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NCT01893775 · ClinicalTrials.gov registry record · Phase 1
Antibody Treatment for Advanced Celiac Disease
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT01893775: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01893775 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01893775, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Background: \- Celiac disease is a condition where the immune system attacks the cells of the small intestine. The intestine becomes inflamed and cannot digest food properly. The disease most often causes a reaction to foods that contain gluten. Most people can treat celiac disease with a gluten-free diet. However, some people have digestion problems even on a gluten-free diet. Researchers want to try a new antibody therapy for celiac disease. The treatment may block the immune reaction that causes the disease. They will test this antibody in people who have celiac disease that has not responded to a gluten-free diet. Objectives: \- To see if antibody therapy is a safe and effective treatment for celiac disease that has not responded to standard treatments. Eligibility: \- Individuals at least 18 years of age who have been on a gluten-free diet for 6 to 12 months but still have symptoms of celiac disease. Design: * Participants will be screened with a physical exam and medical history. Blood samples will be collected. These samples will help determine if the specific antibody treatment is likely to work. * Before the start of the study, participants will have a biopsy of the small intestine. * Participants will receive three doses of the study antibody as injections. These doses will be given 3 weeks apart. * Treatment will be monitored with blood tests and heart function tests. Participants will also have a second small intestine biopsy within a week after the last dose of the antibody.
Interventions
- BIOLOGICAL Hu-Mik- Beta-1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2013-06-12 |
| Est. Completion | 2019-12-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01893775
The ClinicalTrials.gov registry entry for NCT01893775 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Hu-Mik- Beta-1 is the first listed.
NCT01893775 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01893775 about?
NCT01893775 is a clinical study titled "Antibody Treatment for Advanced Celiac Disease". Background: \- Celiac disease is a condition where the immune system attacks the cells of the small intestine. The intestine becomes inflamed and cannot digest food properly. The disease most often causes a reaction to foods that contain gluten. Most people can treat celiac disease with a gluten-fr...
What is the current status of trial NCT01893775?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2013-06-12. Estimated completion is 2019-12-20.
What interventions are being tested in trial NCT01893775?
The interventions under investigation include: Hu-Mik- Beta-1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01893775?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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