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NCT00468208 · ClinicalTrials.gov registry record · Phase 1
Abatacept in Treating Adults With Mild Relapsing Wegener's Granulomatosis
A Phase 1 study of Wegener's Granulomatosis, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 4
- Study locations
NCT00468208: Completed Phase 1 study of Wegener's Granulomatosis, sponsored by University of Pennsylvania.
NCT00468208 is a Phase 1 study of Wegener's Granulomatosis that has completed, run by University of Pennsylvania. The registered enrollment target is 20 participants, below the 72-participant average among 7 other Wegener's Granulomatosis trials with a reported enrollment target (72% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00468208, a Phase 1 study of Wegener's Granulomatosis, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 4
- Study locations
Study Summary
Wegener's granulomatosis (WG) is a rare disease that causes inflammation of blood vessels, or vasculitis. It may involve many different parts of the body, but typically affects the upper and lower respiratory tract and kidneys. The purpose of this study is to determine the safety and effectiveness of the medication abatacept in treating adults with mild relapsing WG.
Primary Outcome
This study examined the safety profile of this agent when used in Wegener's granulomatosis. Information was gathered on all adverse events with specific events being identified in the protocol for analysis that included the following: * Infection * Infusion reactions * Cytopenias * Transaminase elevation * Skin reactions * GI side effects * Malignancy All adverse events were reportable for this study.
Conditions Studied
Interventions
- DRUG Abatacept
Study Locations (4)
Maryland
- The Johns Hopkins Vasculitis Center - Baltimore
Massachusetts
- Boston University School of Medicine - Boston
Minnesota
- Mayo Clinic College of Medicine - Rochester
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2008-02 |
| Est. Completion | 2011-08 |
| Phase | Phase 1 |
What the finished NCT00468208 record still lists
NCT00468208 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 72-participant average among 7 other Wegener's Granulomatosis trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Wegener's Granulomatosis appearing as the primary indexed condition, and to 1 intervention - of which Abatacept is the first listed.
NCT00468208 reports a single indexed study location in Maryland, Massachusetts, Minnesota.
Frequently Asked Questions
What is clinical trial NCT00468208 about?
NCT00468208 is a clinical study titled "Abatacept in Treating Adults With Mild Relapsing Wegener's Granulomatosis". Wegener's granulomatosis (WG) is a rare disease that causes inflammation of blood vessels, or vasculitis. It may involve many different parts of the body, but typically affects the upper and lower respiratory tract and kidneys. The purpose of this study is to determine the safety and effectiveness o...
What is the current status of trial NCT00468208?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2008-02. Estimated completion is 2011-08.
What conditions does trial NCT00468208 study?
This clinical trial studies the following conditions: Wegener's Granulomatosis.
What interventions are being tested in trial NCT00468208?
The interventions under investigation include: Abatacept (DRUG).
Who is sponsoring clinical trial NCT00468208?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00468208 being conducted?
This trial has 4 study locations across Maryland, Massachusetts, Minnesota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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