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NCT00128193 · ClinicalTrials.gov registry record · Phase 2
Leprosy Skin Test Antigens Trial
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 260
- Enrollment target
NCT00128193 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 260 participants.
The verdict
NCT00128193, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 260 participants
- Enrollment target
Study Summary
The purpose of this study is to see how healthy people and leprosy patients react to 2 new skin tests for detecting leprosy. The study will evaluate the new skin tests that may aid in measuring the number of people exposed to leprosy and enable its diagnosis and treatment at an earlier stage. Participant's ages 18-60 living in Kathmandu, Nepal will be enrolled. Stages A and B of the study will use the skin test in healthy volunteers. Stage C will use the skin test in high risk volunteers (including individuals with leprosy), healthy individuals in contact with leprosy patients and individuals with tuberculosis (TB, lung disease). Study procedures will include injections, physical exam, and blood testing. Injection sites will be checked several times during the participant's study involvement (5 hours of time spread over approximately 1 month). Volunteers screened for the study, which have leprosy or tuberculosis will be treated or referred for treatment.
Interventions
- OTHER Placebo
- BIOLOGICAL Tuberculin, Purified Protein Derivative
- OTHER MLSA-LAM
- OTHER MLCwA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2002-04 |
| Est. Completion | 2009-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00128193
The ClinicalTrials.gov registry entry for NCT00128193 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00128193 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00128193 about?
NCT00128193 is a clinical study titled "Leprosy Skin Test Antigens Trial". The purpose of this study is to see how healthy people and leprosy patients react to 2 new skin tests for detecting leprosy. The study will evaluate the new skin tests that may aid in measuring the number of people exposed to leprosy and enable its diagnosis and treatment at an earlier stage. Partic...
What is the current status of trial NCT00128193?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 260 participants. The study started on 2002-04. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00128193?
The interventions under investigation include: Placebo (OTHER), Tuberculin, Purified Protein Derivative (BIOLOGICAL), MLSA-LAM (OTHER), MLCwA (OTHER).
Who is sponsoring clinical trial NCT00128193?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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