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NCT00025805 · ClinicalTrials.gov registry record · Phase 1
G-CSF to Treat Crohn's Disease
A Phase 1 study of Crohn's Disease, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT00025805 is a Phase 1 study of Crohn's Disease that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 23 participants, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00025805, a Phase 1 study of Crohn's Disease, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine the effectiveness of G-CSF in treating patients with Crohn's disease-a long-term recurring inflammation of the small and large intestine. Patients may have swelling and bleeding of the intestinal lining, which can lead to infection and abdominal pain, weight loss, fever, diarrhea, bloody stools, fistula (connections between the skin and intestine), intestinal blockages, and abscesses. Although there are various treatments for Crohn's disease, many patients continue to have inflammation that is difficult to control or severe side effects from the medications. G-CSF is an approved drug that is used to increase white blood cell counts. Other cells, immune cells, exposed to G-CSF can develop a specific immune action-a Th-2 response-that decreases the inflammatory response in Crohn's disease-a Th-1 response. Patients 18 years of age or older who have had mild to moderately severe Crohn's disease for at least 4 months may be eligible for this study. Candidates will be screened with a medical history and possible review of medical records, physical examination, blood tests, electrocardiogram (EKG), urine and stool analyses and, for women, a pregnancy test. They will fill out a Crohn's Disease Activity Index questionnaire daily for 7 days and an Inflammatory Bowel Disease questionnaire. Participants will have G-CSF therapy. Before starting therapy, they will have a series of pre-treatment tests, including a colonoscopy and leukapheresis. Colonoscopy is an examination of the colon. For the procedure, patients are given a medication to lessen anxiety and any discomfort. An endoscope-a lighted flexible tube-is inserted into the rectum, allowing examination of the extent of inflammation. The endoscope can also be used to take pictures of the colon and extract tissue samples for testing (biopsy). Leukapheresis is a procedure for collecting quantities of white blood cells. Whole blood is collected through a needle placed in an arm vein and circulated thr
Conditions Studied
Interventions
- DRUG G-CSF
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2001-10-23 |
| Est. Completion | 2008-06-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00025805
The ClinicalTrials.gov registry entry for NCT00025805 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (99% 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 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 1 intervention - of which G-CSF is the first listed.
NCT00025805 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00025805 about?
NCT00025805 is a clinical study titled "G-CSF to Treat Crohn's Disease". This study will examine the effectiveness of G-CSF in treating patients with Crohn's disease-a long-term recurring inflammation of the small and large intestine. Patients may have swelling and bleeding of the intestinal lining, which can lead to infection and abdominal pain, weight loss, fever, diar...
What is the current status of trial NCT00025805?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2001-10-23. Estimated completion is 2008-06-13.
What conditions does trial NCT00025805 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT00025805?
The interventions under investigation include: G-CSF (DRUG).
Who is sponsoring clinical trial NCT00025805?
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 NCT00025805 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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