy in efgartigimod to reliably but temporarily reduce pathogenic antibodies. This would demonstrate the potential efficacy for efgartigimod as a maintenance therapy to safely prevent relapse of iTTP to be further explored in a larger efficacy study.
Conditions Studied
Interventions
- DRUG efgartigimod
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-05-01 |
| Est. Completion | 2028-05-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06831058
The ClinicalTrials.gov registry entry for NCT06831058 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Immune-mediated Thrombotic Thrombocytopenic Purpura appearing as the primary indexed condition, and to 1 intervention - of which efgartigimod is the first listed.
NCT06831058 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT06831058 about?
NCT06831058 is a clinical study titled "A Pilot Study of Efgartigimod for Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)". Immune-mediated Thrombotic thrombocytopenic purpura (iTTP) is a rare, autoimmune disorder characterized by life-threatening episodes of thrombocytopenia, microangiopathic hemolytic anemia and organ damage. Patients have an unpredictable course punctuated by relapses associated with autoantibody-medi...
What is the current status of trial NCT06831058?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2025-05-01. Estimated completion is 2028-05-01.
What conditions does trial NCT06831058 study?
This clinical trial studies the following conditions: Immune-mediated Thrombotic Thrombocytopenic Purpura.
What interventions are being tested in trial NCT06831058?
The interventions under investigation include: efgartigimod (DRUG).
Who is sponsoring clinical trial NCT06831058?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06831058 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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