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| Sponsor: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Collaborator: |
University of Alabama at Birmingham |
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004471 |
Purpose
OBJECTIVES:
Determine whether copies of the cystic fibrosis gene (pGT-1) can be delivered to the cells lining the nose of cystic fibrosis patients using cationic liposome (DMRIE/DOPE) mediated gene transfer.
| Condition | Intervention | Phase |
|---|---|---|
|
Cystic Fibrosis |
Gene Transfer: pGT-1 gene lipid complex |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Estimated Enrollment: | 9 |
| Study Start Date: | August 1995 |
PROTOCOL OUTLINE: Under direct visualization, patients receive lipid/DNA formulation (pGT-1 lipid complex) by syringe instillation over 30 minutes to the right inferior nasal turbinate.
Patients are followed daily for 7 days, twice a week for 3 weeks, every 2-3 weeks for 10 weeks, then every 3 months thereafter.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations
More Information
| Study ID Numbers: | 199/13941, UAB-6097, UAB-F930923001 |
| Study First Received: | October 18, 1999 |
| Last Updated: | June 8, 2006 |
| ClinicalTrials.gov Identifier: | NCT00004471 History of Changes |
| Health Authority: | United States: Federal Government |
|
cardiovascular and respiratory diseases cystic fibrosis genetic diseases and dysmorphic syndromes rare disease |
|
Pathologic Processes Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis |
Fibrosis Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases |