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NCT00001761 · ClinicalTrials.gov registry record · Phase 1
Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients With Wegener's Granulomatosis
A Phase 1 study of Vasculitis and Wegener's Granulomatosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT00001761 is a Phase 1 study of Vasculitis and Wegener's Granulomatosis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 15 participants, below the 27,317-participant average among 11 other Vasculitis trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00001761, a Phase 1 study of Vasculitis and Wegener's Granulomatosis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess the safety, tolerance, and immunologic effects of interleukin-10 (IL-10), in patients with Wegener's granulomatosis. A secondary objective is to determine if IL-10 demonstrates sufficient anti-inflammatory activity in the treatment of Wegener's granulomatosis to warrant further study in a larger trial. In this study, IL-10 will be given either alone or in combination with standard therapeutic agents, usually consisting of cyclophosphamide, methotrexate, and/or prednisone. Patients will be eligible to receive IL-10 when there is evidence of active disease. IL-10 will be administered by subcutaneous injection at a dose of 4 µ (Micro)g/kg/day for 28 days.
Conditions Studied
Interventions
- DRUG Interleukin-10
Study Locations (1)
Maryland
- National Institute of Allergy and Infectious Diseases (NIAID) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 1998-02 |
| Est. Completion | 2000-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001761
The ClinicalTrials.gov registry entry for NCT00001761 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 27,317-participant average among 11 other Vasculitis trials with a reported enrollment target (100% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Vasculitis appearing as the primary indexed condition, and to 1 intervention - of which Interleukin-10 is the first listed.
NCT00001761 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00001761 about?
NCT00001761 is a clinical study titled "Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients With Wegener's Granulomatosis". The purpose of this study is to assess the safety, tolerance, and immunologic effects of interleukin-10 (IL-10), in patients with Wegener's granulomatosis. A secondary objective is to determine if IL-10 demonstrates sufficient anti-inflammatory activity in the treatment of Wegener's granulomatosis t...
What is the current status of trial NCT00001761?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 1998-02. Estimated completion is 2000-04.
What conditions does trial NCT00001761 study?
This clinical trial studies the following conditions: Vasculitis, Wegener's Granulomatosis.
What interventions are being tested in trial NCT00001761?
The interventions under investigation include: Interleukin-10 (DRUG).
Who is sponsoring clinical trial NCT00001761?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001761 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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