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NCT00278512 · ClinicalTrials.gov registry record · Phase 1
Hematopoietic Stem Cell Support in Vasculitis
A Phase 1 study, sponsored by Northwestern University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT00278512 is a Phase 1 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 7 participants.
The verdict
NCT00278512, a Phase 1 study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
The systemic vasculitis is a wide-ranging group of diseases that are characterized by the presence of blood vessel inflammation (1). Despite this common feature, each type of vasculitis has a unique variety of clinical manifestations that influences its degree of disease severity and ultimately its management. Immunosuppressive therapy forms the foundation of treatment for almost all forms of systemic vasculitis. The systemic necrotizing vasculitis (SNV) are a subset of vasculitis with significant morbidity and mortality (2). The SNV are Wegener's granulomatosis, allergic angiitis and granulomatosis (AAG) (also known as Churg-Strauss syndrome), polyarteritis nodosum (PAN), microscopic polyangiitis (MPA), and overlap syndrome. In spite of modern therapeutic immune suppressive agents, there remains a not inconsequential morbidity and mortality associated with SNV. The current standard therapy for SNV is chronic oral cyclophosphamide (1-3 mg/kg/day) and corticosteroids (3-6). Transplant doses of cyclophosphamide at 200 mg/kg infused over 4 days is the most common worldwide transplant regimen for systemic lupus erythematosus (SLE) (7). Like SLE, SNV are cyclophosphamide responsive disease. We, therefore, propose a trial of high dose cyclophosphamide with anti-thymocyte globulin (ATG) for patients with SNV.
Interventions
- DRUG Cyclophosphamide
- DRUG G-CSF
- BIOLOGICAL Allogeneic Stem Cell Transplant
- BIOLOGICAL Autologous Stem Cell Transplant
- DRUG ATG (rabbit)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2003-08 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00278512
The ClinicalTrials.gov registry entry for NCT00278512 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00278512 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00278512 about?
NCT00278512 is a clinical study titled "Hematopoietic Stem Cell Support in Vasculitis". The systemic vasculitis is a wide-ranging group of diseases that are characterized by the presence of blood vessel inflammation (1). Despite this common feature, each type of vasculitis has a unique variety of clinical manifestations that influences its degree of disease severity and ultimately its ...
What is the current status of trial NCT00278512?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2003-08. Estimated completion is 2016-06.
What interventions are being tested in trial NCT00278512?
The interventions under investigation include: Cyclophosphamide (DRUG), G-CSF (DRUG), Allogeneic Stem Cell Transplant (BIOLOGICAL), Autologous Stem Cell Transplant (BIOLOGICAL), ATG (rabbit) (DRUG).
Who is sponsoring clinical trial NCT00278512?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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